29  

2.2.1  The  use  of  thermal  imaging  in  the    medical  diagnosis  of  fractures    

As   the   technology   has   improved   and   become   more   reliable   the   research  

methodology   and   rigor   demonstrated   has   been   enhanced,   ensuring   more  

accurate  data  capture  and  reproducibility  of  results  (Ring  &  Ammer,  2012,  p.  33).  

The  most   relevant   paper   to   this   study  was   conducted   by   Silvia   et   al.   (2012,   p.  

1007-­‐1015).  They  used  digital   infrared  thermal  imaging  in  paediatric  extremity  

trauma  to  investigate  whether  thermal  imaging  would  be  useful  in  the  diagnosis  

of   fractures   and   in   locating   areas   of   pain.   Their   study   examined   51   children  

presenting   to   a   Children’s   Emergency   Department   in   the   United   States   of  

America.    

 

Silvia   et   al.   (2012)   hypothesised   that   fractures  would   be   associated  with   local  

hyperthermia,  detectable  with  Digital   infrared  imaging  (DITI)  which  could  then  

direct  focused  radiographs.      Their  study  was  carried  out  over  2  months  in  which  

they   used   thermal   images   to   detect   “hot   spots”   which   correlated   to   73%   of  

injuries  and  detected  7  out  of  11  fractures.  Rather  than  recording  temperature  of  

the  injury  site  they  relied  on  the  visualisation  of  localised  “hot  spots”,  taking  the  

hottest  point  as  the  injury  site/fracture.      

 

This   study   had   a   limited   sample   size   with   only   11   fractures   recorded.   All  

fractures  occurred  in  the  distal  limb  segment  so  the  researchers  were  unable  to  

comment  on  the  use  of  DITI  to  detect  proximal  limb  fractures.  This  study  made  

no   attempt   to   follow   standard   DITI   preparation   protocol,   which   may   have  

resulted   in   the   suboptimal   results   recorded.   The  major   concern   regarding   the  

    30  

methodology   carried   out   for   this   study   was   the   lack   of   strict   standardisation  

regarding  the  digital  infrared  thermography  preparation  preceding  the  imaging.    

 

The   researchers   (Silvia   et   al.   2012)   were   concerned   that   this   standardisation  

would  take  too  long  to  set  up  and,  given  the  time  constraints  placed  upon  them  

within   a   busy   emergency   department,   this   protocol   was   impractical.   This   is   a  

major   flaw   within   this   research   study   because   this   standardisation   of  

preparation   is   essential   in   order   to   produce   results   that   are   both   reliable   and  

reproducible  (Plassmann,  Ring  &  Jones,    2006,  p.  10;  Ring  &  Ammer,  2000,  p.  7;  

Ring  &  Ammer,  2012,  p.  34).  This  study  made  no  attempt  to  analyse  or  record  the  

individual  temperatures  of  the  effected  limb  and  thus  relied  solely  on  detecting  

hot-­‐spot   visualisation,  which   could   affect   the   sensitivity   of   the   study  hugely   as  

this  only   records   temperature  differences  of  1-­‐2°C.  However,   this   is  difficult   to  

quantify  as  no  sensitivity  rating  for  the  camera  is  mentioned  within  this  paper.  

   

Another  relevant  study  was  carried  by  Hosie  et  al.  (1987,  pp.  117-­‐20)  who  used  

liquid  crystal  thermography  (LCT)  to  examine  whether  thermal  images  could  be  

used  to  detect  fractures  in  the  wrist  specific  to  the  scaphoid  bone.  Fifty  patients  

were   enrolled   into   the   study   with   suspected   scaphoid   fractures,   all   of   the  

patients  were  brought  back  after  10  days  and  had  their  wrists  X-­‐rayed  a  second  

time   and   thermal   images   taken   of   both   the   injured   and   uninjured   wrist.   The  

researchers  noted  the  temperatures  of  both  the  injured  and  uninjured  limbs  and  

deduced   that   a   temperature   difference   would   signify   a   fracture;   this   was   in  

association  with  the  then  gold  standard  scaphoid  series  of  X-­‐rays.  The  researcher  

found  when  comparing  the  LCT  with  conventional  X-­‐rays  there  were  three  false  

    31  

negatives   giving   a   sensitivity   of   77%   with   seven   false   positives   giving   a  

specificity  of  82%.  The  overall  accuracy  was  80  %;  if  the  scan  was  negative  then  

the  negative  predictive  value  was  over  90%,  suggesting  that  the  thermal   image  

was  more  useful  in  ruling  out  fractures  rather  than  ruling  them  in.  The  authors  

deduced   that   it   would   be   a   useful   test   to   be   carried   out   on   patients   with  

suspected  scaphoid   fracture  as   it  was  non-­‐invasive,  cheap  and  required   limited  

technical  ability.  However  this  does  highlight  the  problems  associated  with  LCT;  

in  the  1980s  the  technology  was  very  user  dependent  (Ring  &  Ammer,  2000,  p.  

12)  and  could  only  measure  temperature  differences  of  1°C  or  more.  One  could  

also   argue   that   the   reference   standard   for   this   paper,   in   terms  of   X-­‐rays   being  

used  as  the  gold  standard  for  the  detection  of  scaphoid  fracture,  is  out  of  date  as  

small   limb   MRE   would   be   used   as   the   gold   standard   in   current   practice  

(Memarsadeghi  et  al.,  2006,  pp.  169-­‐176;  Beeres  &  Hogervorst,    2008,  pp.  950-­‐

54).    

 

Another   study,   which   examined   the   use   of   thermography   in   distal   radius  

fractures,  was   carried   out   by   Birklein,   Schmelz,   Schifter   and  Weber   (2001,   pp.  

2179–2184).   The   researchers   used   thermography   in   order   to   analyse   the  

pathophysiology  behind  the  clinical  similarity  of  limb  trauma  and  acute  stages  of  

complex   regional   pain   syndrome   (CRPS).   Birklein   et   al.   examined   20   patients  

with  external  fixation  after  distal  radius  fracture  (3.5  days  after  surgery)  without  

signs  of  CRPS  and  24  patients  suffering  from  acute  CRPS  I  (without  nerve  lesion;  

duration,   5   weeks).   Hyperalgesia   to   heat   was   tested   by   a   feedback-­‐controlled  

thermode   and   tested   against   a   mechanical   stimulus   by   an   impact   stimulator.  

They  used  infrared  thermography  to  measure  skin  temperature  to  examine  the  

    32  

sympathetic   nervous   system.   They   also   used   laser–Doppler   flowmetry   to   test  

different  sympathetic  vasoconstrictor  reflexes  and  quantitative  sudometry  after  

thermal   load   (thermoregulatory   sweat   test).   They   found   hyperalgesia   to   heat  

after  trauma  (P<0.001),  but  not   in  CRPS,  whereas  mechanical  hyperalgesia  was  

present   in   both   patient   groups   (trauma:   P<0.001;   CRPS:   P<0.005).   Skin  

temperature   was   significantly   increased   on   the   affected   side   in   both   patient  

groups  (acute  trauma:  P<0.001;  CRPS:  P<0.005).  This  study’s  results  suggest  that  

thermography  can  be  used  to  detect  abnormalities  in  injured  limbs,  however  the  

author   highlighted   that   the   temperature   difference   between   a   normal   healing  

fracture  and  that  of  a  patient  with  CRPS  was  limited.    

 

Gradl,  Stenborn,  Wizgall,  Mittlemeir  and  Schurmann  (2003,  pp.  1020  –  6)  carried  

out  a  follow  up  study  to  the  one  described  above.  In  this  study  the  focus  was  on  

the  early  diagnosis  of  CRPS  in  patients  with  distal  radial  fractures.  For  the  study  

158   consecutive   patients   with   distal   radial   fractures   were   followed-­‐up   for   16  

weeks  after  trauma.  Apart   from  a  detailed  clinical  examination  8  and  16  weeks  

after   trauma,   thermography   and   bilateral   radiographs   of   both   hands   were  

performed.   At   the   end   of   the   observation   period   18   patients   (11%)   were  

clinically  identified  as  CRPS.  The  severity  of  the  preceding  trauma  and  the  chosen  

therapy  did  not  influence  the  process  of  the  disease.  16  weeks  after  trauma  easy  

differentiation   between   normal   fracture   patients   and   CRPS   patients   was  

possible.   8   weeks   after   distal   radial   fracture   clinical   evaluation   showed   a  

sensitivity  of  78%  and  a  specificity  of  94%.  However,  thermography  (58%)  and  

bilateral   radiography   (33%)   revealed   poor   sensitivity   respectively.   The  

specificity   was   high   for   radiography   (91%)   and   again   poor   for   thermography  

    33  

(66%),  respectively.  Gradl  et  al.  concluded  that  plain  radiography  was  better  to  

determine  diagnosis  of  CRPS  and  radial  fractures  due  to  the  problems  associated  

with  sensitivity  and  specificity  noted  above.    

 

A  study  carried  out  by  Niehof,  Beerthuizen,  Huygen  and  Zijlstra  (2008,  pp.  270-­‐

7)   examined   the   use   of   thermography   again   in   the   field   of   detecting   complex  

regional  pain  syndrome  (CRPS).      In  this  study,  they  assessed  the  validity  of  skin  

surface  temperature  recordings,  based  on  various  calculation  methods  applied  to  

the  thermographic  data,  to  diagnose  acute  complex  regional  pain  syndrome  type  

1   (CRPS1)   in   fracture   patients.   They   used   thermographic   recordings   of   the  

palmar/plantar   side   and  dorsal   side  of   both  hands   and   feet   on  CRPS1  patients  

and   in   control   fracture  patients  with   and  without   complaints   similar   to  CRPS1  

just  after  removal  of  plaster.  Various  calculation  methods  were  used  to  examine  

the  thermographic  data.  They  found  that  the  injured  side  in  CRPS1  patients  was  

often   warmer   compared   with   the   uninjured   extremity.   The   difference   in  

temperature   between   the   injured   site   and   the   uninjured   extremity   in   CRPS1  

patients   significantly   differed   from   the   difference   in   temperature   between   the  

contra-­‐lateral  extremities  of  the  two  control  groups.      

 

Exact   numbers   within   this   study   group   were   not   published   so   the   true  

significance   of   this   research   cannot   be   fully   examined.     However,,   the   largest  

temperature   difference   between   extremities  was   found   in   CRPS1  patients.   The  

difference   in  temperature  recordings  comparing  the  palmar/plantar  and  dorsal  

recording  was  not  significant  in  any  group.  The  sensitivity  and  specificity  varied  

considerably   between   the   various   methods   used   to   calculate   temperature  

    34  

difference  between  extremities.  The  highest  level  of  sensitivity  was  71%  and  the  

highest   specificity   was   64%;   the   highest   positive   predictive   value   reached   a  

value   of   35%   and   the   highest   negative   predictive   84%.   They   concluded   by  

suggesting   that   the  use  of   thermography   to  discriminate  between  acute  CRPS1  

fracture  patients  and  fracture  patients  without  the  complaint  is  limited  and  only  

useful  as  a  supplementary  diagnostic  tool.    

 

Hosie   et   al.   (1989)   found   that   thermal   imaging   was   useful   in   detecting   some  

scaphoid   injuries,   suggesting  a  sensitivity  of  88%  and  overall  accuracy  of  80%.  

However,  this  was  using  equipment  that  was  out  dated  and  very  complicated  to  

use.   Hosie   et   al.   (1989)   used   Liquid   Chrystal   Thermograph   technology   that   is  

unreliable  when  detecting  temperature  differences  below  1˚C,  meaning  that  the  

more  subtle  temperature  differences  between  soft  tissue  and  bony  injury  would  

not   have   been   detected   (Sarbina,   2010;   Jung   and   Zuber,   1998).   Hosie   et   al.  

(1989)   and   Silvia   et   al.   (2012,   pp.   1007-­‐1015.)   both   conclude   that   thermal  

imaging   should   be   used   as   a   pre-­‐screening   tool   to   decide   whether   further  

diagnostics   were   required.   However,   neither   study   suggested   that   thermal  

imaging   could   be   used   exclusively   to   detect   fractures  when   tested   against   the  

gold  standard  of  X-­‐rays.    

 

The  papers  reviewed  here  do  suggest  that  thermography  can  detect  temperature  

changes   in   injured   limbs   when   compared   to   the   uninjured   limb   (Hosie   et   al.  

1989)  and  Silvia  et  al.  (2012,  pp.  1007-­‐1015.).  However,  the  evidence  highlights  

the   inability   of   thermography   to   determine   the   severity   of   inflammation  

    35  

surrounding  the  fracture  site  and  the  determination  of  whether  the  image  results  

will  highlight  the  difference  between  a  fracture  and  that  of  a  soft  tissue  injury.    

 

Devereaux,   Parr,   Lachman,   Page-­‐Thoma   and  Hazleman   (1984,   pp.   531-­‐3)   used  

thermography  to  investigate  eighteen  patients  with  shin  pain,  caused  by  a  stress  

fracture   of   the   tibia   or   fibula.   All   the   patients   in   this   study   underwent  

radiological,   thermographic,   and  scintigraphic   studies  and  a   test  of  ultrasound-­‐

induced  pain.  When  they  were  initially  assessed,  15  (83%)  had  stress  fractures  

confirmed   by   scintigraphy.   Of   these,   12   (80%)   had   abnormal   thermograms,   8  

(53%)   had   positive   test   results   for   ultrasound-­‐induced   pain   and   7   (46%)   had  

abnormal   radiographs.   Thermography   used   alone   seemed   to   be   a   safe,   rapid  

means  of  diagnosis  for  stress  fractures  in  the  tibia  or  fibula  with  no  relationship  

to  symptom  duration.  In  the  radiologically  normal  group  of  stress  fractures,  four  

(50%)   had   positive   test   results   for   ultrasound   stress   tests   and   normal  

thermograms.  Although   this  was  a  small   study  (N=18),   the  results   suggest   that  

thermology  can  be  used  to  rule  out  the  presence  of  fractures.  Conversely,  given  

the   relatively   high   false   positives,   one   can  deduce   that   it   has   relatively   limited  

use  in  positively  identifying  fractures.    

 

Posinkovic,   &   Pavlovic   (1989,   pp.   166-­‐173)   followed   up   this   research   by  

endeavoring   to   determine   the   major   causes   of   stress   fracture   and   determine  

whether   early   detection   could   result   in   improved   clinical   management.   His  

research  carried  out  over  a  period  of   five  years  examined  how  stress   fractures  

were   formed   and   how   they   could   be   diagnosed   early   on   following   injury.   He  

found  that  X-­‐ray  was  a  poor  diagnostic  indicator  for  the  early  detection  of  stress  

    36  

fractures,   instead   finding   that   CT,   ultra   sound   and   thermography   were   much  

better  at  detecting  early  pathology.    Having  determined  that  thermography  could  

be  useful   in  detecting  stress   fractures   in   lower   limbs,  DiBenedetto  et  al.   (2002,  

p.390)  investigated  whether  thermography  could  be  used  to  assess  the  severity  

of  foot  injury  during  basic  military  training.  With  the  use  of  thermographs  they  

determined   normal   foot   parameters   (from   30   soldiers   before   training),  

thermographic   findings   in   different   foot   stress   fractures   (from   30   soldiers   so  

diagnosed),   and   normal   responses   to   abnormal   stresses   in   30   trainees   who  

underwent   the   same   training   as   the   previous   group   but   did   not   have  

musculoskeletal  complaints.      

 

DiBenedetto  et  al.   (2002,  p.  390)   found   that   thermograms  of   injured   feet   show  

areas   of   increased   heat,   but   excessive   weight-­‐bearing   pressures   on   feet,   new  

shoes,  or  boots  also  cause  increased  infrared  emission  even  without  discomfort.  

They   concluded   that   the   differentiation   between   normal   foot   pathology   and  

abnormality   detection   using   thermology   was   challenging.   However,   by  

continuously   monitoring   the   soldiers   feet   and   identifying   the   soldiers   normal  

foot  pathology   in   terms  of  heat   signatures,   thermography  could  detect   signs  of  

early  injury  and  that  the  increased  heat  signature  could  be  used  to  detect  stress  

fractures.   Although   specific   injury   diagnoses   remained   difficult,   its   greatest  

benefit   was   established   as   its   ease   of   use   in   follow-­‐up   in   order   to   monitor  

severity  and  healing.    

A  similar  study  examining  the  use  of  thermography  to  monitor  bone  healing  and  

predict   complications   post-­‐orthopaedic   surgery   was   carried   out   by   Merkulov,  

Dorokhin,  Sokolov  and  Mininkov  (2008,  pp.  116  -­‐123)  which  studied  over  3500  

    37  

cases   of   long   bone   fractures   in   children   and   adolescents,   analyzing   the   bone  

healing   process   using   objective   methods   including   ultra   sound,   Computerised  

Tomography   (CT),   osteodensitometry,   thermography,   polarography,   and  

radionuclide   studies.   A   group   of   patients   with   delayed   consolidation   of   bone  

fragments   was   distinguished   based   on   the   results   of   clinical   and   instrumental  

investigations.  He  used  the  result  of  this  research  to  develop  diagnostic  criteria  

for  the  early  recognition  of  delayed  healing.  Thermal  imaging  was  used  to  detect  

temperature  difference  in  the  affected  limbs,  which  managed  to  map  the  degree  

of  healing  associated  with  limb  warmth,  however,  thermography  was  not  used  in  

isolation  but  as  a  conduit  to  other  diagnostic  tests.  This  study  was  similar  to  one  

carried  out  on  children  with  Perthe’s  disease  by  Bajtay  &  Györ  (1988,  p.  1).    

 

By  means   of   thermography   the   researcher   carried   out   examinations   on   seven  

children  suffering  from  the  disease,  finding  hypothermia  of  the  entire  lower  limb  

on   the   affected   side.   Although   not   obviously   useful   in   isolation   as   a   test   for  

Perthe’s   disease,   thermal   imaging   may   be   useful   in   the   identification   and  

classification   of   the   disease   process   and   where   conservative   management   is  

decided  upon  it  would  be  a  non-­‐invasive  way  of  monitoring  progress  rather  than  

the  invasive  harmful  effects  of  serial  radiographs.    

 

Sherman  &  Bruna  (1987,  pp.  1395-­‐402)  used  thermographic  recordings  of  body  

temperature  on  30  consecutive  amputees  who  reported  stump  and/or  phantom  

limb  pain.  Each  subject  participated  in  between  two  and  four  recording  sessions.  

Whenever   possible,   subjects   came   for   recording   sessions   when   their   pain  

intensity  was  different  from  that  of  previous  sessions.  He  found  that  a  consistent  

    38  

inverse  relationship  occurred  between  intensity  of  pain  and  stump  temperature  

relative  to  that  of  the  intact  limb  for  burning,  throbbing  and  tingling  descriptions  

of  both  phantom  and  stump  pain.  Heat  emanating  from  the  limbs  is  an  accurate  

reflection  of  near-­‐surface  blood  flow.  For  the  subjects  giving  these  descriptions  

of   pain,   tensing   the   limb   was   followed   by   a   decrease   in   blood   flow   and   an  

increase  in  pain.  Thermography  was  used  effectively  to  monitor  the  management  

of  the  patient’s  pain  management  and  stump  wound  healing  process  (Sherman  &  

Bruna,  1987  p.  1400).  Although   this  study   is  not  directly  useful   to   the  author’s  

study,  it  does  highlight  that  thermography  may  be  an  excellent  diagnostic  tool  to  

measure   the   inflammatory   process   and   the   acuity   and   the   severity   of   the  

traumatic  event.    

 

Another   such   paper,  which   can   inform   the  methodology   chosen   for   this   paper  

and   the  use  of   thermography  as   a  diagnostic   tool   in   the   inflammatory  process,  

was   carried  out  by   Siegel,   Siqueland  and  Noyes   (1987,   pp.   825-­‐30).  They  used  

thermography   to   evaluate   eight   patients   with   the   complaint   of   non-­‐traumatic  

anterior   knee   pain.   Thermograms   were   recorded   before   and   after   subjects  

performed   a   specific   rehabilitation   program.   The   thermographic   imaging   was  

then   repeated   4   to   8   weeks   after   the   initial   thermogram.   Among   the   subject  

group,  thermal  asymmetries  were  noted  in  the  involved  knees,  though  a  specific  

abnormal  thermal  pattern  could  not  be  recognised.  Changes  in  temperature  and  

thermal   patterns   after   exercise   and   over   time   were   consistent   within   each  

subject,  although  not  consistent  between  subjects.  Thermal  asymmetries  did  not  

appear   to   resolve   over   time.   It   was   felt   by   Siegel   et   al.   that   the   pathology  

investigated  by  this  study  might  involve  many  an  etiologies,  therefore  making  it  

    39  

difficult   to   establish   a   single   abnormal   thermal   pattern   with   regard   to   non-­‐

traumatic  anterior  knee  pain.  

 

Although  limited   in  numbers  and  with  variable  scientific  rigor,   these  papers  do  

support   the   hypothesis   presented   within   the   title   of   this   paper   that   thermal  

imaging   may   be   useful   in   detecting   fractures   in   children’s   wrists   following  

trauma.   However,   what   these   papers   do   not   demonstrate   is   the   quantifiable  

temperature  difference  between  an  uninjured   limb,  a   fracture  and  a  soft   tissue  

injury.  Despite  this  the  research  does  demonstrate  some  attempt  to  distinguish  

between   temperature   and   injury.   Birklein   et   al.   (2001,   p.   2180)   suggest   a  

significance   between   the   temperature   gradient   of   a   soft   tissue   injury   when  

measured  against  a  healing  fracture.  Hosie  et  al.  (1987,  p.  119)  suggested  that  a  

temperature  gradient  greater  than  1°C  could  signify  a  fracture,  however  this  was  

using  very  primitive  and  out  dated  diagnostic  equipment,  unlike  modern  thermal  

imaging   equipment   which   are   capable   of   detecting   differences   of   0.01°C.   The  

studies  do  highlight  and  justify  the  need  for  further  research  in  this  area  as  all  of  

the   studies  presented  have  produced  positive   results.  However,   the  need   for   a  

strict   methodological   approach,   along   with   the   need   of   a   controlled   imaging  

environment,  is  vital  and  supported  in  every  paper  reviewed  for  this  thesis.  

 

2.2.3  Further  alternatives  to  X-­‐ray.  

Another  alternative   to  X-­‐rays   for   the  detection  of  distal   radius   fractures  within  

the  paediatric  population  has  been  carried  out  exploring  the  use  of  ultra  sound  

as  a  diagnostic  tool.  Four  papers  have  been  published  into  the  use  of  ultra  sound  

versus  X-­‐ray  with  very  promising  results  (Tej  et  al.,  2011,  p.  443;    Hubner  et  al.,  

    40  

2000,   p.   1117;  Williamson,  Watura,   &   Cobby,   2000,   p.   22).   Each   of   the   papers  

published  reported  a  sensitivity  of  over  97%  with  a  specificity  of  91%.  The  four  

papers  have  similarites  in  design  in  the  fact  that  they  are  all  prospective  cohorts  

comparing  a  new  diagnostic  test  against  the  gold  standard  of  X-­‐ray,  similar  to  all  

of   the   thermal   imaging   studies   carried   out   in   the   literature   review   above.   All  

except  one  of  the  studies  recruited  small  numbers  which  would  clearly  effect  the  

sensitivity  and  specifity  obtained  (Guiffre,  1994,  p.  334).  The   largest  study  was  

carried  out  in  Germany  by  Hubner  et  al.  (2000,  p.  1117)  where  163  patients  were  

enrolled   into   the   study  with   over   224   suspected   fractures   (some   patients   had  

more   than   one   supsected   fracture).   Three   paediatric   surgeons   carried   out   the  

scans,  scanning  all  four  planes  of  the  suspected  fracture  sites;  all  of  the  patients  

recieved  X-­‐rays  of  the  fracture  sites  and  the  results  analysed.  Each  of  the  studies  

used  a  convenience  sample  for  their  study  group,  this  is  often  unavoidable  when  

carrying  out  real  world  research  when  using  the  clinical  setting  for  the  research  

environment,  though  it  can  lead  to  the  introduction  of  selection  bias  .  The  studies  

did   have   a   variation   in   the   degree   of   ultrasound   experienced   doctors,   which  

could  affect  the  published  results.  However,  these  papers  did  suggest  that  ultra-­‐

sound  could  detect  fractures  in  children  and  couild  be  used  as  an  alternative  to  

X-­‐rays,  but  children  did  complain  that  the  procedure  was  painful.    These  papers,  

although   focussing   on   ultrasound,   are   extremely   useful   for   informing   the  

development  of   the  methodology  used   for   this  study  as   they  clearly  have  great  

similarities.   Nonetheless   there   is   an   exception   to   this   as   thermal   imaging   is  

totally   non-­‐invasive   whereas   ultrasound,   although   not   being   harmful,   does  

require  contact  with   the   limb  and  may  produce  a  degree  of  discomfort  when  a  

fracture  or  soft  tissue  injury  is  present.      

    41  

2.2.5  Limitations  associated    with  thermal  imaging    

Much  of  the  research  surrounding  the  use  of  thermal  imaging  suggests  that  it  can  

be  used  very  successfully  as  a  diagnostic  adjunct   in  clinical  practice.  However   ,  

the   papers   reviewed   also   highlight   the   clinical   vulnerability   of   the   technology.  

The  use  of   thermal   imaging  equipment  appears   to  be  very  user  dependent  and  

often   not   reliable   or   results   generalisable,   as   highlighted   in   the   contradictory  

results  reported  in  much  of  the  published  research  reviewed.    An  example  of  this  

can   be   seen   in   the   early   detection   of   breast   cancers  where   the   use   of   thermal  

imaging   has   fallen   in   to   disrepute   (Ammer,   2006,   p.   16).   This   observation   has  

dominated   the   research   carried   out   at   the   University   of   Glamorgan   medical  

imaging  research  unit,  led  by  Professor  Ring.  Ring  and  Ammer  (2000,  pp.  7  -­‐14)  

have  set  out  standards  that  should  always  be  followed  when  conducting  research  

into   thermal   imaging   as   part   of  medical   research.  Much   of   this   paper   and   the  

department’s   findings   will   be   discussed   in   the   methodology   chapters   of   this  

thesis  as  all  of  the  recommendations  were  followed  in  the  research  design.    

 

Plassmann   et   al.   (2006,   p.   11)   highlighted   the   need   for   frequent   servicing   and  

maintenance  on  the  equipment  used  as,  without  this  maintenance,  considerable  

drift   in   the   temperature   variable   can   occur  with   a   drift   of   up   to   4˚C   reported,  

which  is  significant  given  that  most  research  studies  report  temperature  changes  

of   0.1˚C   –   1˚C   as   clinically   significant   (Jung   and   Zuber   1998,   p.   19).   Thermal  

imaging  is  a  non-­‐contact,  non-­‐invasive  diagnostic  method  for  the  study  of  human  

body   temperature.   Therefore,   as   highlighted   in   this   literature   review,   infrared  

thermal   imaging   may   have   increasing   applications   in   clinical   medicine   as   the  

technology  becomes  more  sensitive  and  refined.    

    42  

Since   the   1970's   thermography   has   been   used   across  many   areas   in  medicine.  

Early   problems   such   as   low   detector   sensitivity   and,   most   significantly,   poor  

training   of   the   mammography   technicians   was   the   source   of   error   in  

thermography   and   retarded   the   acceptance   of   this   technique   until   1990.   Since  

that   time,   thermographic   equipment  has  evolved   significantly.  Modern   thermal  

imaging  systems  comprise  of   technically  advanced   thermal  cameras  coupled   to  

computers  with  sophisticated  software  solutions.  The  recorded  images  are  now  

of  good  quality  and  may  be   further  manipulated  to  obtain  reliable   information.  

Thermography  can  be  applied  as  a  diagnostic  tool  in  oncology,  allergic  diseases,  

angiology,   plastic   surgery,   rheumatology   and   specific   childhood   conditions  

(Ammer,  2006,  p.  17).    

 

This   review   has   highlighted   that   contemporary   thermal   imaging   must   be  

performed  according  to  certain  principles  aimed  at  reliability  and  reproducibility  

of   results.   Ignoring  any  of   the  principles  described  by  European  Association  of  

Thermology  leaves  the  research  study  open  to  criticism  and  error,  thus  reducing  

acceptance   of   this   technique   in  medical   diagnostics.   This   literature   review  has  

demonstrated   evidence   that   thermal   imaging   can   detect   changes   in   body  

temperature   due   to   the   exothermic   reaction   of   the   inflammatory   response  

caused   by   a   fracture   to   a   bone.   However,   it   has   highlighted   the   failings   of   the  

technology  and  the  inconsistent  nature  of  technology  to  date.  None  of  the  studies  

reviewed  commented  on  expense  when  compared  to  X-­‐rays  or  the  time  taken  to  

carry  out   the  diagnostic  procedure.  This   study  will   explore   these   issues  within  

the   discussion.   The   key   points   raised   by   this   review   are   to   ensure   that   the  

research  methodology  used  for  this  study  is  rigorous  and  reproducible.  All  of  the  

    43  

studies   reviewed   above   have   demonstrated   the   difficulty   in   carrying   out   this  

type   of   research   in   regards   to   managing   the   control   group,   controlling   the  

circulating  air  and   temperature  around   the   test   subject   in  order   to  get   reliable  

and  meaningful  readings  and  the  need   for  a  consistent  and  reproducible   image  

which  will  encompass  all  of  the  above.  The  methodology  for  this  study  has  been  

adapted  accordingly,   using   the   lessons   learnt   from   the   reviewed   literature  and  

advice  given  by  Professor  Ring  and  his  colleagues  at  Mid  Glamorgan  University.        

 

                           

    44  

Chapter  3                                            

    45  

 Chapter  3:  Research  design  and  Sampling      This  chapter  will  describe  the  research  methodology  used  to  investigate  the  research  

question  posed  and  the  design  strategy  used  to  achieve  the  primary  and  secondary  

objectives   set   for   this   study.   The   chapter  will   describe   the   conceptual   framework  

used  to  determine  the  methodology  and  its  influence  on  the  pilot  study  design.  The  

rationale   for   the  pilot  study  design  will  be  presented  along  with   the  description  of  

the   quasi-­‐experimental   design   used.   The   patient   population   and   methods   of   data  

analysis  will  be  discussed  along  with  the  inclusion  and  exclusion  criteria  described.  

Ethical  implications  of  the  study  will  be  presented  and  discussed  within  this  chapter.        

3.1  Conceptual  framework    

The   researcher   has   used   a   conceptual   framework   to   organise   and   focus   the   study  

toward  the  area  of  thermal  imaging  and  the  detection  of  wrist  fractures  in  children.  

The   conceptual   framework   ensures   that   all   of   the  main   themes   and   concepts   are  

explored   within   the   literature   review.   These   themes   and   concepts   are   stated   and  

organised  within   a   conceptual  map   and   therefore   used   to   determine   the   research  

design  (Burns,  1997).  This  ensures  that  the  study  is  focused,  linking  the  concepts  of  

previous   studies   and   their   published   theories   to   the   present   study.   This   avoids  

replication  and  enhances  the  previously  gained  knowledge  rather  than  covering  old  

ground   (Newman,   1979).   The   researcher   has   used   the   conceptual   framework   to  

formulate  his  research  question  and  organise  his  study.  The  conceptual  framework  

used  for  this  study  is  illustrated  on  page  47,  figure  4.      

Crooke  and  Davies  (1998,  p.  106)  state  that  this  is  essential,  suggesting    

“no   research   study   should   be   commenced  without   a   full   enquiry   into   the   concept   surrounding   it   they  

define   the   conceptual   framework  as  an  organisation  or  matrix  of   concepts   that  provides   focus   for   the  

enquiry”.    

    46  

Figure  5:  Conceptual  framework      

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

    47  

 

3.2  Research  question    

 The   research   question   has   been   devised   using   Knottnerus   and   Muris’s   (2002)  

guidance  on  designing  research  questions  for  diagnostic  tests.  They  suggest  that  the  

question  must  have  a  contrast  to  evaluate,  the  clinical  problem  must  be  defined  and  

it  should  be  placed  in  the  context  of  the  clinical  setting.    The  research  question  has  

been  formulated  using  the  evidence  from  previous  studies  described  in  chapter  two  

and   the   aims   and  objectives   for   the   study  presented   in   chapter   1,   using   Sackett  &  

Haynes  (2002,  p.  20)  guidance  as  a  template.    

3.2.1Research  questions:  

1. Do  children  with  a   fracture  have  a  different   temperature  recording  to   those  

who  do  not  have  a  fracture?    

2. Are  children  with  a  higher  temperature  recording  in  their  injured  wrist  more  

likely  to  have  a  fracture  when  compared  to  the  control  (Uninjured  limb)?    

3. Among   patients   who   it   is   clinically   sensible   to   suspect   a   fracture   in   their  

wrist,   does   thermal   imaging   distinguish   those   patients   with   or   without   a  

fracture?  

Previous   literature  suggests  that   there   is  superficial  evidence  that   thermal   imaging  

can   be   used   to   detect   fractures   in   children.     Thus   this   pilot   study   will   explore  

whether  children  with  a  temperature  recording  greater  than  1°C  when  compared  to  

the  unaffected  limb  are  statistically  significantly  more  likely  to  have  a  fracture  than  

those  with  within  the  control  group.  A  case  study  carried  out  by  Cook  et  al.   (2005,  

pp.   395-­‐397)   highlighted   that   detection   of   a   child’s   fractured   distal   radius   by  

thermography   could   prove   useful   as   a   new  way   to   diagnose   fractures   in   children.  

    48  

Only   once   the   reliability   and   accuracy   of   thermography   in   detecting   fracture   in  

children’s  wrists  is  ascertained,  can  the  researcher  progress  onto  a  full  Phase  III  trial  

involving   larger   sample   sizes   and   multi-­‐centred   research   (Lancaster,   Dodd,   &  

Williamson,  2004,  p.  308;  Bowling,  2009;  Craig  et  al.,  2008,  p.  1655).    

 

The   hypothesis   posed   for   this   research   is   that   thermal   imaging   can   be   used   as   a  

diagnostic   tool   to  detect   fractures   in  children’s  wrists  (distal  ulna  and  radius);   this  

hypothesis   has   been   derived   from   the   literature   and   current   supporting   research  

surrounding  thermography.    

The   null   hypothesis   is   therefore   that   thermal   imaging   offers   no   benefit   or   is   not  

specific  or   sensitive  enough   to  detect   fracture   in   children’s  wrists   (Distal  ulna  and  

radius)  when  used  in  the  clinical  setting.  

   

As   the   pilot   study   is   hypothesis   driven   there   is   a   danger   that   the   researcher   can  

make   a   type   one   or   type   two   errors.   A   type   one   error   is   when   the   researcher  

concludes   that   the  null  hypothesis   is  wrong  when   it   is  actually  correct   (Polit  et  al.,  

2001,   p.   348).   This   can   occur   when   the   results   of   the   study   demonstrate   a   large  

degree  of  false  positives.  In  this  study  the  researcher  has  endeavored  to  reduce  the  

chance  of  causing  a  type  one  error  by  producing  a  control  group  and  by  conducting  a  

likelihood   ratios   test   (Straus,   Richardson,   Glasziou,   &   Haynes,   2005;   Cambell   and  

Stanley,  1963).  The  use  of  a  control  group  within  the  study  considerably  strengthens  

the   interpretation  of   the   results   (Maas  and  Buckwalter,   1998).  The   researcher  has  

also   attempted   to  minimise   the   risk   of  making   a   type   one   error   by   only   accepting  

significance   of     P<   0.05   (Polit   et   al.,   2001,   p.   351).   This   reduces   the   fears   that   the  

change   in   the   experimental   group   occurred   by   chance   rather   than   by   the   study’s  

    49  

manipulation  of   the  experimental  group.  A   type   two  error   is  where   the  researcher  

accepts  the  null  hypothesis  when  it  is  false  (Beya  and  Nicoll,  1997).  However  one  of  

the   major   reasons   for   conducting   this   study   initially   as   a   pilot   is   to   explore   the  

challenges   surrounding   sample   sizes   and  data   collection   to   inform   the   subsequent  

larger  phase  III  study  (Thabane  et  al.,  2010;  Lancaster  ,  Dodd,  &  Williamson,  2004,  p.  

309).  

3.3  Standard  approach  to  infrared  imaging  

 As  highlighted  within  the  literature  review  in  chapter  two,  some  of  the  early  studies  

involving   thermal   imaging   for  example  Ring  (2000)  and  Plassman  (2005)   failed   to  

gain  credibility  due  to  the  lack  of  a  standard  approach  to  the  imaging  applied.  Poor  

technique   and   knowledge   about   these   standard   procedures   have   led   to   thermal  

imaging  as  a  diagnostic  tool  being  discredited  and  ignored  within  the  main  stream  of  

medical  diagnostic  imaging  (Ring,  2004).  In  view  of  these  earlier  criticisms  and  the  

growing  popularity  of  thermal  imaging  research,  the  then  European  Thermography  

Association   developed   standards   for   carrying   out   diagnostic   studies   using   infra  

imaging  (Clark  &  DeCalcina-­‐Goff,  1997).  Ring  and  Ammer  (2000)  carried  out  a  meta-­‐

analysis   concentrating   on   all   of   the   previous   studies   conducted   and,   from   the  

evidence  gained  from  this  study,  established  standards  that  must  be  followed  when  

conducting  thermal   imaging  studies.  These  standards  concentrated  on  the   location  

of  thermal   imaging  equipment  when  imaging  was  taking  place,   the  accuracy  of  the  

imaging  equipment,  how  the  patient  was  positioned/manipulated  and  how  the  data  

from  the  images  was  captured  and  subsequently  reported.    

3.3.1  Location  of  thermal  imaging    

The   investigation   room   should   be   at   least   2x3  metres,   preferably   3x4  metres,  

    50  

with  room  for  the  patient  and  equipment  to  be  comfortably  positioned.  Mabuchi  

(1997)   suggests   that   the   room   should   have   an   ambient   temperature   ranging  

between   18-­‐25°C   and   should   be   kept   at   this   temperature   for   at   least   an   hour  

before  the  imaging  commences.  The  room  should  have  the  facility  for  additional  

cooling   if   required   and   a   large   digital   thermometer   displayed   to   ensure  

conformity   (Mabuchi,   Genno,   Matsumoto,   Chinzie,   &   Fujimasa,   1995).   For   this  

study   the   thermal   imaging   took   place   in   the   X-­‐ray   room,   which   is   kept   at   a  

constant   temperature   between   20-­‐25°C   controlled   by   air-­‐conditioning   and  

monitored  constantly  by  electronic  digital   thermometry.  The  rooms  were   large  

enough   to   accommodate   all   the   staff   involved   and   the  patient   and   their   family  

without   alteration   in   the   ambient   temperature   of   the   examination   room.   The  

room  is  lead  lined  which  meant  that  noise  interference  was  minimalised  as  this  

could  alter  the  reference  temperature  recorded  (Vardasca  &  Bajwa,  1995).    

 

3.3.2.  The  imaging  system    

The   imaging   system  must   be   specially   adapted   towards   medical   imaging   self-­‐

cooling,   able   to   process   the   image   independently   of   any   other   system   and  

provide  basic  quantification  of  the  image  produced.  The  camera  must  be  able  to  

self-­‐regulate  its  temperature  referencing  system  or  the  researcher  must  have  an  

external   source   of   temperature   referencing.   The   camera   should   be   tested   for  

optimal   performance   on   an   annual   basis   and   calibrated   to   ensure   accuracy  

(Plassmann,  Ring,  &  Jones,  2006)  

A  thermal  imaging  camera  (FLIR  SC640)  was  sourced  for  the  months  of  April  and  

May  2008  from  the  Engineering  and  Physical  Sciences  Research  Council  (EPSRC)  

instrument  pool.  The  camera  had  been  validated  and  calibrated  by  the  National  

    51  

Physiological   Laboratory   thus   ensuring   the   reliability   and   accuracy   of   the  

thermal   image  analysis.  The  camera  was  mounted  on  a  standard  camera  tripod  

stand   with   vertical   height   adjustment.   The   camera   was   turned   on   at   least   10  

minutes   before   the   image  was   taken   to   allow   for   stabilisation   of   the   image.   A  

specialist  image  processing  software  package  was  used  for  the  medical  imaging  

camera,   ensuring   the   reliability   and   accuracy   of   the   image   taken   and   the   data  

captured.   In   this   study   the   researcher   used   a   specialist   research-­‐imaging  

package,   THERMACAM   RESEARCHER   produced   by   Flir   systems   specifically  

designed   for   medical   imaging   processing,   with   accuracy   within   +/-­‐   0.1°   C  

recorded.    

 

3.3.3  Patient  manipulation      

Patient   information  regarding  the   imaging  procedure  must  be  provided,   ideally  

before  the  patient  is  called  for  imaging  (Ammer  &  Ring,  2004).  The  patient’s  skin  

must   be   devoid   of   cosmetics   or   any   topical   applications   as   this   may   cause   a  

barrier   between   the   skin   and   the   image   taken  which  would   affect   the   thermal  

image  taken  (Engal,  1984).  Those  patients  who  have  just  had  a  large  meal  or  hot  

drink   should   be   excluded   from   the   study   as   it   has   been   suggested   that   these  

factors   affect   the   thermal   image   recorded,   however   there   appears   to   be   little  

evidence   to   support   this   (Ring   &   Ammer,   2000).   There   is   some   evidence   to  

suggest  that  certain  food  types  can  either  raise  or  reduce  ones  core  temperature  

temporarily  (Mabuchi  et  al.,  1995)  however,  due  to   the  emergent  nature  of   the  

attendance  to  the  emergency  department,  nothing  could  be  done  to  control  this  

perceived  complication.    

 

    52  

On  arrival   to   the  department  or   imaging  centre   it   is   important   that   the  patient  

should  be  asked  to  sit  comfortably  for  a  set  period  of  time.  Ring  et  al.  (1976)  and  

Mabuchi  et  al.  (1995)  suggest  that  15  minutes  is  optimal  for  the  patient’s  blood  

pressure   and   skin   temperature   to   stabilise,   and   suggest   that   if   this   is   not  

achieved  then  this  is  likely  to  skew  the  results.  During  this  preparation  time  the  

patient  must  avoid  folding  or  crossing  his  /her  arms  and  legs  or  placing  their  feet  

on  cold  floor  if  the  lower  extremities  are  to  be  examined  (Ring  and  Ammer,  2000,  

p.  10).  Standard  views  should  be  taken  of  the  patient  as  per  radiology  standards  

and   in   some   cases   a   template   may   be   used   to   position   the   limb   in   the   same  

position   consecutively   (Plassmann,   Ring,   &   Jones,   2006).   The   position   of   the  

patient   for   scanning   and   in   preparation  must   be   constant.   Standing,   sitting   or  

lying   down   will   affect   the   surface   area   of   the   body   exposed   to   the   ambient  

temperature,   therefore   an   image   recorded   with   a   patient   in   a   sitting   position  

may  not  be  comparable  with  one  on  a  separate  occasion   in  a  standing  position  

(Ring  and  Ammer,  2000,  p.  10).    

 

3.3.4  Report  generation  and  data  capture    

 Most   software   packages   built   into  modern   thermal   imaging   equipment   have   a  

standard   approach   to   data   capture.   This   should   include   the   image   itself,   the  

demographic  data  and  measuring  tool  for  measuring  the  image.  The  colour  scale  

must  be  standardised.  The  default  colour  scale  is  often  to  show  white  as  hot,  then  

yellow,   then   red   (see   figure   5   below).   The   background   temperature   should   be  

avoided  if  at  all  possible,  by  placing  the  patients  limb  to  be  imaged  on  a  cool  or  

neutral   surface   i.e.   hardboard   template   or   cool   towels.   The   researcher   for   this  

    53  

study  used   the  X-­‐ray  plate   for   this  purpose  as   it   reduced   the  movement  of   the  

patients   limb   and   was   observed   to   be   a   neutral   temperature.   This   procedure  

ensured   picture   clarity   and   reduced   image   deprecation   making   it   much   more  

accurate  and  reproducible  (Ring  and  Ammer,  2000,  p.  11).  

 

Figure  6:  Example  of  thermal  image.      

3.4  The  research  design  

The   research   design   used   for   this   study   is   that   of   a   quasi-­‐experimental   approach,  

although   the   study   does   contain   all   of   the   characteristics   of   a   true   experimental  

design   (Maas   &   Buckwalter,   1998).   It   could   be   argued   that   there   is   no   true  

randomisation  and  that  the  control  is  not  free  of  external  influences,  by  the  fact  that  

the  unaffected  limb  of  the  study  group  is  to  be  used  as  the  control  and  not  random  

attendees   of   the   Emergency   Department.   Although   some   compromise   within  

experiments  is  acceptable  (Brewin  and  Bradley,  1989),  the  researcher  feels  that  this  

research  fits  more  readily  with  the  quasi-­‐experimental  design  approach  than  that  of  

a   randomised   control   trial   in   the   true   sense.   Within   the   literature   reviewed  

previously,   the   majority   of   these   studies   evaluated   followed   the   criteria   set   by  

Campbell   and   Stanley   (1963)   for   quasi-­‐experimental   design.   This   correlates   well  

with  a  similar  study  carried  out  by  Moody  et  al.   (1988)   in  a  review  of  720  nursing  

    54  

research   articles.   They   found   that   the   majority   of   these   studies   used   a   quasi-­‐

experimental  approach  rather  than  that  of  a  true  experimental  approach.  Maas  et  al.  

(1988)   argue   that   the   quasi-­‐experimental   approach   has   developed   far   beyond   the  

narrow,   passive   approaches   first   described   by   Campbell   and   Stanley   (1963).   They  

suggest   that   the  quasi-­‐experimental   approach   evolved   into   a  more   comprehensive  

and  active  process,  which   is  more  suited   to   clinical  practice.  Campbell   and  Stanley  

(1963)   suggest   that   quasi-­‐experimental   designs   are   sufficiently   probing   and   well  

worth  employing.  Brink  and  Wood  (1994)  support   this  view,  suggesting   that   these  

approaches  are  appropriate  for  answering  phase  III  questions  (Bowling,  2009),  thus  

defending  the  validity  of  the  quasi-­‐experimental  approach  and  enhancing  its  value  as  

a  research  approach.    

 

3.5  The  Quasi-­‐experimental  design    

The  study  has  adopted  a  quasi-­‐  experimental  approach,   involving  the  manipulation  

of   an   independent   variable   but   without   any   randomisation   (Polit   and   Hungler,  

1995).  The  chosen  design   involves  a  non-­‐equivalent  control  group  as  described  by  

Campbell  and  Stanley  (1974)  and  other  researchers:  

Non-­‐equivalent   design   is   defined   as   those   in   which   dependant   variable  

measures   are   obtained   for   an   experimental   and   comparison   group   (non-­‐

randomly   assigned)   before   and   after   the   introduction   of   the   independent  

variable  to  the  experiment  group  (Maas  &  Buckwalter,  1998).  

The  advantages  of  using  this  approach  is  that  it  reflects  and  is  directly  relevant  to  the  

‘True’  world  of  nursing/clinical  practice  (Maas    &  Buckwalter,  1998;  Robson,  2002)  

and   is   not   just   an   experiment   carried   out   within   the   artificial   surrounding,   using  

predetermined   experimental   samples.   However,   it   is   important   that   the  

    55  

environment   is   manipulated   to   ensure   optimum   effectiveness   for   the   equipment  

used.   This   design   allows   the   researcher   to   examine   the   true   diversity   of   the  

hypothesis  posed  and  reflects  a  more  valid  picture  of  the  population  and  the  clinical  

setting   chosen   (Knottnerus   &   Muris,   2002).   Methodologically   the   design   has   its  

advantages   as   it   tests   the   casual   hypothesis   often   witnessed   within   the   clinical  

setting.    

Maas  and  Buckwalter  state:    

‘Quasi   experimental  designs  provide   a   systematic   framework   for   answering  

the   questions   that   might   otherwise   be   left   to   subjective   analysis,   trial   and  

error   or   conclusion   drawn   from   compromised   experiments   in   which   rival  

casual  hypothesis  have  not  been  explicitly  evaluated  (1998,  p.  59).’  

 

Owens,   Slade   and   Fielding   (1996)   suggest   that   the   sheer   nature   of   the   quasi-­‐

experimental  design  adds  to  its  weaknesses.  The  fact  that  the  design  encourages  the  

researcher   to   examine   the   casual   hypothesis   and   to   interpret   differing   variables  

means   alternatives   to   interpretation   will   always   be   found.   This   suggests   that   the  

positive  results  gained  from  this  pilot  study  cannot  produce  unequivocal  evidence  to  

support  or  refute   the  hypothesis.  Nonetheless   it   can  provide   the  researcher  with  a  

clearer   and   more   accurate   view   in   order   to   initiate   a   phase   III   study,   which   will  

clarify   remaining   questions   (Owens   et   al.,   1996).   The   design   has   been   focused  

toward  the  guidance  afforded  to  researchers  by  Straus  et  al.  (2005,  pp.  67-­‐99).  

 

 

3.6  Methodology    

The   methodology   selected   for   this   study   follows   the   three   major   principles   as  

    56  

dictated  by  Straus  et  al.  (2005)  for  diagnostic  studies  as  outlined  below.    

 

3.6.1  Measurement:   the  reference  (Gold)  standard  measured  independently,   i.e.  blind  to  the  test  group.    

The   thermal   imaging   was   conducted   totally   independently   of   the   X-­‐ray   (Gold  

Standard)  by  the  researcher.  The  thermal  image  was  interpreted  post-­‐test  after  the  

research  phase  was  completed  and  independent  of  the  X-­‐ray  results.  The  researcher  

was   blinded   to   the   X-­‐ray   result   and   thus   reduced   the   chances   of   interpreter   bias.      

Both   tests  were  performed   independently   i.e.   the   thermal   image  was  not   taken  by  

the  radiographer  who  obtained  the  X-­‐ray  (Engal,  1984).  The  standard  against  which  

thermal   imaging   will   be   compared   is   the   formal   X-­‐ray   reporting   by   a   Consultant  

Radiologist  or  Reporting  Radiographer   (Meininger,  1998,  p.  218).  This  approach   is  

supported  by  Knottnerus  &  Muris  who  state:    

The   results   of   the   test   should   be   interpreted   without   knowledge   of   the  

reference   group   standard   results.   Similarly   the   reference   standard   result  

should  be  established  without  knowing  the  outcome  of  the  test  under  study  

(2002).    

This   greatly   reduced   the   chance   of   test   review   bias   and   ensured   blinding   of   the  

study.   It   also   reduced   the  diagnosis   review  bias,  which  often  occurs  when   there   is  

non-­‐independent  assessment  of   test   results,   resulting   in  overestimation  of   the   test  

(Knottnerus  &  Muris,  2002).  

3.6.2   Representative:   was   the   diagnostic   test   evaluated   in   an   appropriate  spectrum  of  patients.    The   diagnostic   test   was   carried   out   on   children   attending   the   Emergency  

Departments  with  suspected   fractures   in   their  wrist.  The   inclusion  criteria   for   this  

    57  

study  was  created  using  a  validated  study  conducted  in  Sheffield  Children’s  Hospital  

by  Webster  et  al.   (2006),  who  devised  guidelines   for  when  children  should  receive  

an  X-­‐ray  of  their  wrist  for  a  suspected  fracture.  

 3.7  Population  and  sample    

Over   the   period   of   the   study,   71   children   presented   to   the   emergency  

department   with   painful   wrists   that   met   the   inclusion   criteria.   Over   the   trial  

period   the   researcher   remained   in   the   department   from   0800   to   2200   hours  

every   day.   A   review   of   all   the   notes   of   the   children   attending   the   emergency  

department   during   the   study   period   revealed   that   no   cases   were   missed,  

however   this   number   does   not   include   patients   attending  with   hand,   scaphoid  

and   proximal/mid   shaft   of   radius/ulna   injuries.     Although   this   study   has   been  

designed  as  a  pilot,  therefore  there  is  no  requirement  for  a  power  calculation  to  

be  performed  (Lancaster,  Dodd,  Williamson,  2004,  p.  308),    a  power  calculation  

was   carried   out   based   on   an   audit   of   children   presenting   to   the   emergency  

department   in  August  2007.  This   audit   recorded  76   children  presenting   to   the  

emergency  department  with  painful  wrists,  of  which  39  children  were  reported  

to  have  fractures  of  their  distal  radius  and  ulna.  Based  on  this  audit  a  pre-­‐study  

sample  size  was  calculated,  a  sample  size  of  216  children  was  required  to  ensure  

a   confidence   level   of   95%  was   achieved.     The   pilot   study   was   designed   to   be  

conducted  over  a  four-­‐month  period  within  a  two-­‐year  time  frame,  commencing  

in   April   2008   and   finishing   in   August   2009.   This   was   due   to   the   limited   two  

months   in   one-­‐year   loan   period   of   the   camera.   However,   the   study   was   only  

conducted  over  a  one-­‐month  period  between  the  months  of  May  and  June  2008  

due   to   a   breakage  with   the   camera   and   the   closure   of   the   research   equipment  

loan  facility.    

    58  

 

 3.7.1  Inclusion  criteria:    

1)   Children  between   the  ages  of  0-­‐  15  years   (up   to   the   child’s  16th  birthday)  and  

one  of  the  following:  

2)   Are  complaining  of  or  indicating  pain  in  their  wrist.  

3)   Have  obvious  swelling  and  deformity  of  the  wrist  on  clinical  examination.  

4)   The   child   is   unable   to   supinate   or   pronate   their   wrist   or   has   severe   loss   of  

function.  

3.7.2  Exclusion  criteria:    

The  following  exclusion  criteria  have  been  noted  in  adult  studies  and  are  therefore  

included   here,   however   it   is   not   anticipated   they   will   account   for   large   numbers  

within  the  study  population  (children  under  the  age  of  16).    

1)   Patients   that  have  had   topical   cream  or   cosmetics  applied   to   their  arm  such  as  

fake  tan  etc.  This  can  artificially  affect  the  skin  temperature  and  therefore  skew  

the  test  results  (Engel,  1984,  pp.  177  -­‐184).  

2)   Patients   who   on   questioning   report   that   they   have   smoked.   External  

environmental   factors   such   as   smoking   have   been   shown   to   affect   skin  

temperature  and  therefore  skew  results  (Usuki  et  al.,  1998,  pp.  173-­‐81).  

3.7.3   Ascertainment;  was   the   reference   standard   ascertained   regardless   of   the  diagnostic  test  result.    The   reference   standard   was   maintained   throughout   this   trial   since   all   patients  

presenting  fitting  the  above   inclusion  criteria  had  their  wrist  X-­‐rayed  regardless  of  

the   thermal   imaging   results.   The  methodology   used   provided   the   researcher  with  

enough   data   to   evaluate   the   usefulness   of   thermography   in   the   speciality   of  

paediatric  emergency  medicine.  By  determining  whether  thermography  can  be  used  

    59  

to   rule   out   the   possibility   of   a   fracture   in   a   child’s   limb   certainly   extends   its  

usefulness  as  a  diagnostic  tool  in  a  clinical  setting,  such  as  primary  care,  and  remote  

access  clinics.    

 

3.8  The  Clinical  trial    

Children  who  attended  the  Emergency  Department  in  the  months  of  April  and  May  

2008  with  a  painful  wrist  were  invited  to  take  part  in  this  pilot  study.  The  streaming  

nurse  examined  the  child’s  wrist  and  calculated  their  pain  score  using  the  standard  

pain-­‐scoring   tool   readily   available   in   the   department;   appropriate   analgesia   was  

given  to  the  child  and  the  child  was  then  made  comfortable.  Information  was  given  

to  the  parents  and  child  concerning  the  trial;  if  they  decided  to  take  part  in  the  study  

they  were  given   the  option   to  withdraw   their   consent   at   any   time   (please   refer   to  

appendix   1   for   patient   information   leaflet,   appendix   2   for   consent   form).   The  

complete  flow  diagram  of  the  clinical  trial  is  shown  in  figure  7  on  page  62.      

A  signed  informed  consent/assent  was  obtained  from  the  parent  and  the  child.  The  

child  and  his  family  were  then  asked  to  sit   in  the  playroom,  which  has  a  controlled  

temperature  of  20  –25  ˚C  (Ring  and  Ammer,  2000,  p.  8).    

The  child  was  kept  in  the  playroom  for  15  minutes  so  that  they  became  acclimatised  

to  the  ambient  room  temperature  and  for  their  blood  pressure  and  skin  temperature  

to  stabilise  (Mabuchi  et  al.,  1995).    If  the  temperature  is  colder  than  20  ˚C,  the  child  

will   generate   heat   by   shivering,   if   the   room   is   warmer   than   25˚   C,   the   child   will  

sweat.  Both  of   these  states  will  produce  spurious  findings  and  could   impact  on  the  

clinical   findings.   The   child   was   then   escorted   to   the   x-­‐ray   facility,   were   they  

underwent  the  imaging(  both  x-­‐ray  and  thermal  imaging  )  .  All  measures  were  taken  

to   ensure   that   the   imaging   room  was   a   stable   22°C,   with   diffuse   airflow   to   avoid  

    60  

adverse  temperature  fluctuation  (Ring,  Jones,  Ammer,  Plassmann,  &  Bola,  2004).  

 

The  children  were  positioned  in  either  the  prone  position  or  the  sitting  position  with  

their  arm  supported  on  the  X-­‐ray  plate.  A  FLIR  SC640  thermal  imaging  camera  that  

has  been  specifically  manufactured  for  medical  researchers  was  positioned  over  the  

subject   to   image   each   wrist   separately;   the   wrists   were   positioned   by   the  

radiographer  to  ensure  a  standard  approach  was  used  for  the  positioning  and  image  

capture.  The  thermal  image  was  taken  before  the  X-­‐ray  to  try  to  avoid  excessive  heat  

exchange  between  the  thermal   imaging  operator  and  the  patient.    A  thermal   image  

was   taken   of   both   the   child’s   affected   wrist   and   unaffected   wrist   (the   unaffected  

wrist   provided   the   researcher   with   a   reference   point/further   control).   An  

anterior/posterior  and  lateral  view  by  thermal  imaging  will  be  taken  in  exactly  the  

same  way   as   a   radiograph,   to   ensure   that   the   views   are   taken   in   a   standard  way  

(Ammer  &  Ring,  2004).  If  careful  attention  is  not  paid  to  the  positioning  of  the  wrist,  

individual   measurement   errors   due   to   variations   of   placement   can   take   place  

(Ammer  &  Ring,  2004).  These  variations  can  be  as  be  as  large  as  2˚C  if  not  taken  into  

account,   which   can   alter   the   results   exponentially.   The   image   was   taken   using   a  

standard  approach  described  by  Ring  and  Ammer  (2000).  The  camera  was  mounted  

on  a  stand  and  adjusted  according  to  the  size  and  position  of   the  patient.  Standard  

views   were   taken   at   a   distance   of   50cm,   which   was   measured   using   a   standard  

measuring   stick   before   each   image   was   taken.   The   X-­‐ray   was   then   taken   of   the  

affected  wrist.  The  interpretation  of  the  thermal  image  was  carried  out  after  the  trial  

period  to  ensure  blinding  of  the  results.    The  X-­‐rays  were  interpreted  independently  

of   the   thermal   image   by   the   clinician   caring   for   the   child.   To   ensure   rigor   and  

reliability  of  the  X-­‐ray  results  an  independent  reviewer  examined  the  X-­‐rays  the  next  

    61  

day  independently  of  the  study  (Strauss  et  al.,  2005).    

The  child  was  managed  appropriately  according  to  whether  a  fracture  was  present  

or  not.  The  thermal  image  and  the  X-­‐ray  were  marked  with  the  patient’s  name  and  

district  number  for  identification.  The  details  of  the  child’s  attendance  were  held  on  

the  patient’s  notes  and  a  copy  was  kept  in  a  secure  patient’s  records  facility  for  the  

duration  of  the  study  and  for  up  to  five  years  post  study.      

 

 

 

Figure  7:  Patient  journey  through  department  preceding  trial          

   

 

 

 

 

 

 

X  -­‐  Ray  Interpreted    

Appropriate  treatment  given     Follow  up  arranged  if  necessary    

Asessed  by  clinician    

Clinical  critieria  for  X-­‐ray  met     Patient  sent  to  xray    

Child attends the Emergency Dept with injury to wrist

Triaged  in  the  PED       Pain  score  and  Analgesia  given    

    62  

   

Figure  8:  Flow  chart  of  clinical  trial    

FLOW  CHART  OF  CLINICAL  TRIAL    

 

 

 

 

 

 

   

 

       

 

 

 

 

     

 

     

Child attends the emergency department

With a painful wrist

Assessed by streaming nurse in Paediatric Emergency

department

The child meets the entry requirement for the research study

Informed  consent  obtained  from  parent  and  child  

Child  given  analgesia  and  made  comfortable.  Sat  in  examination  room  for  15  minutes.  Room  is  kept  at  20  –25  °C  

Thermal  image  taken  of  both  wrists    Image  examined  for  evidence  of  exothermic  reaction  in  

affected  wrist    

X-­‐ray  taken  in  X-­‐  ray  department    Independently  reported  the  next  day    

Child  receives  the  appropriate  treatment    and  follow  up  dependent  on  X-­‐ray  findings  

    63  

     3.9  Data  Collection    

A  data  collection  tool  captured  both  the  epidemiological  and  clinical  data  of  the  child  

presenting  with  a  painful  wrist   (refer   to  appendix  3).  The  ambient   temperature  of  

the   imaging   room   was   recorded   along   with   the   clinical   data   regarding   the  

temperature  recording  for  both  the  injured  and  the  uninjured  wrist  as  recorded  by  

the  thermal  imaging  camera.    A  copy  of  the  data  collection  tool  was  inserted  into  the  

patient’s   notes   and   a   copy   used   for   data   collection   by   the   principal   researcher.  

Inclusion  criteria  were  included  on  the  tool  as  well  as  presenting  complaint,  history,  

and  examination  findings.  The  ethics  committee  stipulated  that  the  results  of  the  X-­‐

ray  were  not   to  be   recorded  on   the  data   collection   tool   for   six  months  post   initial  

presentation   to   reduce   interpreter   bias.   This  meant   that   no   data   comparison  was  

made   for   six  months   post   study.   The   patient   data   has   been   stored   securely   in   the  

patient’s  records  storage  facility  in  the  usual  manner.  

3.10  Analysis  of  the  data    

The  statistician  from  the  University  of  Portsmouth  advised  the  researcher  on  the  

appropriate  statistical  tools  and  parametric  tests  to  be  used  for  this  study.  SPSS  

21   and  Graph   pad,   Prism   6   (2013)   advanced   research   analysis   software   were  

used   to   analyse   the   data   for   this   study,   as   advised   by   the  medical   statisticians  

from   the   University   of   Portsmouth   and   the   University   of   Southampton.   The  

initial   analysis   of   the   data   was   to   determine   whether   there   was   a   significant  

temperature   difference   between   the   injured   wrists   (test   group)   versus   the  

uninjured  wrist  (control  group).  Once  this  was  determined  further  data  analysis  

was   carried   out   by   dividing   the   test   groups   into   two   groups.   Those   with   a  

    64  

fracture   determined   by   X-­‐ray   were   measured   against   the   control   (uninjured  

limb),  while  those  with  proven  soft  tissue  injury  were  also  measured  against  the  

control   (uninjured   limb).   Once   the   data  was   analysed   and   calculated   for   these  

groups,   the   two   groups’  means  were   compared   using   an   independent   t-­‐test   to  

determine  the  difference  between  the  control  and  the  test  group  means  (Polit  et  

al.,  2001,  p.  473).  The  reference  standard  to  determine  the  difference  between  a  

fracture  and  a  soft  tissue  injury  was  set  at  a  difference  of  greater  than  1˚  C  (Hosie  

et   al.,   1987,   pp.   117-­‐20).     This   was   to   ensure   that   the   thermal   image   could  

differentiate  between  a   fracture  and  a   soft   tissue   injury.  The  results  have  been  

presented  in  table,  bar  graph  and  text  for  the  main  study  group  (fracture  group),  

whereas   for   group   two   the   comparison   group   has   been   presented   in   a   table  

comparing   the   two   arms   of   the   study,   examining   the   difference   between   the  

control  group  against  the  soft  tissue/no  fracture  noted  group.      

An  independent  t-­‐test  has  been  used  to  compare  the  two  test  groups  with  their  

control.  This   is   a  parametric   test  designed   to   compare   the   two  means  of  a   test  

group   in   this   study,   comparing   the   injured   arm   versus   the   uninjured   arm  

(control),   and   then   the   soft   tissue   injured   limb   against   the   fractured   limb.   The  

standard   approach   to   determine   the   accuracy   of   a   diagnostic   tool   is   to  

investigate   their   sensitivity   or   specificity   (Dawes   et   al.,   2005,   p.   155).   The  

sensitivity   examines   whether   the   diagnostic   test   can   detect   subjects   with   a  

particular   disease,   in   the   case   of   this   study   whether   the   thermal   imaging   is  

sufficiently   sensitive   and   specific   to   detect   the   exothermic   reaction   that   may  

signify  a  break  in  the  cortex  of  the  ulna  or  radius.  Thus  a  high  sensitivity  suggests  

that   if   an  exothermic   reaction   is  present   then   the  patient  does  have  a   fracture.  

The  specificity  examines  whether  a  certain  test  can  rule  out  a  disorder,  therefore  

    65  

if  no  exothermic  reaction  is  detected,  can  this  test  positively  rule  out  a  fracture.  

As  yet  no  body  temperature  atlas  or  reference  data  is  available  to  formulate  the  

normal   range,   therefore   the   reference   intervals  was   taken   from   the  unaffected  

limb.  

No  study  determining  whether  thermal  images  could  be  used  to  detect  fractures  in  

children   have   been   conducted   previously,   which   meant   that   the   researcher   was  

unable   to  determine   the   standard  deviation  of   the  mean   temperature  of   a  normal,  

unaffected  limb.  Therefore  for  this  pilot  study  the  standard  deviation  was  calculated  

by  the  data  produced  from  the  control  arm,  to  determine  what  would  constitute  an  

abnormal  rise   in   temperature  thus  suggesting  an  exothermic  reaction,  which  could  

signify   a   fracture.   The   investigator   examined   the   incidence   of   false   positives   and  

false  negatives  amongst  the  gold  standard,  thus  determining  the  reliability  of  either  

diagnostic  tool.  Frequency  tables  were  used  to  report  the  results  and  determine  the  

positive  and  negative  predictive  values   for  each  of   the  diagnostic   tools  used.  Given  

this  data  likelihood  ratios  were  calculated  to  determine  whether  the  positive  result  

occurred  by  chance.  A  high  likelihood  ratio  for  a  positive  result  suggests  that  the  test  

provides  useful   information,   as  does   a   likelihood   ratio   close   to   zero   for   a  negative  

result  (Petrie  &  Sabin,  2005,  p.  103).  

3.11  Ethical  issues    

This  research  protocol  has  been  devised  using  the  four  ethical  principles  described  

by  Beauchamp  and  Childress  (1989):    

• Respect  for  autonomy    

• Beneficence  

• Non  Maleficence    

    66  

• Justice    

3.11.1  Respect  for  autonomy    

Full   consent   was   obtained   from   the   subjects   invited   to   take   part   in   this   research  

project.   The   information   regarding   this   research   was   discussed   in   full   and   the  

participants  were  able  to  withdraw  consent  at  any  time.  Where  children  were  judged  

to   be   too   young   to   understand   and   give   full   assent,   the   parents   were   asked   to  

provide  consent   for   their   child   in  accordance   to   the  safeguarding  children’s   report  

(2005).  The  consent  form  (refer  to  appendix  II)  and  patient  information  leaflet  had  

been   devised   in   liaison  with   the   Patient,   Advice   Liaison   Service   (PALS)  within   the  

hospital  where  the  trial  was  conducted.  The  consent  form  has  been  adapted  for  this  

project   from  MREC  2007  guidance  document.  At  all   times  the  patient’s  rights  were  

taken  into  consideration  and  the  Human  Rights  Act  adhered  to  at  all  times.  Although  

Pence  (1990,  p.  26)  recommends  that  patients  should  be  given  24  hours  to  reflect  on  

the  information  given  and  then  decided  to  enroll  or  not,  this  was  not  possible  for  this  

research  project.  However,  the  parent  and  child  were  given  adequate  time  to  reflect  

and  ask  relevant  questions,  parent  and  the  child  could  withdraw  from  this  study  at  

any  point  and,  in  this  case,  any  pictures  and  data  collected  would  be  destroyed.      

 

3.11.2  Beneficence  and  Non-­‐maleficence  

Following  the  literature  search  described  above  the  principal  researcher  could  find  

no   evidence   of   any   sequelae   or   harmful   effects   observed   after   having   a   thermal  

image  taken.  No  child  received  a  radiograph  unless  they  met  the  inclusion  criteria  as  

described  above.  There  is  an  obligation  to  maximise  the  benefits  to  the  patient  and  

minimise   the   harm   (Crooke   &   Davies,   1998,   p.   214).   At   no   time   was   the   child’s  

treatment  or   investigations  delayed  by   this   research  project,   the  project   improved  

    67  

the  care  given  to  children  with  fractures  to  their  forearm  as  it  ensured  that  the  strict  

timelines  prescribed  within  this  project  were  adhered  to.  If  the  child  got  distressed  

at  any  stage  of  the  research  procedure  they  were  immediately  withdrawn  from  the  

research  project.  A  play  specialist  was  available  to  comfort  the  child  and  care  for  the  

child’s   psychological   needs.   The   principal   researcher   was   available   at   all   times  

throughout  this  research  project  to  answer  any  questions  or  queries  that  the  patient  

or  parent  had.  No  image  of  the  child  was  kept  on  a  public  database  at  any  time;  it  has  

been   stored   on   hospital   password   protected   computer   file.   No   identifying   images  

were  taken  of  the  child  and  the  parent  and  child  were  shown  every  picture  taken.  All  

possible  measures  were   taken   to   protect   the   child   and   their   families’   identity.   All  

pictures   used   in   subsequent   publications   regarding   this   research   project   will   be  

made  anonymous  and  the  child’s  identity  withheld.    

3.11.3  Justice    

Crookes   and  Davies   (1998)   suggest   this   refers   to   the   researcher   ensuring   that   the  

benefits   and   burdens   of   participation   are   equally   distributed   across   the   sample  

group.   The   principal   researcher   ensured   that   throughout   the   research   project   all  

children   enrolled   into   this   trial  were  managed   and   cared   for   in   accordance   to   the  

research  protocol  outlined  above.  No  child  received  care  outside  the  parameters  of  

the   research   project.   All   the   children   enrolled   into   this   project   were   managed  

according   to   best   practice.   To   ensure   that   sample   bias   is   reduced   the   ethics  

committee   stipulated   that   the   results   from   the   thermal   imaging   should   be   kept  

separate   from   the   results   of   the   X-­‐rays   and   that   the   analysis   should   take   place   at  

least  six  month  post  study.    

Ethics   approval   was   granted   by   the   National   Research   and   Ethics   Service  

Southampton   &   South  West   Hampshire   Research   Ethics   committee   in   full   on   18th  

    68  

March   2008,   without   any   amendments   or   conditions   imposed.   The   study   was  

granted   permission   to   proceed   by   the   Portsmouth   NHS   R&D   consortium   on   28th  

March  2008  (refer  to  Appendix  4).    

 

                                               

    69  

 

Chapter  4  

 

 

 

 

 

 

 

 

 

 

   

 

 

 

    70  

Chapter  4  Data  analysis  and  results    

4.1  Introduction    

 This  chapter  will  present  the  findings  of  the  study  using  the  data  collected  over  

the  study  period.  The  data  was  collected  in  a  quantitative  form  over  a  one-­‐month  

period.  However,to  reduce  test  review  bias,  or  the  Hawthorne  effect  (Knottnerus,  

2002),  the  data  was  not  analysed  until  six  months  post  study  period,  as  directed  

by   the   ethics   committee.   The   data   has   been   presented   from   both   the   control  

group   (uninjured  wrist)   and   the   test   group   (injured   limb)   of   the   overall   study  

participants.  This  chapter  will  compare  the  results  of  the  control  group  and  test  

group   as   well   as   subdividing   the   findings   into   a   fracture   positive   group  

(confirmed   by   X-­‐ray)   and   soft   tissue   injury   group.   The   data   from   the   fracture  

group   has   been   presented   on   individual   test   sheets   describing   the   individual  

thermal   imaging   results   from  each   subject   and   in   spread   sheets  describing   the  

whole  test  series  (Appendix  3).    The  data  was  collated  and  stored  using  advanced  

spreadsheet  in  Microsoft  office  2008©.    Once  the  data  had  been  collected  it  was  

cleaned,   checked   for   accuracy   of   translation   and   any   missing   data   identified  

(Bowling,  2009).    The  data  was  analysed  using  statistical  packages  SPSS  21  and  

graph  pad  prism  6,   (2013)  as  advised  by   the  University  of  Portsmouth  and   the  

University  of  Southampton  medical  statisticians.  

4.2  Demographic  data  

Overall  71  children  were  entered  into  this  study.  Two  patients  were  withdrawn  

from  the  trial  due  to  the  distress  caused  by  the  significance  of  their  fracture  and  

two   patients   were   excluded   in   the   initial   stages   of   the   pilot   due   to   set   up  

    71  

complications  and   loss  of  data,  meaning   that  67  children  were   included   in   this  

studies  results.    

Fig  9:  Flow  Diagram:  Patients  enrolled  into  the      pilot  study      

 

 

 

 

 

 

 

 

 

 

 

 

 

   

 

 

 

 

 

 

 

Assessed for eligibility (n= 71)

Excluded (n= 4) ♦      Declined to participate (n= 2) ♦      Other reasons (n= 2)

Fracture group compared with control Analysed (n= 34) ♦  fractures diagnosed on x ray  

Discontinued intervention (n=2) due to lost data on camera thus excluded from trial

Allocated to intervention (n= 69) ♦  Received allocated intervention underwent

thermal imaging and X-rays (n= 67)  

Injured group (non – fractured) compared with control: Analysed (n= 33) ♦  no  fracture  found  on  x-­‐ray      

Analysis  

Randomised (n= 0)

Injured wrist compared with control: Analysed (n=67)    

    72  

                 

Table  4.1  Demographic  data              The  mean  age  of  the  children  enrolled  onto  the  study  was  9.5  years  of  age  with  

the  majority  of   the  children  being  boys.  The  youngest  child  was  18  months  old  

with   the   oldest   being   15   yrs.   Overall   44  male   subjects   and   23   female   subjects  

were  enrolled  in  the  study.  

 4.2.1  Results  from  the  Data  collection  forms    

The  interrogation  of  the  data  collection  forms  shows  that,  out  of  the  67  children  

enrolled  onto  this  study,  34  patients  had  fractures  confirmed  by  X-­‐ray.    Of  these  

fractures:  11  were  buckle  fractures,  18  were  green  stick  fractures  with  ulna  and  

radius   involvement   and   5  were   reported   as   transverse   fractures  with   a   Salter  

Harris  deformity  reported.  There  were   three   fractures  not  detected  by   thermal  

imaging  (not  recording  a  temperature  rise  greater  than  1°C  when  compared  with  

the  control).  Two  of  these  fractures  were  reported  to  have  gross  deformity  with  

very  obvious  clinical  signs  and  one  was  reported  to  have  minimal  deformity  with  

reasonable   range  of  movement.  This   fracture  would  have  been  missed   if   solely  

dependent  on  thermal  imaging  recordings.  A  breakdown  of  the  individual  results  

can   be   seen   in   Tables   4.2   and   4.3,   which   summarises   the   clinical,   and  

demographic  data  collated  this  study.  

 

Age   of  

subjects  

(yrs)  

Mean  

Age  (yrs.)    

Range:  

1-­‐5  (yrs.)  

 

6-­‐10  

(yrs.)  

 

11-­‐15  

(yrs.)  

Gender  

M                F  

No  67     9.4     7   24   36   44   23  

    73  

 

Table  4.2  Summary  of  the  clinical  and  demographic  data  from  study  data  collection  forms:  Children  with  fractures.        Age     Gender     Fracture     Type  of  fracture   Clinical  deformity     Pain  

score    10   M   Yes   Buckle     Minimal     8  7   M   Yes   Buckle     None   6  8   F   Yes   Green  stick     None     2  12   M   Yes   Buckle     None     7  11   M   Yes   Buckle     None     3  6   F   Yes   Green  stick     Minimal     2  7   F   Yes   Green  stick     Gross     4  11   M   Yes   Fracture  

Transverse    Gross     10  

11   M   Yes   Green  stick     Minimal     6  13   M   Yes   Green  stick     Minimal     8  8   M   Yes   Green  stick     Minimal     6  14   M   Yes   Buckle  /  

greenstick  Minimal  /  SH1   2  

14   F   Yes   Buckle     Minimal     3  5   F   Yes   Off  ended  /SH2   Gross   9  6   M   Yes   Green  stick     Minimal     6  11   M   Yes   Green  stick     Minimal     2  15   F   Yes   Green  stick     Minimal     6  8   M   Yes   Green  stick     Minimal     6  15   F   Yes   Salter  Harris  4   Gross   3  6   M   Yes   Off  ended     Gross   2  7   F   Yes   Green  stick     Minimal     2  11   M   Yes   Green  stick     Minimal     7  13   M   Yes   Green  stick     Gross   3  14   M   Yes   Green  stick     Gross   10  12   M   Yes   Green  stick     Minimal     6  10   M   Yes   Buckle     None   6  13   M   Yes   Buckle     None   6  10   F   Yes   Buckle  /  

greenstick  Minimal     6  

13   M   Yes   Green  stick     Minimal     6  11   M   Yes   Buckle     None   7  4   M   Yes   Buckle     None   5  7   M   Yes   Green  stick     Minimal     6  14   M   Yes   Green  stick     Gross   6  10   M   Yes   Buckle     Minimal     7  

 

    74  

Table  4.3  Summary  of  the  clinical  and  demographic  data  from  study  data  collection  forms:  Children  without  fractures.    (Soft  tissue  injury)        Age     Gender     Fracture     Type  of  fracture   Clinical  deformity     Pain  

score    6   M   NO   NO   Minimal     6  9   F   NO   NO   Minimal     6  14   F   NO   NO   Minimal     8  10   M   NO   NO   Minimal     10  11   F   NO   NO   Minimal     2  11   M   NO   NO   Minimal     2  14   M   NO   NO   Minimal     1  11   F   NO   NO   Minimal     2  13   M   NO   NO   Minimal     2  13   F   NO   NO   None   2  10   M   NO   NO   Minimal     2  8   M   NO   NO   None   2  13   F   NO   NO   Minimal     6  6   M   NO   NO   Minimal     6  13   F   NO   NO   None   6  14   M   NO   NO   None   2  9   F   NO   NO   None   2  12   M   NO   NO   None   2  11   F   NO   NO   None   3  8   M   NO   NO   None   2  4   M   NO   NO   None   1  8   F   NO   NO   None   2  3   M   NO   NO   None   3  1   M   NO   NO   None   2  9   F   NO   NO   None   8  15   M   NO   NO   None   8  15   F   NO   NO   Minimal     6  4   M   NO   NO   Minimal     2  8   F   NO   NO   None   2  6   M   NO   NO   None   5  14   M   NO   NO   Minimal     2  13   F   NO   NO   None   2  1   M   ?  But  

reported  NBI  

NO   None   2  

 

   

    75  

4.2.2:  Inclusion  criteria  met    

Table  4.4  inclusion  criteria      

                               

   The   above   table   (Table   4.4)   shows   the   inclusion   criteria   for   the   children  

presenting   to   the   emergency  department  with   an   injury   to   their  wrist.   Each  of  

the  children  presenting  to  the  department  complained  of  pain  in  their  wrist  and  

the   pain   score   recorded   on   the   data   sheet   at   nurse   streaming   confirmed   this.    

Forty-­‐four  children  had  obvious  deformity  or  swelling  reported   to   their  wrists,  

on   examination   of   the   child’s   clinical   records   57   were   unable   to  

pronate/supinate   their  wrist   and   46   children   reported   some   degree   of   loss   of  

function  on  clinical  examination.    

4.3  Results  from  thermal  imaging  data    

Table  4.5  shows  the  data  collected  from  all  of  the  participants  enrolled  onto  the  

study.  The  table  below  details  the  mean  temperature  recorded  from  the  thermal  

image   using   the   temperature   analysis   software   FLIR   researcher   Pro   2.10   (Flir,  

2008)   for   thermal   imaging   research.     The   table   shows   the   differences   in   the  

mean   temperatures   taken   from   the  anterior  posterior  view  and   lateral   view  of  

Children  the  age  of  0-­‐15years  (up  to  their  16th  birthday)   Total      67  

Complaining  of  or  indicating  pain  in  their  wrist     67  

Obvious  swelling  or  deformity  of  the  wrist  on  clinical  examination     44  

Child  is  unable  to  supinate  or  pronate  their  wrist     57  

Have  severe  loss  of  function  on  clinical  examination     46  

    76  

the   thermal   imaging   camera.   The   table   below   also   shows   the   temperature  

recorded   using   the   thermal   imaging   camera   for   both   the   injured   limb   (study  

group)   when   compared   to   the   opposite   uninjured   limb   (control).   The   third  

column  of   the   table   shows   the  variance  of   temperatures   recorded  between   the  

injured  limb  (study  group)  and  the  uninjured  limb  (control).    

Table  4.5  Study  group  versus  control  (uninjured  limb)      

 Thermal  imaging  data  :    

       

Control  (°C)     Study  group  (°C)   Variance  (°C)      

34.5   35.5   1  

34.9   36.05   1.15  

33.1   34.5   1.45  34.8   35.9   1.1  34.8   35.8   1  34.6   36.1   1.5  34.2   35.3   1.2  33.1   34.5   1.4  33.1   35   1.8  33.6   35.7   2.1  34.4   35.1   1.1  34.9   36.1   1.2  33.2   34.5   1.3  36.4   37.1   0.65  34.4   35.4   1  34.6   35.6   1.15  34.8   36.4   1.5  34.8   36   1.2  33.5   33.5   0  32.8   36   3.1  33.2   35.2   2  34.4   34.5   0.1  34.5   35.5   1  33   34.4   1.3  35.5   36.5   1  34.6   35.4   1  34.7   36.5   1.3  34.6   35.7   1.1  

           

    77  

Control  (°C)        

Study  group  (°C)   Variance  (°C)  

35   36.3   1.3  33.1   34.2   1  34.3   35.9   1.6  34.8   36.4   1.5  34.8   36   1.2  33.7   35.5   1.8  34.75   34.7   0.05  34.35   34.2   0.2  

34.9   35.35   0.6  

34.1   35   0.9  34.9   35.2   0.3  35   35   0.4  34.45   35.15   0.7  31.25   33.25   2  35   35.6   0.6  35.05   35.5   0.4  35.35   35.95   0.6  35.35   36   0.65  33.85   34.25   0.4  35.7   35.25   0.25  34.2   34.4   0.2  34.5   34.5   0  35.45   35.9   0.45  34.4   34.4   0  33.55   33.55   0  33.5   33.7   0.2  32.75   32.75   0  33.45   34.65   1.2  32.8   33.1   0.3  33.5   33.55   0.05  32.55   33.15   0.6  33.7   33.85   0.15  31.8   33.9   2.1  33.4   34.35   0.9  29.8   31.45   1.6  31.5   32.8   1.3  35.25   35.5   0.25  35.3   35.35   0.05  34.4   35.3   0.95    

 

 

    78  

Table  4.6:  Summary  of  results;  Study  Group  vs.  Control  (uninjured  limb)    Condition     Number   Mean     Std  deviation     Std  Error  of  Mean     Significance    

Fractures    

Control      

67  

67  

34.99°C  

34.09°C  

1.084  

1.149  

0.132  

0.1404  

 

P<0.0001  

 

Higher  mean  temperatures  were  recorded  in  the  study  group  (mean  =  34.99°C)  

when  compared  to  those  of  the  control  group  (34.09°C).  A  paired  sample  T-­‐test  

showed   that   the   difference   between   the   two   groups   were   statistically  

significant   (T   =10.14,df=66,p   <0.0001),   two   tailed).   The   magnitude   of   the  

difference   in   the  means   (mean  difference  0.90°C,   95%  CI:   0.72   to  1.079)  was  

significant  enough  to  suggest  that  a  pathological  change  had  taken  place  (SD  of  

difference  =  0.72:  SEM  of  difference  =  0.088).  The  results   in   table  4.5  suggest  

that   thermal   imaging   may   demonstrate   the   ability   to   detect   changes   in  

temperature  due  to  traumatic  injury  in  children’s  wrists.    

 

 

 

 

 

 

 

 

 

 

 

    79  

4.4  Study  Group  :  fractured  wrist  compared  with  injured  non-­‐fractured  group.    

Table  4.7  Comparison  of  the  fracture  group  with  the  injured  non  fractured  group.    Children  with  Fractures  compared  injured  non  fracture    

 Fractured  (°C)  (Study  group,  n=34)  

Non   –   fractured   (°C)  (Study  group,  n=33)        

  35.5   34.7         36   34.2         36.4   35.35         35.4   35         35.95   35.2         34.1   35.0         36.3   35.15         35.7   33.25         36.05   35.6         36.49   35.5         34.4   35.95         35.5   36         34.5   34.25         35.2   35.25         36   34.4         33.5   34.5         36.05   35.9         36.4   34.4         35.7   33.55         35.49   33.7         37.1   32.75         34.4   34.65         36.1   33.1         35.1   33.55         35.75   33.15         35   33.85         34.56   33.9         35.3   34.35         36.1   31.45         35.8   32.8         35.9   35.5         34.55   35.35         36.05   35.4         35.5                            

 

 

 

   

 

    80  

Table  4.8:  Summary  of  independent  T-­‐test  results:    fractured  wrist  study  group  compared  with  injured  non-­‐fractured  study  group    Condition     Number   Mean     Std  deviation     Std   Error   of  

Mean    

Significance    

Fractures    Non  Fractured    Study  group  

34  33  

35.52°C  34.44°C  

0.793  1.086  

0.1361  0.1891  

P  <  0.0001  

 

Table  4.7  demonstrates  the  difference  in  degrees  centigrade  between  the  injury  

groups.   The   table   shows   the   results   from   the   wrists   that   were   fractured  

according   to   their   X-­‐ray   results   (N=   34)   compared   with   those   who   had   no  

fracture  reported  on  X-­‐ray  (N  =  33).  The  fracture  group  records  a  higher  mean  

temperature   (Mean   =   35.52˚C)   when   compared   to   the   non-­‐fractured   group  

(injury   group)     (Mean   =   34.44˚C).   An   independent   T-­‐test   showed   that   the  

difference   between   fracture   and   the   soft   tissue   injury   group   was   statistically  

significantly  different  (t  =  4.704,df  =  65,  p  <0.0001two  tailed).  The  difference  in  

the  means   between   the   two   groups   (mean   difference   1.084   95%   CI   =   0.62   to  

1.54)  was  large.  The  sample  mean  for  the  fracture  group  is  35.52  and  the  sample  

shows  that  we  can  be  95%  confident   that   the  population   falls  between  35.25˚C  

and  35.80˚C.  The  sample  mean   for   the  non-­‐fracture  group  was  34.44˚C  and  the  

sample   shows   that  we  can  be  95%  confident   that   the  population   falls  between  

34.06˚C   and   34.83˚C.   This   suggests   that   the   difference   between   the   fracture  

group  and  the  non-­‐fractured  injury  group  is  quantifiable  and  therefore  suggests  

that   thermal   imaging   may   be   useful   in   determining   the   difference   between   a  

fracture  and  a  non-­‐fracture  when  comparing  recorded  mean  temperatures.    

 

    81  

4.5  Fracture  group  compared  with  control  (Unijured  limb)  

Table  4.9  Children  with  Fractures  compared  with  the  control  (Uninjured  limb)    Children   with   Fractures   compared   with   the   control  (Uninjured  limb)  N=34  

 Fracture  (°C)   Control  (°C)     Variance  

  35.5   33.7     1.8     36   34.8     1.2     36.4   34.8     1.6     35.4   34.4     1     35.95   34.3     1.6     34.1   33.1     1     36.3   35     1.3     35.7   34.6     1.15     36.05   34.75     1.3     36.49   35.5     1     34.4   33.05     1.3     35.5   34.5     1.05     34.5   34.4     0.15     35.2   33.2     2     36   32.2     3.9     33.5   33.5     0     36.05   34.8     1.2     36.4   34.85     1.55     35.7   34.6     1.15     35.49   34.5     1     37.1   36.4     0.65     34.4   33.2     1.3     36.1   34.9     1.2     35.1   34.4     1.1     35.75   33.6     2.1     35   33.1     1.9     34.56   33.15     1.4     35.3   34.     1.2     36.1   34.6     1.5     35.8   34.8     1     35.9   34.8     1.1     34.55   33.1     1.45     36.05   34.9     1.15     35.5   34.5     1                      

 

 

 

 

    82  

Table  4.10:  Summary  of  results  from  comparison  of  fracture  group  vs.  control  (Uninjured  Limb)    Condition     Number     Mean     Std   deviation   of  

differences    

Std   Error   Mean  

of  differences    

Significance    

Fracture    

Control    

34  

34  

35.52°C  

34.24°C  

0.7827  

0.8653  

0.1342  

0.1484  

P<0.0001  

 

The   comparison   between   the   fracture   group   (diagnosed   by   X-­‐ray)   and   the  

control   group   (uninjured   wrist)   are   shown   in   Table   4.9.   A   higher   mean  

temperature  was  recorded  in  the  fracture  group  (mean  =  35.52,  95%  CI  35.25  to  

35.80)   than   in   the   non-­‐injured   control   arm   (mean   =   34.24   95%   CI   33.93   to  

34.54).  A  paired  T-­‐test  showed  that  the  difference  between  the  two  groups  were  

statistically   significant   (t   =   6.44,df=66,p<.   0001,   two   tailed)   the   size   of   the  

difference   in   the   means   (mean   difference   =   1.28,   95%CI   0.889   to   1.689)   is  

considered  clinically  and  statistically  significant   (p<.  0001).  The  mean  variance  

between   the   two   groups  was   1.28˚C  which   suggests   that   the   hypothesis   that   a  

fracture   has   a   greater   than   1˚C   temperature   gradient,   when   compared   to   a  

control   (uninjured   arm),   was   accurate.   Based   on   the   temperature   recordings  

taken   from   the   individual   subject   groups,   three   fractures   were   missed   by   the  

thermal   reading   taken.   Two   of   these   fractures   were   clinically   obvious   on  

examination  with  gross  deformity  noted  of  the  exterior  anatomy  of  the  wrist  and  

an  X-­‐ray  would  have  been  requested  on  clinical  examination.  A  buckle  fracture  of  

a   14-­‐year-­‐old   boy   would   have   been   missed   both   clinically   and   on   thermal  

imaging,  which  was  captured  by  X-­‐ray.    

 

 

    83  

4.6  Non  fractured  injury  group  compared  with  control  (Unijured  limb)  

 

Table  4.11:  Non-­‐fractured  injury  group  vs.  control  (Uninjured  limb)          

   

         

 

Non   fractured  study   group  n=33  

Control   (°C)  n=33   Variance  

  34.7   34.75   0.05     34.2   34.3   0.1     35.35   34.9   0.6     35   34.1   0.9     35.2   34.9   0.3     35.0   35   0.4     35.15   34.45   0.7     33.25   31.25   2     35.6   35   0.6     35.5   35.05   0.4     35.95   35.35   0.6     36   35.35   0.65     34.25   33.85   0.4     35.25   35.7   0.25     34.4   34.2   0.2     34.5   34.5   0     35.9   35.45   0.45     34.4   34.4   0     33.55   33.55   0     33.7   33.5   0.2     32.75   32.75   0     34.65   33.45   1.2     33.1   32.8   0.3     33.55   33.5   0.05     33.15   32.55   0.6     33.85   33.7   0.15     33.9   31.8   2.1     34.35   33.4   0.9     31.45   29.8   1.6     32.8   31.5   1.3     35.5   35.25   0.25     35.35   35.3   0.05     35.4   34.45   0.45  

   

    84  

Table:  4  12  Summary  of  paired  T  –test  results:  non  fractured  injury  group  vs.  control  (Uninjured  limb)    Condition     Number   of  

patients    

Mean     Std   deviation   of  

difference    

Std   Error   Mean  

of  difference    

Significance    

Injury  group  NF  

Control    

33  

33  

34.44    

33.93  

1.83  

1.379  

0.1886  

0.2400  

P<0.0001  

 

Table   4.12   compares   the   results   of   the   non-­‐fractured   injury   group   with   the  

control   (uninjured  arm).  Higher  mean  temperatures  were  recorded   in   the  non-­‐

fractured   injury   group   (Mean=34.44˚C)   than   in   the   control   group  

(mean=33.93˚C).   A   paired   T-­‐test   showed   that   the   difference   between   the   two  

groups  was   statistically   significant   (t   =4.8396,df=  32,   p  <0.0001,   two   tailed).  A  

mean   temperature   variance   of   0.507   centigrade   was   recorded   between   the  

injured  non-­‐fractured  group  and  their  control  (95%  CI:  0.2939to  0.7213).    Four  

subjects   with   soft   tissue   injuries   had   temperatures   differences   recorded   over  

1.0˚C   when   compared   to   their   control,   which   means   that   they   would   have  

received  an  X-­‐ray  when  no  fracture  was  observed  either  by  the  initial  clinician  or  

consultant  radiologist.    

 

 

 

 

 

 

 

 

    85  

4.7  Sensitivity  and  specificity      

Table  4.13  Fractures  compared  with  no  fractures:  Sensitivity  and  specificity  of  thermal  imaging  when  compared  with  radiographs         Fracture     No  

fracture    Totals      

Test  positive     31   4   35   Positive  predictive  value  

88.57%  

Test  negative     3   29   32   Negative  predictive  value  

90.32%  

Totals     34   33   67   Prevalence     50.75              Sensitivity   91.18%   (76-­‐98)        Specificity     87.88%   (71-­‐96)          Table   4.13   shows   the   sensitivity   and   specificity   findings   demonstrating   the  

ability   of   thermal   imaging   to  detect   fractures   in   children  when   compared  with  

the  gold  standard  of  X-­‐ray.  When  compared  with  radiographs,  thermal  imaging  is  

91.18  %  likely  to  correctly  diagnose  a  fracture  in  a  child  with  injury  to  the  wrist  

and   is   87.85%   accurate   in   ruling   out   a   fracture;   the   sensitivity   is   increased   to  

96.7  %  when   the   clinical   examination   is   taken   into   account.   During   the   study  

only  one  fracture  would  have  been  missed  if  the  physical  examination  were  used  

within  the  results  findings  instead  of  the  thermal  image  being  used  in  isolation.    

4.8  Likelihood  Ratio  

A  likelihood  calculation  was  carried  out  to  determine  whether  the  positive  result  

has   occurred   due   to   chance   rather   than   by   the   diagnostic   tool   itself.   The  

likelihood  ratio  for  a  test  result  is  defined  as  the  ratio  between  the  probability  of  

observing  that  result  in  patients  with  the  disease  in  question,  and  the  probability  

of  that  result  in  patients  without  the  disease  (Akobeng,  2006,  p.  487).  

Likelihood   ratios  are   clinically,  more  useful   than   sensitivity  and   specificity  and  

are   becoming   the   most   popular   and   accurate   test   when   reporting   diagnostic  

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research  (Deeks,  2004,  p.  169).  A  likelihood  ratio  greater  than  1  indicates  the  test  

result  is  associated  with  the  disease,  a  likelihood  ratio  less  than  1  indicates  that  

the  result  is  associated  with  absence  of  the  disease.  

Table  4  .14  Likelihood  Ratios      

Likelihood  ratio  positive  result    

7.52   (2.98-­‐18.95)  

Likelihood  ratio  negative  result    

.10   (0.03-­‐0.31)  

 

In  this  study  the   likelihood  ratio  for  the  positive  test  was  calculated  to  be  7.52.  

This  means   that  a   child  with  a   temperature   recording  equal   to  or  greater   than  

1°C  in  their  injured  wrist  is  7.5  times  more  likely  to  have  a  fracture  than  not  have  

a  fracture.  

This  suggests   that   it   is  highly  probable   that   thermal   imaging   is  able   to  detect  a  

fracture  in  children  rather  than  it  just  being  by  chance.    The  negative  likelihood  

ratio  was  calculated  to  be  0.1,  which  means  the  probability  of  having  a  negative  

test   for   individuals   with   a   fracture   is   0.10   times   of   that   of   those   without   the  

fracture.  This  suggests  that  children  without   fractures  are  10  times  more   likely  

to  have  a  negative  test  result  than  those  who  have  a  fracture.   Jaescheke,  Guyatt  

and  Limer  (2002,  p.  123)  suggest   that  having  a  negative   likelihood  ratio  below  

0.1  virtually   rules  out   the   chance   that   a  person  has   the  disease.  The   likelihood  

ratio   conducted   for   this   study   showed   very   positive   results   suggesting   that  

thermographs  can  be  used  to  detect  fracture  in  children.    

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The  results  from  this  study  suggest  that  there  is  a  significant  difference  between  

the  control  and  the  test  groups.  The  results  described  in  this  chapter  suggest  that  

thermal   imaging  may   be   useful   in   detecting   differences   in   pathology   following  

injury   in   children’s   limbs.  The   results  highlight  a  mean  difference  of  1.28˚C   (t=  

6.44,df   =66,p=.   0001)   when   a   fracture   is   present   in   a   child’s   wrist   and   mean  

difference  of  .50˚C  when  associated  with  a  soft  tissue  injury  when  compared  with  

the  control.  The  likelihood  ratio  adds  further  weight  to  this  argument  as  does  the  

sensitivity  and  specificity  related  to  this  test.  The  fact  that  such  highly  significant  

results  were  found  with  a  comparatively  small  sample  size  adds  further  weight  

to   the  study’s   findings  (Guiffre,  1994).  Further  discussion  and  analysis  of   these  

results  and  their   implication  to  practice  are  discussed   in  detail   in  the  following  

chapter.    

4.9  Summary    

This   chapter   has   highlighted   the   findings   from   this   study,   detailing   the   clinical  

variance  and  the  data  collected  throughout  the  study  time  frame.  The  data  from  

this   study   has   been   collated   in   tabular   form   and   evaluated   using   statistical  

packages   SPSS   21   and   graph   pad   prism   6,   (2013).     The   overall   findings   have  

concluded  that  thermal  imaging  can  detect  a  temperature  rise  of  greater  than  1˚C  

in   children   with   a   fracture   when   compared   with   a   non-­‐injured   arm   in   the  

majority   of   cases.   However,   the   thermal   imaging   camera   was   less   useful   in  

distinguishing  a  fracture  from  a  soft  tissue  injury.  The  next  chapter  will  discuss  

these  findings  in  detail  and  debate  the  use  of  thermal  imaging  as  a  diagnostic  tool  

for   detecting   fractures   in   children,   revisiting   the   pilot   studies’   primary   and  

secondary  objectives.    

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Chapter  5                                        

    89  

 Chapter  5  Discussion    

 5.1  Introduction    

The  aim  of  this  chapter  is  to  discuss  the  findings  of  this  pilot  study  in  the  context  

of  the  current  literature  and  evidence  surrounding  the  use  of  thermal  imaging  in  

the   detection   of   fractures.   The   aim   of   this   pilot   study   was   to   explore   the  

effectiveness  of  thermal   imaging  in  diagnosing  wrist   fractures  in  children  using  

plain  X-­‐rays  as   the  gold  standard  and  determine  whether  a   full  phase   III   study  

was  viable.      Haynes  and  Sackett  (2002)  suggest  that  the  value  of  a  diagnostic  test  

is   to   distinguish   between   the   normal   and   the   abnormal   within   the   clinical  

context.   This   chapter   will   discuss   this   theory,   exploring   the   strengths   and  

weaknesses  of   this  research  study  by  revisiting   the  research  objective  posed  in  

chapter   one   to   determine   whether   a   full   scale   phase   III   study   should   be  

commenced  into  the  use  of  thermal  imaging  for  the  detection  of  distal  ulna  and  

radius  fractures  using  thermal  imaging  as  a  diagnostic  tool  on  children.      

 

5.2  Primary  objectives  for  this  study    

1. To  determine  whether  thermal  imaging  (thermography)  can  be  used  to  detect  

fractures  in  children’s  wrists.    

2. To  examine  whether  patients  with  a  1°C  or  greater  difference  in  temperature  

on  thermal  imaging  results  are  more  likely  to  have  a  fracture  to  their  wrist.    

3. To  determine  in  patients  who  it  is  clinically  sensible  to  suspect  a  fracture,  does  

the  level  of  the  test  result  distinguish  those  with  or  without  a  fracture.    

 

 

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5.2.1  To  determine  whether  thermal  imaging  (thermography)  can  be  used  to  detect  

the  fractures  in  children’s  wrists    

The   main   objective   for   this   pilot   study   was   to   determine   whether   thermal  

imaging  could  be  used  as  a  diagnostic  tool  to  detect  fractures  in  children’s  wrists.  

The  obvious  fundamental  factor  to  this  question  is  whether  the  fracture  site  does  

have  a  different  temperature  to  that  of  a  soft  tissue  injury  or  uninjured  wrist?    

 

The  evidence  presented  in  this  study  suggests  that  fractures  do  show  a  different  

temperature   recording     (>1°C)   in   the   majority   of   cases   (31   out   of   34)   when  

compared   to   that   of   a   child   with   an   injury   to   their   wrist   with   no   fracture  

reported.  When  compared  to  the  control  group,  five  of  the  participants  recorded  

no   difference   in   temperature   between   the   control   group   and   the   injury   group.  

Four  of  these  children  had  sustained  soft  tissue  injuries  of  varying  degrees  and  

one  had  a  fracture  noted  on  X-­‐ray.  This  evidence  suggests  that  thermal  imaging  

does  detect  a  difference  in  pathology  at  differing  levels  and,  as  this  study  results  

suggests,  detected  temperature  differentials  in  33  of  the  34  children  presenting  

with  fractures.  However,  the  results  do  demonstrate  that  the  thermal  imaging  is  

not  100%  accurate  at  determining  significant  temperature  changes  to  determine  

the  difference  between  a  soft  tissue  injury  and  a  fracture  (31  out  of  34  cases).      

 

Marsell  and  Einhorn  (2011)  and  Niehof  et  al.  (2008)  in  their  respective  research  

reported   a   similar   concern   that   thermal   imaging   did   have   limited   scope   in  

determining  the  difference  between  a  severe  inflammatory  response  from  a  soft  

tissue   injury   and   that   caused   by   a   fracture.   On   interrogation   of   the   data   there  

    91  

appears  to  be  an  inconsistency  in  the  level  of  exothermic  reaction  produced  by  a  

fracture  in  a  child.  There  is  good  evidence  to  suggest  that  young  children’s  bones  

heal  much  faster  than  their  older  peers.  This  is  due  to  the  nature  of  the  difference  

in  bone  make  up  and  the  response  activated  following  injury,  which  may  equate  

to   a   greater   degree   of   heat   produced  by   the   inflammatory   response.  However,  

there   has   been  no   study   conducted   to   evaluate   how  quickly   this   inflammatory  

response   reacts   to   a   fracture   or   whether   there   is   a   delay   in   this  

healing/inflammatory  process.  The  children  studied   in   this  paper  all  presented  

to  the  emergency  department  having  sustained  an  injury  to  their  wrist/forearm  

with   varying   degrees   of   severity   and   mechanism,   all   within   6   hours   of   their  

injury.    

 

The   data   suggests   that   there   is   no   correlation   between   the   time   of   injury   and  

time  of  data  capture.  However,  one  can  hypothesise  that  in  some  circumstances  

the   inflammatory   response   is   delayed   and   therefore   the   thermal   imaging   was  

conducted   too   early   to   pick   up   the   exothermic   changes.   There   was   a   clinical  

suspicion   pre-­‐test   that   a   fracture   was   present   in   all   children   enrolled   in   this  

study  as  elicited  by  the  inclusion  criteria  (Webster,  2006).  The  results  from  this  

study   demonstrate   that   thermal   imaging   can   detect   temperature   differences  

between  wrists   that   have   sustained   a   traumatic   injury  when   compared   to   one  

that  had  no  injury.  This  correlates  well  with  the  studies  conducted  by  Merkulov  

et  al.  (2008)  and  Hosie  et  al.  (1989).  Merkulov  et  al.  (2008)  found  that  thermal  

imaging   could   be   used   to   determine   whether   a   fracture   was   present   but  

published   no   sensitivity   or   specificity   value   in   his   study   to   determine   its   true  

value.   The   results   from   the   main   study,   to   determine   whether   the   thermal  

    92  

imaging   camera   could   detect   a   difference   in   temperature   between   the   injured  

wrist  and  the  non-­‐injured  arm,  reported  a  mean  variance  of   .90  ˚C  (P  =  0.0001)  

when  compared  with  the  control.  This  suggests  a  significant  difference  between  

the   injured   limbs  when   compared   to   one  where   no   injury   has   been   sustained.  

However,  this  study  shows  that  even  if  the  temperature  level  in  which  a  fracture  

was  diagnosed  was  reduced  to  >0.9°  C  none  of  the  missed  fractures  would  have  

been  diagnosed.    

 

These  results  correlate  well  with  research  conducted  by  Gradl  et  al.  (2003)  who  

found   that,   although   thermal   imaging   could   be   used   to   detect   the   presence   of  

injury,   they   were   less   useful   in   determining   whether   a   fracture   was   present.  

However,   Gradl   et   al.’s   (2003)   study  was   conducted   16  weeks   post   injury   and  

thus  it  be  could  argued  that  most  of  the  exothermic  reaction  due  to  the  healing  

process  would  have   ceased  by   the   time   the   imaging  was   carried  out.  All  of   the  

studies   examined   within   the   systematic   review   supported   the   above   findings  

that   thermal   imaging  could  be  used  with  varying  degrees  of  accuracy   to  detect  

injury,   though   all   of   the   papers   reviewed   demonstrated   different   degrees   of  

accuracy  in  terms  of  specificity  and  sensitivity.    Thermal  imaging  can  be  used  to  

detect  fractures  in  children,  however  its  accuracy  in  determining  the  difference  

between  a  fracture  and  a  soft  tissue  injury  is  variable  and  it  has  been  proven  not  

to  be  100%  accurate  in  detecting  fractures  in  children’s  wrists.  

 

 

 

 

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5.2.2:  To  examine  whether  patients  with  a  1°C  or  greater  difference  in  temperature  

on  thermal  imaging  results  are  more  likely  to  have  a  fracture  ot  their  wrist.    

 

Another   fundamental  questions  stated   for   this   research  was   to  determine  whether  

children  with  a  higher  temperature  recording  in  their  injured  wrist  were  more  likely  

to  have  a  fracture  when  compared  to  the  control.    A  higher  mean  temperature  was  

recorded   in   children  with   fractures   to   their  wrists  when   compared   to   the   control  

(uninjured  group)  in  31  out  of  34  cases.  The  mean  temperature  difference  reported  

between  the  injured  wrist  and  the  uninjured  wrist  was  0.90°C  which  statically  was  

shown  to  be  significant.  When  the  fracture  group  was  compared  with  the  soft  tissue  

injury   group   a   P   value   of   .00001   was   recorded,   which   suggests   that   there   was   a  

statistically  significant  difference  between  the   two  groups  with  a  mean  variance  of  

1.08   ˚C   recorded  overall.  The   fracture  group  recorded  higher   temperatures  overall  

when  compared  with  the  soft  tissue  group.  

 

When  the  temperature  of   the   fracture  group  (injured  arm)  was  compared  with  

the  control  (uninjured  arm)  group  a  mean  variance  of  1.28°  C  (p  =  0.0001)  was  

recorded.  This  result  is  highly  significant  for  this  study  as  it  suggests  that  when  a  

fracture   is   present   a   temperature   difference   of   greater   than   1˚C   is   recorded.  

However  no  other  study  has  reported  similar  findings.  Hosie  et  al.  (1989)  did  not  

comment  on  the  temperature  gradient  recorded  in  the  affected  limb,  they  simply  

suggested   that   a   fracture   was   hotter   than   a   non-­‐fracture.   No   other   study   has  

commented  on  the  level  of  temperature  rise  required  to  differentiate  between  a  

fracture   and   a   soft   tissue   injury.   Using   a   greater   than   1˚C   target   temperature  

would   have   meant   that   three   fractures   would   have   been   missed.   Two   of   the  

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fractures   as   noted   previously  were   clinically   obvious   and  would   have   been   X-­‐

rayed   on   clinical   grounds,   one   child   (11   year   old,   male)   with   a   clinically  

significant  green  stick  fracture  would  have  been  missed  as  a  temperature  rise  of  

0.01   ˚C   was   recorded,   however   this   rise   in   temperature   would   correlate   with  

Jung   and   Zuber’s   (1998,   p.   15)   findings   that   any   rise   in   temperature   could   be  

considered   pathological   no  matter   how   small.    When   the   non-­‐fractured   injury  

group   was   compared   with   their   control   a   temperature   recording   of   .5°C   was  

recorded   and   when   compared   with   the   fractured   injury   group   a   mean  

temperature   variance   of   1.08°   C   was   recorded.   However   these   differences   in  

temperature   were   not   found   consistently   throughout   the   study.   Neihof   et   al.  

(2008)   found   similar   inconsistencies   reporting   a   sensitivity   (71%)   and  

specificity   (64%)  within   their   study;   they   deduced   that   thermal   imaging   could  

not  be  used  as  a  primary  diagnostic  test  to  determine  the  difference  between  a  

soft  tissue  injury  and  a  fracture.      

 

Four  subjects  from  the  soft  tissue  group  recorded  temperatures  greater  than  1.0  

centigrade   in   the   affected   limb  when   compared  with   their   control;   this  would  

mean  that  four  patients  would  have  received  needless  X-­‐rays  where  no  fracture  

was  noted  either  by   the  examining  clinician  or  consultant  radiologist.  However  

an   argument   could   be   posed   that   these   represent   more   serious   soft   tissue  

damage   and   therefore   the   X-­‐ray   examination   of   these   subjects  may   have   been  

warranted.    

 

A  simple  logistic  regression  analysis  was  performed  examining  the  temperature  

data   recorded   in   this   study,   using   the   correct   diagnosis   of   a   fracture   as   the  

    95  

dependent   variable   and   the   differing   temperature   recordings   as   predictor  

variables.   A   total   of   67   cases   were   analysed   and   the   full   model   significantly  

predicted   fracture   detection   rates   (Chi-­‐square   =   14.77,   df=1p   =0.0001).   The  

values  of  the  coefficient  reveal  that  an  increase  in  temperature  by  3˚C  increases  

the  odds  of  a  fracture  detection  from  a  factor  of  0.67  at  34˚C  to  a  factor  of  8.23  at  

37  ˚C,  suggesting  that  the  warmer  the  limb  the  greater  likelihood  in  detecting  a  

fracture   using   thermography   as   a   diagnostic   tool.   The   results   from   the   study  

would   suggest   that   thermal   imaging   could   detect   temperature   rises   associated  

with   traumatic   injury   to  a  child's  wrist  when  compared   to   the  uninjured  wrist.  

There  also  appears  to  be  a  correlation  between  the  differentiation  of  a   fracture  

and  soft   tissue   injury  when  compared   to   the  uninjured  wrist.  The   results   from  

this   study   do   suggest   that   a   temperature   difference   of   1°C   or   more   is   an  

indication  that  a  fracture  is  present,  however  these  results  are  inconsistent  and,  

as   this   study   has   reported,   the   accuracy   of   the   diagnostic   test   in   determining  

temperature  rise  is  variable.    

 

5.2.3:  To  determine  in  patients  who  it  is  clinically  sensible  to  suspect  a  fracture,  does  

the  level  of  the  test  result  distinguish  those  with  or  without  a  fracture?    

In  this  study  the  sensitivity  was  calculated  at  91.18%  which  suggests  that  out  of  

100  children  91  would  have   their   fracture  detected  using   thermal   imaging,   the  

sensitivity   was   further   increased   to   96.7%   when   combined   with   the   clinical  

examination.  

 

Two  of  the  three  children  where  the  thermal  image  did  not  detect  a  raise  in  heat  

signature,   who   had   fractures   of   their   wrist   detected   by   X-­‐rays,   had   grossly  

    96  

deformed   limbs  which   can   be   seen   directly   on   the   thermal   picture,   thus   these  

subjects  would   have   been   sent   automatically   for   an   X-­‐ray.   One   fracture  would  

have  been  completely  missed  if  thermal  imaging  alone  were  used  to  diagnose  the  

presence   of   a   fracture.   According   to   Pountos   et   al.   (2010)   this   compares   very  

favourably  when   compared   to   the   considered   “gold   standard”   of   X-­‐rays.   Their  

study  compared  the  effectiveness  of  ultra  sound  versus  X-­‐rays  in  detecting  green  

stick/torus   fractures   in   children's   wrists.   Their   results   found   that,   out   of   79  

fractures  detected,  only  75  were  seen  on  X-­‐ray  giving  a  sensitivity  of  95.1%.  The  

use  of   thermal   imaging   to  rule  out   fractures   in  children  showed  a  specificity  of  

88%   which   suggests   that   12   out   of   100   children   would   have   a   needless  

investigation.  Given   that   the  reported  sensitivity  of  X-­‐ray   interpretation  ranges  

between   93%   to   98%     (Mayhue   et   al.,   1989;   Freij   et   al.,   1996;   Benger,   2002;  

Tackara   et   al.,   2002)   there   is   a   theoretical   chance   that   the   soft   tissue   injuries  

recording  temperature  rises  greater  than  1°C    (4)  could  have  been  fractures  that  

were  missed   on   X-­‐ray   interpretation.   However,   this   is   unlikely   as   none   of   the  

patients   re-­‐attended   the   department   following   their   injury   and   consultant  

radiologists  reported  all  of  the  X-­‐rays,  which  heightens  the  sensitivity  to  98.8%  

(Tackara  et  al.,  2002).  

   

As   discussed   previously   in   the   results   chapter,   Akobeng   (2007,   p.   490)   argues  

that   likelihood  in  association  with  pre-­‐test  and  post-­‐test  probabilities  are  more  

clinically  useful  than  sensitivity  and  specificity,  especially  when  determining  the  

value  of  a  specific  diagnostic  test  (Atta,  2003,  p.  111).  The  likelihood  ratio  for  a  

positive   test   was   calculated   at   7.52,   which   suggests   that   a   child   with   a  

temperature  recording  greater  than  1°C  in  their  injured  wrist  is  7.5  times  more  

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likely   to  have  a   fracture   than  not  have  a   fracture.  This   result  predicts   that   it   is  

highly   probable   that   thermal   imaging   is   able   to   detect   a   fracture   in   children  

rather  than  it  just  being  by  chance.    The  negative  likelihood  ratio  was  calculated  

to  be  0.1;  this  means  that  the  probability  of  having  a  negative  test  for  individuals  

with  a  fracture  is  0.10  times  of  that  of  those  without  a  fracture  (Jaescheke,  Guyatt  

&  Limer,  2002,  p.  123).    

 

To  answer  this  question  fully  Mant  (2005)  and  Akobeng  (2007,  p.  489)  suggest  

the  pre-­‐test  and  the  post-­‐test  probability  must  be  examined.  Heston  and  Thomas  

(2011)   would   argue   that   although   sensitivity   and   specificity   can   be   useful   in  

interpretation   of   results   they   do   not   demonstrate   the   whole   picture.   They  

suggest   that   predictive   values   are   much   more   relevant   in   demonstrating   the  

accuracy   of   a   diagnostic   test.   Fagan’s   Nomagram   (Sackett   et   al.,   1991)   for  

predicting   post-­‐test   probability   calculated   that   the   positive   predictive   value  

(PPV)  for  thermal  imaging  to  detect  a  fracture  as  89%  (95%CI  75%  to  95%)  with  

0.11%   false   positives   and   the   negative   predictive   value   (NPV)   for   thermal  

imaging  to  rule  out  a  fracture  was  calculated  to  be  9%  (95%CI:  3%  to  24%).      

 

The  fact  that  the  number  of  patients  in  the  non-­‐fractured  group  is  very  similar  in  

number  to  the  fractured  group  is  very  significant  in  regard  to  the  accuracy  of  the  

NPV   and  PPV   (Altman  &  Bland,   1994).   The   prevalence   of   fractures  within   this  

study   correlates   well   with   the   pre-­‐study   audit   into   the   number   of   children  

presenting   to   the   emergency   department   with   painful   wrists   conducted   in  

August  2007,  which  recorded  76  patients  presenting  to  ED  with  painful  wrists  of  

which  39  had  fractures  detected  on  X-­‐ray.      

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Deeks   (2004,  p.  169)  suggests   that  another  useful  way  of  determining   the   true  

value  of  a  diagnostic  test  is  to  calculate  the  odds  ratio  of  a  specific  test.  Although  

the  odds  ratio   is  not  a  useful  statistic   for  determining   the  overall  accuracy  of  a  

test   for   an   individual   patient,   it   does   have   a   value   as   a   single   measure   that  

determines  the  overall  accuracy  of  a  test  (Mant,  2005,  p.  165).  

 

Figure  10:  A  Nomogram  for  applying  likelihood  ratios    (Fagan  1975)    

 (Reproduced  from  Sackett,  Haynes,  Guyatt  &  Tugwell,  p  90)    The  odds  ratio  for  this  study  has  been  calculated  at  75%,  which  suggest  that  the  

predictive  value  for  the  accuracy  of  thermal  imaging  as  a  whole,  in  this  study  was  

poor.   The   discussion   above   suggests   that   although   thermal   imaging   can  

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distinguish   between   those   children   presenting   with   or   without   a   fracture,   its  

accuracy   in  diagnosing  a   fracture  cannot  be  guaranteed  and  does  not  reach  the  

accuracy   of   X-­‐rays,   which   are   considered   to   be   the   current   diagnostic   gold  

standard.    

5.3  Secondary  objective  for  this  study    

   

• To   test   the   feasibility   of   a   full-­‐scale   study,   including   the   process  

surrounding   data   collection,   methodology,   protocol   adherence,   and  

research  question  design.  

 

5.3.1:   To   test   the   feasibility   of   a   full-­‐scale   study,   including   the   process  surrounding   data   collection,   methodology,   protocol   adherence,   and   research  question  design.  

Thabane  (2010)  states  the  rationale  for  conducting  a  pilot  study  is  to  assess  the  

process,   resource   management   and   specific   scientific   methodology   of   a   study  

before   conducting   a   full   phase   III   trial.     In   effect   testing   the   feasibility   of  

conducting  a  larger  scale  study  (Arnold  et  al.,  2009).  This  study  was  conducted  in  

busy   children’s   emergency   departments   and   thus   the   process   of   obtaining   the  

recruitment   rates   required   for   a   fully   powered   study   could   be   adequately  

achieved   over   a   six-­‐month   period.   Even   allowing   for   refusal   rates   and   data  

capture   complications   this   should   produce   over   400   hundred   children  

presenting   to   the   department  with   injuries   to   their  wrists.     The   inclusion   and  

exclusion  process  observed  by   the   study  meant   that  no   child  with  an   injury   to  

their   forearm   was   missed   and   that   all   the   children   attending   the   emergency  

department  with  an  injury  to  their  wrist  were  given  analgesia  in  a  timely  fashion  

and  correctly  triaged  (Webster  et  al.  2006).  Two  children  meeting  the  inclusion  

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criteria  for  the  study  withdrew  from  the  study  due  to  pain  and  distress  caused  by  

their  injuries.  Both  of  these  children  had  grossly  deformed  limbs  and  thus  were  

too   distressed   to   be   involved   despite   analgesia   and   distraction   methods.  

Although   the  numbers  of  patients  opting  out  were   low,   there   is   a   concern   that  

this  could  skew  the  overall  results  and  thus  not  fully  test  the  hypothesis.  The  fact  

that   the   two  patients  who  withdrew   from   the   trial   had  very  obvious   fractures,  

and  two  of  the  three  fractures  which  were  not  picked  up  by  the  thermal  imaging  

camera   also   had   very   obvious   fractures   is   extremely   important   to   the   studies  

overall  results.  Thus  the  principle  that  thermal  imaging  could  detect  all  types  of  

fractures  was  not   tested  or  proven.  A  principle  objective  of   the   larger  phase  III  

study   would   be   to   ensure   that   this   area   would   be   investigated   in   depth,   to  

investigate  whether  grossly  deformed  fractures  could  be  detected  and  if  not  why  

not?  However   all   of   the  parents  of   the  patients   enrolled  onto   this   study   stated  

that  they  thought  the  study  was  worthwhile  and  regarded  the  trial  as  a  positive  

experience,  this  data  was  only  collected  anecdotally  and  thus  could  not  form  part  

of   the   results   or   data   analysis.     Should   a   phase   III   study   be   commenced   the  

researcher   should   expand   the   methodology   to   include   combined   research  

methodological  approach  (Carter  and  Henderson,  2009,  p  380).    Qualitative  data  

should   be   investigated   in   terms  of   patient   and  parent   satisfaction,   information  

regarding  concept  and  process  testing  should  be  further  investigated  and  a  more  

naturalistic  approach  used  for  data  collection  (Bickman,  L.,  &  Rog,  D.,  2009,  p  4).    

 The  resources  available  to  this  study  were  heavily  limited  by  the  loan  period  of  

the  camera  and  the  lack  of  funding  associated  within  this  research  project.  For  a  

full  phase  III  trial  to  take  place,  several  camera  systems  would  be  needed  and  full  

funding   achieved   in   order   to   fully   train   staff   in   the   use   of   the   camera   and   the  

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diagnostic   package   associated   with   the   data   capture.   The   need   for   more  

operators   to   be   trained   in   the   use   of   thermal   imaging  would   be   crucial   to   the  

success  of  any  further  larger  study.  As  demonstrated  in  previous  studies  the  use  

of   thermal   imaging   can   be   inconsistent   and   very   user   dependent   and   thus  

consistent   accurate   training   must   be   provided   to   the   user   group   (Ring   and  

Ammer,  2000,  pp.  7  -­‐14)  This  could  be  easily  achieved  by  sending  personnel  to  

the   University   of   Glamorgan   to   complete   the  medical   thermal   imaging   course,  

which  is  conducted  over  one  week.  

 

The   ethics   committee   expressed   a   concern   that   children   would   have   to   wait  

longer   for   their   subsequent   diagnosis   and   treatment.   This   concern   was  

unfounded,  due  to  the  thermal  imaging  taking  place  alongside  the  x-­‐ray  capture,  

this   had   three   major   advantages:   firstly   that   the   child’s   care   and   subsequent  

treatment   were   not   delayed   in   any   way,   secondly   that   the   positioning   of   the  

child’s  wrist  was   conducted   by   the   same   person,   thus   ensuring   consistency   in  

image   capture   and   thirdly   that   the   imaging  was   taking   place   in   a   temperature  

controlled  room  with  restricted  air  flow.  This  approach  complies  to  the  guidance  

stipulated  by  the  European  Thermography  Association  standard  for  carrying  out  

diagnostic   studies   using   infra   imaging   (Clark   &   DeCalcina-­‐Goff,   1997)   as  

discussed   in   chapter   three.   If   a   larger   study   was   to   be   conducted   the   camera  

would  need  to  be  perminatley  fixed  in  one  room,  this  would  reduce  the  chances  

of   the  camera  being  damaged   in   the  process  of  moving   it   from     room  to   room,  

and    would  ensure  that  the  camera  is  always  ready  to  use  at  any  time.  This  was  

an  exstremely     important   learing  point   for  the  reseracher  as  the  damage  to  the  

camera  caused  huge  delays  to  the  research  process  and  resulted  in  the  reduced  

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sample  size.    

 

However  the  pilot  study  did  meet  its  secondary  objective  to  test  the  feasibilty  of  

the   research     design   in   the   clinical   area   (Van   Teijlingen,   Rennine,   Hundley,  

Graham,   2001,p   289)   Overall   the   methodology   appeared   to   be   acheivable,  

requiring  minimal  change  for  a  mulit  centered    phase  III  study.  This  pilot  study  

has  provided  the  researcher  with  an  excellent    grounding  of  how  best  to  procede  

and     conduct  a   larger  study   .  This   study  answers   the  research  questions  posed  

within   the   limitations   of   the   pilot   study   design.   The   study   provides   the  

researcher  with  a  template  to  follow  in  order  to  produce  a  study  design  which  is  

both  valuable  in  terms  of  answering  the  research  question  and  reliable  in  terms  

of   acurately   informing   the   hypotheis   posed.   The   limitations   of   this   study   are  

discussed     fully   in   the   limitations     section  below  and  although   the  results   from  

this   study   should   be   treated   cautiously   there   is   no   doubt   that   they   inform   the  

overall  sceintific  question  of  whether  thermal   imaging  is  a  usful  diagnostic  tool  

in  detecting  fracture  of  the  ulna  and  raduis    in  children.    

 

5.4Limitations    

 A   great   deal   of   the   limitations   surrounding   the   use   of   thermal   imaging   in  

research   studies  described  by  Ring   and  Ammer   (2000)  were   addressed  within  

this  studies  design,  however  there  have  been  some  unavoidable  limitations.    One  

of  the  major  concerns  for  the  chief  investigator  of  this  study  has  been  the  limited  

sample   size   used.   Despite   this,   through   evidence   gained   within   the   literature  

review  and   from  other  similar  papers,   this  study  has  one  of   the   largest  sample  

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sizes   documented   for   thermal   imaging   research   in   this   field   (Ammer,   2006,   p.  

16).  The  limited  sample  size  was  due  to  the  short  loan  time  the  researcher  was  

allocated  the  camera  and  breakage  of  the  camera  equipment.  A  solution  for  this  

would  have  been  to  initially  run  this  study  on  all  patients  presenting  with  known  

fractures   in   a   fracture   clinic,   this  would   have   greatly   enhanced   the   population  

size  and,  as  an  initial  phase  II  study,  supported  either  the  hypothesis  or  the  null  

hypothesis  (Ippokratis,  2010).  

 

 The  initial  study  was  scheduled  to  be  four  months  in  duration.  This  would  have  

provided  the  study  with  over  three  hundred  subjects,  which  would  have  doubled  

the  sample  size  required  to  fulfill  the  power  calculated  for  this  study.  However,  

due  to  the  need  to  repair  the  camera  mid  study  the  sample  size  was  only  taken  

over   a   month.   Polit,   Beck   and   Hungler   (2001)   suggest   that   one   of   the   largest  

threats  to  the  validity  of  a  study  is  the  lack  of  an  adequate  sample  size.  Brink  and  

Wood  (1998)  suggest  that  this   is  often  the  case  with  clinical  studies  or  real   life  

world  research  where  the  population  size  is  limited  is  due  to  location  and  clinical  

situation.  Dawes  (2005)  suggests  that  the  sampling  size  can  be  a  major  concern  

but  if  properly  managed  its  effects  can  be  limited.    

 

Having  too  few  patients  in  the  study  can  lead  to  two  sorts  of  concerns.  The  first  

of  these  are  type  1  errors  where  the  intervention  is  shown  to  be  effective  when  

in   reality   it   is   not.   To   protect   the   study   from   making   this   type   of   error   a   P  

calculation   was   performed,   this   consistently   showed   a   P   value   of   less   than  

0.0001,   which   means   that   there   is   a   less   than   1%   chance   that   an   error   has  

occurred  within   this   sample.  This   suggests   that   there   is   a   less   than  1%  chance  

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that  these  results  occurred  by  chance.  Gardner  and  Altman  (1986)  suggest  that  

confidence   intervals   are   more   reliable   in   assessing   the   validity   of   a   studies  

results   and   its   effect   on   the   population   sample.   This   study   showed   a   P   value  

between   the   control   and   the   test   group   is   =   0.0001,  which   suggests   there   is   a  

statistically   significant   difference   between   the   injury   group   and   their   control  

with   a   mean   variance   of   0.90°C,   showing   95%   CI:   0.72   to   1.079.   This   would  

suggest   that   thermal   imaging  could  be  used  to  detect  changes  due  to  traumatic  

injury   in   children’s   wrists;   however,   it   does   not   demonstrate   the   ability   of  

thermal  imaging  to  differentiate  between  a  fracture  and  a  soft  tissue  injury.  

The   second   concern   for   this   study   is   that   a   type   II   error   may   have   occurred.  

Although   the   results   of   this   study   have   been  promising   a   larger,  multi-­‐centred  

study  must  be  conducted  before  any  true  results  can  be  extrapolated   from  this  

study.  

 

Another   limitation   to   this   study   is   the   clinical   arena   in   which   the   study   was  

carried   out,   as   previously   alluded   to   in   chapter   4.   Sackett   and   Haynes   (2002)  

argue  that  one  should  be  cautious  in  assuming  that  the  sensitivity  and  specificity  

remains   constant   across   all   settings.   Although   the   sample   was   taken   from   a  

group   of   children   attending   an   emergency   department  with   an   injury   to   their  

wrist,   this   sample   could   be   different   to   a   group   attending   a  walk-­‐in   centre   or  

general  practitioners  surgery  with  a  similar  complaint.  Wagner  (2000)  suggests  

that   patients   may   be   self-­‐selecting,   with   children   more   likely   to   attend   the  

emergency  department  with  a  broken  limb  while  those  who  believed  their  injury  

was  less  severe  would  visit  their  general  practitioner  or  walk-­‐in  center.  Although  

this  does  not  affect   this  studies  result  per  se   it  may  alter   the  results   found   in  a  

    105  

similar  Phase   III  study   involving  a  remote  primary  care  setting,  as   indicated  as  

the  eventual  outcomes  for  this  thermal  imaging  research.  There  is  no  doubt  that  

if   thermal   imaging   is   to   be   used,   as   a   diagnostic   test   to   detect   fractures   in  

children,   then   its   greatest   use  would   be   in   a   primary   care   setting  with   limited  

resources   and   budget.   Therefore   a   phase   III   study   would   need   to   take   place  

within  the  primary  care  setting  and  conducted  using  the  eventual  target  group.    

 

One  of  the  problems  when  designing  this  study  was  the  lack  of  previous  research  

into   this   specific   subject.   This   led   to   difficulties   in   getting   the   design   concept  

right.  The  limited  research  surrounding  this  area  of  study  has  made  it  difficult  to  

calculate   a   true   power,   hence   the   requirement   for   a   pilot   study.  However,   this  

exploration  into  uncharted  territory  has  added  to  the  excitement  of  the  study  in  

the   fact   that   the   study   results   were   unique   and   gained   without   any   pre  

conception  or   bias.   Field   and  Morse   (1985)   suggest   that   because   there   is   little  

known   about   this   domain   and   that   the   present   knowledge   and   theories  

surrounding   the   use   of   thermal   imaging   could   be   biased,   that   a   mixed  

methodological  approach  should  have  been  used.  They  suggest  that  a  qualitative  

approach   may   lead   to   an   increased   understanding   of   the   subject   matter.   The  

need   to   assess   the   “real   Life”   behind   this   subject   is   paramount   (Hutchinson,  

1985,   Bickman   &   Rog,   2009,   p   11)   for   the   researcher   to   fully   understand   the  

concept   studied.   This   study   should   have   included   qualitative   data   from   the  

patient  and   their  parent  regarding   their  understanding  and  expectations  of   the  

thermal   imaging   process.   The   study   should   have   used   a   phenomenological  

approach  to  gain  a  better  understanding  of  the  “lived  experience  “of  the  patient  

and  their  families  undergoing  the  diagnostic  test  in  order  to  investigate  the  true  

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clinical  value  of  this  diagnostic  approach  (Guenther,  Stiles  &  Champion,  2012,  p  

602).   Guenther   et   al   (2012)  used   a   phenomenological   approach   to   analyse   the  

lived  experience  of  the  diagnostic  process  for  women  with  ovarian  cancer,  they  

concluded   that   this   approach   gave   then   a   much   greater   understanding   of   the  

diagnostic   approach   used   and   how   the   diagnostic   process   can   be   adapted   to  

meet  the  need  of  the  patients  and  their  families.  

Another   limitation   to   this   study   was   the   lack   of   research   funding,   due   to   the  

controls   imposed  at   the   time  of   the  writing  of   the  study  proposal.  The  national  

research-­‐funding  organisation  would  not  fund  PHD  or  Doctorate  studies,  which  

severely  impeded  the  resources  available  for  this  study.  The  camera  was  loaned  

to   the   study   by   the   national   research   equipment   laboratory,   which   imposed   a  

time  frame  on  the  loan  period  due  to  a  long  waiting  list  for  the  camera  for  other  

research   studies.   The   chief   investigator   applied   to   loan   the   camera   again   the  

following  year  but   funding  was  removed  from  the  national   laboratory  and  they  

were  no  longer  able  to  provide  loan  equipment.    The  study  would  have  achieved  

its  sample  size  and  run  for  a  greater  period  of  time  if  funding  were  provided  for  

the  provision  of  a  camera  and  equipment.  A  major  recommendation  for  a  further,  

larger  study  of  this  type  would  be  to  gain  funding  in  order  to  purchase  its  own  

research  equipment  for  the  study.    

 

Cooke  et  al.’s  (2005)  concept  paper  suggests  that  thermal  imaging  may  be  more  

accurate   twenty-­‐four   hours   post   injury   due   to   the   inflammatory   response.   A  

thermal   image   taken   at   the   time   of   the   fracture   clinic   review  may   answer   this  

question   and   prove   more   clinically   accurate.   Further   studies   should   include  

taking  thermal  images  at  the  time  of  the  fracture  clinic  follow  up,  this  would  be  

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useful  in  answering  the  question  regarding  the  optimal  time  of  thermal  imaging.  

It   could   also   act   as   a   further   validation   of   the   hypothesis   given   that   all   of   the  

patients   returning   to   fracture   clinic   do   have   fractures   (Silva,   2012;   Lindaman,  

2001).    

Another   limitation   to   this   study   was   that   no   formal   follow   up   was   arranged   for  

patients   to   ascertain   whether   patients   who   undergo   thermal   imaging   would   fare  

better  than  similar  patients  who  do  not.  Sackett  and  Haynes  (2002)  suggest  that  to  

fully  investigate  whether  a  diagnostic  test  has  true  advantages  over  an  alternative  is  

to  determine  whether  patients  who  undergo  that  test  fare  better  than  similar  patient  

who   do   not.   The   evidence   produced   within   this   study   demonstrates   no   clinical  

advantage  for  the  patients  presenting  to  an  emergency  department  to  have  thermal  

imaging   for   their   diagnosis   of   their   fracture   when   compared   with   an   X-­‐ray.   The  

evidence  produced  by  this  paper  would  suggest  that  due  to  the  inconsistencies  in  its  

accuracy  and  its  inability  to  produce  images  that  assist  with  the  exact  location  of  the  

fracture   and/or   the   severity   of   the   fracture   diagnosed,   that   the   use   of   thermal  

imaging   when   compared   with   X-­‐rays   could   be   detrimental   to   the   child’s   care.  

Previous   studies   (Silvia   et   al.,   2012,   pp.   1007-­‐1015)   have   suggested   that   by   using  

thermal   imaging   to   detect   fractures   the   amount   of   needless   exposure   to   ionizing  

radiation  produced  by  X-­‐rays  could  be  reduced.    

 

To   counter   this   argument   there   is   evidence   to   suggest   that   the   levels   of   radiation  

used  in  X-­‐raying  a  child’s  wrist   is  minimal  and  equate  to  3  days  worth  of  naturally  

occurring  radiation  (Belson,  2007,  p.  138;  Wakeford,  2008,  p.  66;  Hart,  Hillier  &  Wall,  

2003,  p.  3).  However,  a  recent  study  conducted  by  Bartley,  Metayer,  Selvin,  Ducore  

and  Buffler  (2010,  pp.  1-­‐10)  has  called  this  previous  theory  into  question.  Bartley  et  

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al.   (2010,  p.  1)   suggest   that   exposure   to  post  natal  diagnostic  X-­‐ray’s   is   associated  

with  an  increased  risk  of  childhood  acute  lymphoid  leukemia  (ALL).  Their  research  

has  found  that  in  children  below  the  age  of  15  who  have  had  three  or  more  X-­‐ray’s  in  

their  lifetime,  show  a  greater  risk  of  contracting  acute  lymphoid  leukaemia.  However  

they   do   state   that   these   results  must   be   used   cautiously   and   further   investigation  

into   this   subject   carried   out.     This   does   suggest   that   reducing   the   risk   (however  

small)   to   children   from   the   exposure   of   ionizing   radiation   may   warrant   further  

investigation.   Nevertheless   it   does   not   negate   the   evidence   published   within   this  

paper  regarding  the  accuracy  of   the  thermal   imaging  for  the  detection  of   fractures.  

The   evidence   produced   in   this   paper   suggests   that   87%   of   patients   who   had   no  

fracture   reported   following   their   X-­‐ray   could   have   avoided   X-­‐rays   if   the   thermal  

imaging   results   were   used   instead.   This   poses   the   question   of   whether   thermal  

imaging   has   a   role   in   ruling   out   a   fracture,   rather   than   ruling   them   in,   the   results  

from   this   study   suggests   that   30   patients  would   not   have   received   an  X-­‐ray  when  

clinical  examination  and  thermal  imaging  alone  was  used.  This  would  have  resulted  

in   one   clinically   significant   fracture   being   missed   and   four   needless   X-­‐rays   being  

conducted.  With   this  evidence,  one  could  deduce   that  29  patients  could  have   fared  

better  from  not  having  an  X-­‐ray  in  the  first  place.    

 

One  of  the  major  draw  backs  to  using  thermal  imaging  when  compared  to  x-­‐rays  is  

that   the   clinician   is   unable   to   identify   which   bone   has   been   fractured   and   the  

severity   of   that   fracture.   However   Noonan   &   Price   (1998.p   149)   ague   that   the  

majority  of  children’s  fractures  requires  no  specific  clinical  intervention  other  than  a  

splint  or  plaster,  unless  clinically  deformed,  so  it  could  be  argued  that  not  knowing  

the  exact  location  /  severity  of  fracture  in  a  non  clinically  deformed  wrist  is  clinically  

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irrelevant   unless   there   is   evidence   of   clinical   deformity   or   the   wrist   is   grossly  

swollen.  Even  in  Salter  Harris  type  fractures  the  level  of  deformity  has  to  be  greater  

than  15°  of  angulation  to  warrant  any  clinical   intervention  other  than  conservative  

plaster  of  Paris  management.  (Armstrong,  Joughlin,  Clarke,  1994  p  176)      

 

The  limitations  posed  in  the  above  section  are  significant,  however  they  should  

not   detract   from   the   important   results   gained   by   this   pilot   study.   All   of   the  

results  gained   from  this   limited  study  support   the   theory   that   thermal   imaging  

can  be  used   to  detect  heat  changes   in  children's  wrists   following   injury,   this   in  

itself   is   a   major   breakthrough   and   should   pave   the   way   for   larger,   more   well  

resourced  studies.    

 

5.5  Could  thermal  imaging  be  used  as  a  screening  tool  for  children’s  fractures  :    

An   area   that   has   not   been   investigated   within   this   research   study   is   whether  

thermal  imaging  could  be  better  utilized  as  a  screening  tool  for  fractures  rather  

than  as  a  purely  diagnostic  tool.  The  definition  of  screening  is:    

“Screening  is  a  process  of  identifying  apparently  healthy  people  who  may  be  at  

increased  risk  of  a  disease  or  condition.  They  can  then  be  offered  information,  

further  tests  and  appropriate  treatment  to  reduce  their  risk  and/or  any  

complications  arising  from  the  disease  or  condition”    

UK  National  screening  committee  (2011p  8)    

The  European  World  Health  Organisation    (Holland,  Stewart,  Masseria,  2006.p5)  

state   that   in   order   for   a   screening   tool   to   be   acceptable   they   must   adhere   to  

Cochrane   &   Holland   (1971p3)   seven   criteria   for   the   evaluation   of   a   screening  

tool:  The  screening  tool  must  be  simple  to  use,  acceptable  to  its  client  and  user  

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group,  the  screening  test  should  be  accurate  in  order  to  give  a  true  measurement  

of   the   condition   or   symptoms   under   investigation,   the   test   results   have   to   be  

repeatable,  capable  of  giving  a  positive  test  when  the  individual  is  being  screen  

(sensitivity)   and   the   test   should   be   able   capable   of   giving   a   negative   finding  

when  the  individual  being  screened  does  not  have  the  condition.  The  expense  of  

the   test  must  be  considered   in  relation   to   the  benefits  of  early  detection   to   the  

disease   or   condition.   Silva   et   al   (2012)   in   their   paper   examined   this   aspect   of  

thermal   imaging   in   greater   depth   (refer   to   chapter   2,   p26),   they   used   thermal  

imaging   to   detect   hot   spots   on   pre   verbal   children’s   limbs   post   injury   to  

determine  where  to  focus  their  X-­‐rays.  They  found  that  the  thermal  imaging  only  

detected  7  –  11  fractures  present  returning  a  sensitivity  of  63%  and  a  specificity  

of   57%.   Hosie,   Wardrope,   Crosby   &   Ferguson   (1987)   concluded   that   thermal  

imaging   may   be   an   acceptable,   reliable   and   cheap   method   of   screening   for  

scaphiod   injuries   in   adults,   however,   they   returned   a   sensitivity   of   77%   and   a  

specificity   of   82%.   The   results   from   this   study   would   suggest   that   if   thermal  

imaging  was  used   in  conjunction  with   the  criteria  established  by  Cochrane  and  

Holland  (1971)  as  a  screening  tool  then  31  out  of  the  34  children  presenting  with  

fractures   to   the  emergency  department  would  have  received   further  diagnostic  

testing   (X-­‐rays),   29   (87%)   children   would   have   been   sent   home   correctly  

without   receiving   further   diagnostics.   If   clinical   examination   had   not   been  

carried  out  on  these  children  prior  to  the  screening  3  fractures  would  have  been  

missed  (sensitivity    =  91%),   five  children  would  have  received  needless  X-­‐rays,  

however,  it  could  be  argued  that  theses  children  would  have  received  the  X-­‐rays  

any  way   as   they  met   the   clinical   criteria   for   receiving   an  X-­‐ray   (Webster   et   al.  

2006).   One   area   that   thermal   imaging   may   be   useful   is   to   screen   pre   verbal  

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children   prior   to   x-­‐rays.   This   could   prevent   “whole   limb”   x-­‐rays   or  

“excludegrams”  by  using  thermal  images  to  detect  injury  sites  and  thus  focus  the  

x-­‐ray  on  specific  sites  rather  than  the  whole  limb.  This  could  be  the  true  role  of  

thermal   imaging   in   the   future   and   should   be   pursued   in   future   studies.     The  

question   of   whether   thermal   imaging   would   be   useful   as   a   clinical   screening  

tools   remains  unanswered,   however   this   study  has  highlighted   that  maybe   the  

clinical   importance   of   thermal   imaging   lies   within   screening   rather   than   in  

diagnostic  testing.  

5.6  Could  Thermal  imaging  be  used  as  a  diagnostic  tool  in  a  remote  setting?    

Another  area  that  remains  unanswered  and  not  included  within  the  

methodology  of  this  study,  is  whether  thermal  imaging  could  be  usual  as  a  

diagnostic  tool  within  the  remote  setting?      

Mant  (2005,  p.  159)  suggests  that  to  extrapolate  these  results  and  use  them  to  

prove  whether  thermal  imaging  may  have  a  use  outside  the  emergency  

department  should  be  treated  cautiously  as  the  population  group  could  be  

altered  toward  the  setting  of  the  test.  Mant  (2005)  suggests  that  the  population  

presenting  to  a  walk-­‐in  center  or  general  practitioner  may  be  different  to  those  

presenting  to  an  Emergency  Department,  therefore  altering  the  prevalence  of  the  

disease.  The  theories  regarding  prevalence  of  disease  would  suggest  that  

patients  may  be  self  selecting,  suggesting  that  children  with  a  fracture  would  be  

more  likely  to  preset  to  an  Emergency  Department  when  compared  to  those  with  

a  soft  tissue  injury,  who  would  either  go  to  a  primary  care  setting  or  not  attend  

at  all.  The  question  of  whether  a  thermal  imaging  could  be  useful  in  the  remote  

setting  has  not  been  answered,  as  the  test  results  are  not  generalisable  to  a  

remote  target  population.  However  the  controlled  environment  in  which  thermal  

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imaging  must  be  taken  would  prove  challenging  within  a  setting  of  limited  

resources  and  could  effect  the  results  further  (Ring,  2000;  Plassman,  2005)  An  

example  of  how  results  could  be  affected  if  the  strict  guidance  for  the  use  of  

thermal  imaging  were  not  adhered  to  was  demonstrated  in  Silvia  et  al.  (2012,  p.  

1014).  This  study  made  no  attempt  to  follow  standard  DITI  preparation  protocol  

and  as  a  result  only  detected  seven  out  of  the  eleven  fractures  reported  in  this  

study.  However  this  study  has  produced  some  promising  results  and  a  feasibility  

study  could  be  developed  using  these  results  as  a  baseline.  The  study  could  

examine  whether  thermal  imaging  does  have  a  use  within  the  pre  hospital  

setting  where  no  X-­‐ray  facility  exists  and  the  need  for  a  reliable,  inexpensive  and  

transportable  diagnostic  test  is  required.    

 

 Further  research  into  the  use  of  thermal  imaging  must  be  conducted  to  examine  

this   theory   in   more   depth.   The   use   of   thermal   imaging   in   the   detection   of  

fractures   per   se   requires   a   large-­‐scale   multi   centred   research   project   with  

adequate   funding   and   resources   made   available   to   the   research   team.   This  

limited   pilot   study   has   highlighted   the   potential   of   using   thermal   imaging   for  

detecting   fractures   in   a   group   of   patients   presenting   to   an   emergency  

department,  supporting  Hosie  et  al.’s  (1987)  original  research  in  this  area.    

 

Thermal   imaging   may   represent   the   future   of   inexpensive,   non-­‐invasive   and  

prove  an  effective  diagnostic  tool,  however  more  research  into  this  area  need  to  

be  conducted  before  it  could  become  part  of  a  solution  to  the  ever  changing  and  

beleaguered  health  care  economy.    

 

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Chapter  6    

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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Chapter  6:  Conclusion  

 This   chapter   will   discuss   the   conclusions   demonstrated   within   this   study,  

summarising  the  key  objectives  for  this  study  and  whether  they  have  been  fully  

achieved.   It  will  document  the  key   findings  and  suggest  ways   in  which  thermal  

imaging   could   become   part   of   a   mainstream   diagnostic   imaging   pathway   for  

children  attending  either  primary  or  secondary  care  services.    This  represents  an  

exciting   avenue   for   future   research   and   could   mark   the   way   for   a   diagnostic  

approach,  which  is  accurate,  reliable  and  fit  for  a  future  health  care  programmes.  

 

The  examination  of  human  physiology  and   its  relationship   to   the   inflammatory  

process  of  healing  has  been  studied  since  the  Roman  age  (Ring  &  Ammer,  2000).  

However,   only   in   the   last   decade   has   thermal   imaging   technology   advanced  

enough   to   be   accurate   and   produce   consistent   results   that   can   be   used   with  

diagnostic   certainty   (Plassmann  et  al.,  2006).  There   is  evidence   to   suggest   that  

infrared   thermography   is   an   excellent   non-­‐invasive   tool   in   the   follow-­‐up   of  

hemangiomas,   vascular   malformations   and   digit   amputations   related   to   re-­‐

implantation,   burns   as   well   as   skin   and   vascular   growth   after   biomaterial  

implants   in   newborns   with   gastroschisis   and   giant   omphaloceles.   In   the  

emergency   department,   it   has   been   shown   to   be   a   valuable   tool   for   rapid  

diagnosis   of   extremity   thrombosis,   varicoceles,   inflammation,   abscesses,  

gangrene  and  wound   infections   (Jung  &  Zuber,   1998;   Saxena  &  Willital,   2007).  

However,  research  into  the  use  of  digital  infrared  thermal  imaging  over  the  last  

thirty  years  to  detect  bony  injury  has  been  limited  to  only  14  other  studies,  with  

only  one  examining  its  use  for  children  (Silva,  2012).  

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This   pilot   study   has   achieved   it   objectives   by   presenting   data   to   demonstrate  

both  clinical  and  statistical  significance  for  the  use  of  thermal  imaging  to  detect  

the  presence  of  a  fracture  in  a  child’s  wrist  post  injury  when  compared  to  a  non-­‐

injured  wrist.  The  main  finding  of  this  research  found  that  there  was  a  statistical  

difference  between   a  non-­‐injured   limb   and   a   fracture   (mean  difference  =  1.28,  

95%CI   .889   to   1.689).   The   result’s   from   this   study   demonstrate   that   children  

presenting   with   fractures   to   there   ulna   and   radius   are   more   likely   to   have   a  

temperature  recording  greater   than  1˚C   than   that  of  a   child  without  a   fracture.  

The   results   found   a   difference   of   1˚C   or   more   in   the   fractured   limb   when  

compared  to  the  non-­‐injured  limb  in  31  out  of  34  cases,  showing  a  sensitivity  of  

91.18   %   and   a   specificity   of   87.85%   when   compared   to   the   gold   standard.  

However,   the   sensitivity   increased  significantly  when  associated  with  a   clinical  

examination   to  96.7%  which  compares  very   favourably  with   the  gold  standard  

(radiographs),   which   in   a   recent   study   produces   a   sensitivity   of   95.1%   when  

applied   to   the   interpretation   of   children’s   X-­‐rays   by   the   average   clinician  

(Pountos   et   al.,   2010).     Although   this   study   has   demonstrated   that   thermal  

imaging  can  be  used  to  detect  fractures  in  children’s  wrists  when  compared  to  a  

non-­‐injured  wrist,  its  reliability  and  accuracy  in  detecting  100%  of  the  fractures  

has  been  challenged.    Thermal  imaging  has  not  consistently  demonstrated  that  it  

can  accurately  detect   the  difference  between  a   fracture  and  a  soft   tissue   injury  

using  a  target  temperature  of  greater  than  1˚C.  If  thermal  imaging  had  been  used  

to  determine  whether   a   child   received   an  X-­‐ray  or  not,   12  out   of   100   children  

would   receive   needless   X-­‐rays.   These   results   do   demonstrate   a   quantifiable  

difference  between  an  uninjured  limb,  a  fracture  and  a  soft  tissue  injury,  but  the  

results  have  to  be  used  cautiously  as  they  do  not  show  the  differences  on  every  

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examination.  However,  this  study  has  been  conducted  with  a  limited  sample  size  

and  further  studies  would  be  needed  to  validate  these  findings.      

 

Sackett  and  Haynes  (2002)  suggest  that  for  this  study  to  test  the  methodology  in  

order  to  move  onto  a  full  the  phase  III  study  it  must  be  shown  to  be  independent  

and  blind  when  compared  with  the  gold  standard  of  diagnosis.  This  study  meets  

the  criteria   fully  with  all  of   the  patients  undergoing   the  diagnostic   test  and   the  

gold   standard   test   with   the   reference   standard   applied,   regardless   of   the   test  

result.   The   study  was   blinded   in   that   the   reference   standard   test   results  were  

interpreted   in   total   ignorance   to   the   diagnostic   test   results   and   vise-­‐versa  

(Sackett   &   Haynes,   2002,   p.   31).     The   pilot   study   represents   a   significant  

development   into   the   use   of   thermal   imaging   within   the   field   of   diagnostics,  

though   it   highlights   the   need   for   a   standardised   approach   to   thermal   imaging  

within   the   clinical   environment.   This   is   the   first   documented   paper   examining  

the  use  of  thermal  imaging  to  detect  fractures  in  children's  wrist  and  highlights  

its  potential  use  within  health  care.    One  coincidental  finding  from  this  paper  is  

that  the  inclusion  criteria  established  from  research  carried  out  by  Webster  et  al.  

(2005)  confirms  their  finding  that  clinical  decision  rules  used  for  the  detection  of  

fractures  are  not  reliable   in  ruling  out   the  presence  of  a   fracture  and  therefore  

cannot  be  used  to  make  a  clinical  diagnosis  on  their  own.    

6.1  Summary:  

 This   paper   highlights   the   need   for   further   research   into   developing   new  

technology,   which   would   enhance   the   care   and   experience   of   a   certain   client  

groups,  which  could  be  more  cost  effective  and  efficient  in  terms  of  care  delivery.  

    117  

There  is  no  doubt  that  this  thesis  marks  the  infancy  of  thermal  imaging  research  

in  the  area  of  fracture  detection  and  its  use  within  the  clinical  setting.  The  need  

for   a   larger   phase   III   study   is   evident   from   the   published   finding,   and   does  

demonstrate   a   degree   of   success   for   thermal   imaging   to   be   used   to   detect  

fractures  in  children.  The  major  floor  in  the  use  of  thermal  imaging  in  this  way  is  

its   inconsistency   in   practice   and   the   fact   that   it   is   not   100%   reliable   as   a  

diagnostic  tool.      This  paper  has  demonstrated  concerns  over  its  use  within  the  

mainstream  health  care  system,  however  with  further  research  and  mechanical  

advances   into   the   thermal   imaging   technology   the   reliability   and   sensitivity   of  

the  imaging  equipment  may  be  improved.    

 

Key  Findings:    

 • Thermal   imaging   is   not   consistently   reliable   in   detecting   fractures   of   the  

ulna   and   radius   in   children   returning   a   sensitivity   of   only   91.8%  when  

compared   with   x-­‐rays   (96.8%)   however   when   used   along   side   clinical  

examination  the  results  demonstrate  a  sensitivity  of  up  to  96.7%.    

• Thermal   imaging   can   detect   quantifiable   differences   in   temperature,  

between  an  uninjured  wrist,  a  soft  tissue  injury  and  a  fracture.      

• Further   research   needs   to   be   conducted   in   this   area,   and   funding  

established   for   the   development   of   the   theory   surrounding   the   use   of  

thermal  imaging  as  a  future  low  cost,  non-­‐invasive  diagnostic  test.  

• A   full   phase   III   multi   centered   study   must   be   developed   to   establish  

whether   thermal   imaging   could   be   a   useful   adjunct   to   the   diagnosis   of  

fractures  within  the  wider  health  care  setting.  

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6.2  Implication  for  practice    

 Over   four   million   children   attend   Emergency   Departments   annually   (RCPCH  

2012p   9).   Wrist   fractures   account   for   approximately   30%   of   all   attendance's  

(Firmin  &  Crouch,  2009)  to  either  walk  in  centres  or  emergency  departments.  A  

large  number  of  these  are  diagnosed  as  simple  green  stick  or  torus  fractures  that  

could  easily  be  managed  conservatively  within  the  primary  care  setting  (Boyer,  

2002).  Although  this  study  does  not  examine  whether   thermal   imaging  may  be  

useful   out   side   the   emergency   department   boundaries   it   does   provide   the  

researcher   with   information   surrounding   the   challenges   of   using   thermal  

imaging   outside   the   controlled   environment   of   the   emergency   department  

setting.    

 

 This   pilot   study   has   highlighted   that   thermal   imaging   may   be   useful   in   the  

diagnoses   of   fractures   to   the   ulna/radius   in   children  with   reasonable   efficacy.  

The   results   of   this   study   and   previous   audits   carried   out   within   the   clinical  

setting   have   shown   that   up   to   79   children   a   month   attend   the   emergency  

department  due   to  a  painful  wrist.  There   is  no  doubt   that   a   reduction   in   these  

numbers   attending   the   emergency   department   could   be   beneficial   both   to   the  

health  economy  and  patients   themselves   (DOH,  2005;  Cooke,  2005).  All   simple  

wrist   fractures,   unless   clinically   displaced,   could   be   treated   initially   in   the  

community/primary   care   setting   without   the  major   upheaval   of   attending   the  

emergency  department  and  carefully  planned  follow  up  (Ippokratis  et  al.,  2010;  

Symons  et  al.,  2001;  Bosse  et  al.,  2005;  West  et  al.,  2005).  The  advantages  of  a  

community  based  thermal  imaging  center  rather  than  a  fully  equipped  radiology  

    119  

department   is   evident   both   in   terms   of   cost   and   reduced   ionizing   radiation  

exposure   to   the   client   group   involved   (Williamson   et   al.,   2000).   If   patients  

meeting   the   clinical   inclusion   criteria   presented   to   a   walk   in   centre   equipped  

with   a   thermal   imaging   camera,   then   a   thermal   image   could   be   taken   and   a  

decision  made   regarding   the   further   treatment   and   care   of   that   patient  made.  

This  would  result  in  tangible  cost  saving  to  the  health  economy.    

If  proven  clinically  effective  the  cost  of  a  thermal  imaging  camera  with  up-­‐keep  

would  be  less  than  £60,000,  no  special  facilities  need  to  be  built  and  it  could  be  

accommodated  in  a  normal  clinical  space  and  used  by  the  attending  clinician.    

6.3  Dissemination  of  findings:    

 A  paper  is  currently  being  written  for  publication  on  this  thesis  and  its  research  

findings   the  author  wanted   to   complete   the   study  and   thesis  before  publishing  

the   complete   results   of   this   research   study.   The   study   was   presented   at   the  

Wessex  Regional  Emergency  Care  conference  in  Sept  2012  

 

 

 

 

 

 

 

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Chapter  7    

 

 

 

 

 

 

 

 

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Chapter  7:  Reflections  on  the  doctorate  program    

 Formal  reflection  in  terms  of  models  and  set  formulas  has  never  sat  comfortably  

with  me,  as   I  have   found  that   they  do  not  meet  my   individual   learning  style  or  

needs.  However,  it  would  be  naive  of  me  to  think  that  reflection  does  not  play  an  

important  role  in  my  professional  development.  Those  who  know  me  and  work  

with   me   will   know   that   I   spend   a   great   deal   of   time   both   internalising   and  

externalising   clinical   scenarios   to   try   to   improve   practice   or   do   something  

different  next  time,  one  could  argue  that  this  is  a  form  of  ‘reflection  in  action’  as  

described  by  Schon  (1983).  Holm  and  Stephenson  (1994)  expressed  support  for  

this   idea   of   reflection   suggesting   that   there   can   be   no   definitive   rules   and   no  

universally   correct   way   in   which   to   reflect   and   therefore   reflection   must   be  

individually  based  and  individually  relevant.  However,  a  model  I  found  useful  for  

evaluating   and   reflecting   on   educational   programs   during   my   Masters   in  

Education   is   one   devised   by   Gibbs   (1988)   as   it   was   routed   firmly   within  

education   with   emphasis   placed   on   learning.   However,   to   reflect   on   this  

educational   and   professional   program   I   have   decided   to   use   Borton’s   (1970)  

reflective   framework   as   the   model   has   been   developed   around   practice,   and  

allows  the  practitioner  to  explore  the  journey  they  have  embarked  upon  fully.    

 

From  an  early  stage  in  my  career  it  became  apparent  to  me  that  life  long  learning  

was  going   to  be  an   important  part  of  my  career  development  and  progression.  

For  nursing  to  evolve  as  a  profession  it  has  had  to  develop  its  own  unique  body  

of   evidence   and   researched   based   practice   (Jasper,   1999).   Therefore   it   has  

become  increasingly  important  for  nurses  and  professionals  allied  to  medicine  to  

    122  

become   more   professional   and   academically   astute.   This   has   become  

increasingly   difficult,   as   the   blurring   of   professional   roles   and   boundaries   has  

meant   that   the   exclusivity   of   practice   between   the   differing   professions   no  

longer  exists  (Eddy,  1996).  The  main  reason  for  me  to  enroll  on  this  professional  

doctorate  was  that  I  required  an  educational  programme  that  would  support  my  

progression  from  an  emergency  nurse  practitioner/senior  nurse  to  a  consultant  

nurse  in  Paediatric  Emergency  Medicine.  The  Professional  doctorate  appeared  to  

enhance   the   symbiotic   relationship   between   practice   and   academia.   This  

educational   program   appeared   to   be   ideally   suited   to   the   development   of   the  

consultant   practitioner   role.   The   four   elements   of   the   professional   doctorate  

encompass   all   of   the   consultant   practitioner   role,   research,   education,   expert  

practice,   leadership  and  strategic  service  development  (Skills   for  health,  2010).    

The  educational  program  in  my  opinion  is  the  only  programme  available  to  allow  

the  clinician  to  develop  their  own  practice  at  doctorate  level.  The  need  for  me  to  

develop  my  expertise  in  clinical  practice  and  develop  my  post  with  recognisable  

and   established   competences   was   paramount   to   demonstrate   my   clinical  

expertise   as   a   consultant   in   Paediatric   Emergency   Medicine   and   practice   on  

equal  terms  with  my  medical  colleagues  (College  of  Emergency  Medicine,  2007).  

The  professional  doctorate  has  been  divided  into  two  parts  and  is  a  development  

of   the  taught  doctorate  where  the  final  research  thesis   is   focused  strictly  on  an  

element   of   clinical   practice.   The   professional   doctorate   offered   me   the  

professional  development  that   I  required   in  a  way  that  a   traditional  PHD  could  

not.   The   taught   equipped  my   with   the   tools   required   to   take   on   the   research  

element  but  as  described  above  encouraged  me  to  develop  my  clinical  practice.    

The  three  key  areas  in  which  the  taught  program  enhanced  my  practice,    

    123  

Ø The   clinical   Portfolio   of   PEM   competency,   as   part   of   my   professional  

doctorate   clinical   portfolio,   which   took   three   years   to   complete   and  

challenged  my  professional  competence  at  every  level.  

Ø  Advanced   diagnostic   skills,   the   ability   to   perform   ultra   sound   and  

thermal  imaging  investigations  independently.    

Ø Clinical   leadership,   develop   my   skills   to   lead   clinical   scenarios   as   a  

consultant.    

 

This   programme   has   developed   my   thinking   and   knowledge   surrounding   the  

specialty  of  emergency  medicine  encouraging  me  to   think  out  side   the  box  and  

develop  my   practice   further.   Since   embarking   on   the   clinical   doctorate   I   have  

become  part  of  an  editorial   team  for   four  major   texts   in   the   field  of  emergency  

nursing  and  paediatric  emergency  medicine,  the  most  exciting  being  the  Oxford  

Handbook  of  Emergency  Nursing,  which  has  sold  over  6000  copies  and  is  now  in  

development   for   its   second   edition.   There   is   no   doubt   that   the   publications  

module   assisted   me   with   the   development   of   this   title   and   subsequent  

publication.    

 

The  importance  of  the  clinical  element  of  the  Professional  Doctorate  and  it  close  

links   to   advanced  practice  must   not   be   underestimated   or   lost   in   the  world   of  

academia   and   is   the  key   element  of   the   course   that  makes   it   unique   and  more  

credible   in   terms  of  professional  recognition.  Whilst  on   the  course   I  was  called  

upon   to   practice   independently   in   many   differing   clinical   environments   both  

with  in  this  country  and  abroad,  the  clinical  element  of  this  program  meant  that  I  

was  professionally  and  clinically  prepared  for  that  challenge.  I  don't  feel  that  any  

    124  

other  programme  would  have  better  prepared  me  for  the  clinical  challenged  that  

I  faced.    

So  what:  what  was  good  and  what  was  bad  about  the  experience      On   reflection   the   educational   programme   of   the   professional   doctorate   was  

exactly   what   I   required   to   enhance   my   career   and   professional   development  

both  in  terms  of  clinical  and  theoretical  knowledge.  There  is  no  doubt  that  I  have  

found  the  process  extremely  difficult  with  trying  to   juggle  a  full   time  job  as  the  

consultant   lead   in   paediatric   emergency  medicine,   an   army  nurse   in   the  Army  

Reserve   and  my   other   national   and   international   professional   commitments.   I  

thoroughly   enjoyed   my   honorary   consultant   nurse   position   in   St   Mary’s  

Paddington  and  I  am  indebted  to  their  commitment  to  develop  my  professional  

practice  and  clinical  knowledge  in  the  field  of  paediatric  emergency  medicine,  I  

regret   that  due  to  my  own  clinical  commitments   I  was  unable   to  continue  with  

this  practice/  opportunity.    This  experience  enabled  me  to  advance  my  practice  

in   a   progressive   but   safe   environment   away   from   the   challenging   distracting  

environment  of  my  own  work  place.  One  of  the  major  challenges  for  completing  

this   study  was   the   conflicting   time   constraints   imposed   on  me   and   the   lack   of  

education   time   allocated   to  me   over   the   past   5   years.   That   said   I   should   have  

been  a  lot  more  disciplined  with  my  time  and  prioritised  better.    

 

Another  major  challenge  /  threat  to  my  research  project  has  been  the  availability  

of   a   loan   thermal   imaging   camera,   although   the   National   Research   Loan  

Laboratory  lent  me  the  camera  it  was  only  for  a  very  limited  period  and  over  this  

time  the  camera  had  to  be  returned  to  the  manufacturer  due  to  a  breakage.  This  

    125  

became  a  real   issue   in   that   it  meant   that   the  study  was  only  carried  out  over  a  

month  meaning  that  only  67  subjects  where  enrolled  into  the  study.  Attempts  to  

secure  the  camera   for  a   longer   loan  period  were  quashed  due  to   the  closure  of  

the   loan   facility   and   the   lack   of   funding.   For   future   studies,   funding   must   be  

gained   to   purchase   a   research   camera   through   Flir   and   thus   not   rely   on   other  

outside   agencies.   At   the   time   of   developing   the   research   model   the   national  

research   funding   institutes   would   not   provide   funding   for   PHD   or   doctoral  

students,   this   is   currently   not   the   case   and   funding   streams   have   become  

available.  To  enhance  the  study  I  think  I  would  have  included  a  patient  /  parent  

qualitative  questioner  exploring   the  use  acceptability   towards   thermal   imaging  

versus   X-­‐ray.   Anecdotally,   the   end   users   expressed   a   real   interest   in   the   new  

technology   and   expressed   very   positive   attitudes   towards   the   use   of   thermal  

imaging  within  the  clinical  arena.    

 

Although   the   study   results   do   not   present   compelling   evidence   that   thermal  

imaging  can  be  used  equivocally  to  determine  whether  a  child  has  a  fracture  in  

the  wrist   following   injury,   they  do  highlight   the   importance  of   further  research  

into   this   area   of   diagnostics.   The   development   of   improved   thermal   imaging  

technology  over  the  last  decade  has  meant  that  the  imaging  is  more  reliable  and  

reproducible.  I  remain  committed  to  this  technology,  sincerely  believing  that  the  

development  of  this  cost  effective,  non-­‐invasive  form  of  diagnostic  imaging  has  a  

very  promising  future.  

Now  what:  

Following   a   presentation   given   at   the   Wessex   Emergency   Care   Committee  

conference   in   September   2012,   an   expression   of   interest   in   continuing   the  

    126  

research  into  this  topic  has  been  articulated  by  the  chair  of  the  South  of  England  

Children’s  Trauma  Network.  Funding  would  be  needed   to  carry  out  a  phase   III  

multi   centered   trial   into   the   use   of   thermal   imaging   for   the   detection   of  wrist  

fractures  in  children.  I  remain  convinced  that  this  could  be  the  tip  of  the  iceberg  

in   terms   of   diagnostic   imaging   and   further   research   in   to   other   areas   of  

diagnostic   imaging   need   to   be   explored   within   in   the   specialty   of   Children’s  

Emergency   Care.   For   example,   the   detection   of   toddlers   fractures   in   children’s  

lower  limbs,  detect  hip  effusions  and  aid  the  diagnosis  of  appendicitis  in  children  

remains  unexplored,  however,  potential  has  been  shown  in  these  areas.    

 

My   practice   and   clinical   knowledge   will   continue   to   expand   and   I   remain  

committed   to   life-­‐long   learning   and   developing   my   knowledge   and   skills   in  

paediatric   emergency  medicine.   I   feel   that   the   professional   doctorate   is   by   no  

means  the  end  stage  in  my  professional  learning  but  a  new  dawn  in  my  clinical  

practice  and  education.    

 

 

 

 

 

 

 

 

 

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Appendices      

Appendix  1:  Patient  information  leaflet    

Appendix  2:  Patient  consent  forms  

Appendix  3:  Data  collection  form    

Appendix  4:  Ethics  Committee  acceptance  letter    

 

 

 

 

 

 

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Appendix  1:  Patient  information  leaflet                                                                                            

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    148  

Appendix  2:  patient  consent  forms:  1  -­‐  2        

    149  

Portsmouth Hospitals NHS NHS Trust

Consent  Form

Version  2  dated  11/03/08      Patient  ID  for  this  trial:      Name  of  researcher:  Alan  Charters    

                                                                           Detection   of   fractures   in   children   using   thermal  imaging    

as  a  diagnostic  screening  tool      • I  confirm  that  I  have  read  and  understand  the  information                sheet  (version  2  Dated    12/03/08)  for  the  above  study  and  have              had  the  opportunity  to  ask  questions      • I  understand  that  my  participation  is  voluntary  and  that  I                am  free  to  withdraw  at  any  time,  without  giving  any  reason,    

           without  my  medical  care  or  legal  rights  being  affected.  

 

 

• I  understand  that  sections  of  any  of  my  medical  notes  may  be                looked  at  by  responsible  individuals  from  regulatory  authorities    

           where  it  is  relevant  to  my  taking  part  in  research.    

 . • I  agree  that  the  thermal  images  and  x-­‐rays  taken  can  be  used  in                                    this  research    

• I  agree  to  take  part  in  the  above  study.    

 Name  of    participant:      …………………………………………………………..  Date:…………….    Signature:………………………………………………………………………………………………    Name  of  person  taking  consent:………………………………………………….Date:……………    Signature:………………………………………………………………………………………………    Researchers  signature:……………………………………………………………Date:………..…..  

 

 

 

 

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Portsmouth Hospitals NHS NHS Trust

 Patient  ID  for  this  trial:  

Parent  &  participant  (aged  0-­‐15  years)  

Consent  Form    

Name  of  researcher:  Alan  Charters    

Detection  of  fractures  in  children  using  thermal  imaging    as  a  diagnostic  screening  tool    

                                                                                                                                                                                                                   Please  initial  box  

                                                                                                                                                                                                                                                                               Child                            Parent/carer  • I  confirm  that  I  (parent)………………………….have  read  and  

understand  the  information  sheet  (version  12/03/08)                for  the  above  study  and  that  (child)…………………………has                read  the  information  sheet  (version  1  12/03/08  )  and  we                both  have  had  the  opportunity  to  ask  questions.      • We  understand  that  our  participation  is  voluntary  and  that   we                are  free  to  withdraw  at  any  time,  without  giving  any  reason,    

           without  our  medical  care  or  legal  rights  being  affected.  

 

 

• We  understand  that  sections  of  the  medical  notes  maybe                looked  at  by  responsible  individuals  from  regulatory  authorities    

           where  it  is  relevant  to  us  taking  part  in  research.    

   

• I  agree  that  the  thermal  images  and  x-­‐rays  taken  can  be                used  in    this  research                

• We  give  our  permission  for  these  individuals  to  access      (child’s  name)  …………………………………  records  

 

   

   

 

   

 

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• We  agree  to  take  part  in  the  above  study.      Name  of  child:…………………………………………………………    …………Date:…………….    Signature:………………………………………………………………………………………………    Name  of  parent/carer……………………………………………………………..Date:…………….    Signature:………………………………………………………………………………………………    Name  of  person  taking  consent:………………………………………………….Date:……………    Signature:………………………………………………………………………………………………    Researchers  signature:……………………………………………………………Date:………..…..  4  copies  of  form  required  –  1  to  chiAppendix  3:  Version  2  12/03/08                                                                

   

    152  

Appendix  3:  Data  collection  form    

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

    153  

Version 2 12/03/08 Date  ………………………….    Patient  No.  …………………..         Age  …………………………..    Pain  Score  ……………………       Analgesia  given:  Yes  /  No      Inclusion  criteria:                                       (Please  tick  the  boxes  provided)  

o Children under the age of 16 (and / or )

o Complaining of or indicating pain in their wrist

o Obvious swelling and deformity of the wrist

o Child is unable to supinate or pronate their wrist or has severe loss

of function

Consent  gained  by  whom:  please  initial  ………………………………………………………    Temperature  of  room  in  degrees  Centigrade…………………………………………………...      X-­‐ray:  Initial  report    X-­‐ray:  Radiology  report        Treatment  given:        Exclusion Criteria

• Patients that have had topical cream or cosmetics applied to their arm

such as fake tan etc. This can artificially affect the skin temperature and

therefore skew the test results

• Patients who smoke, external environmental factors such as smoking has

be shown to effect skin temperature and therefore skew results

 Thermal  image  to  be  reviewed  at  the  end  of  study  not  on  day  of  x  –ray      Temperature  gradient  of  uninjured  wrist  …………………………………………………..  Temperature  gradient  of  injured  wrist  ……………………………………………………..  Obvious  hot  spot  in  thermal  picture  of  injured  ………………………………………..    

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Appendix  4:  Ethics  Committee  acceptance  letter                                                                                                    

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    156  

       

 

    157