national physiotherapy research network midlands hub july 8 th 2009 1

National Physiotherapy Research Network

Midlands Hub

July 8th 2009

1

Midlands NPRN Contacts

Esther Williamson – Warwick University

e.m.williamson@warwick.ac.uk

Sue Kelly – Birmingham University

s.m.kelly@bham.ac.uk

Chris Carpenter – Coventry University

hsx530@coventry.ac.uk

Nikky Clague – Leicester University

njc36@leicester.ac.uk

Managing Injuries of Neck Trial

(MINT)

Results

3

Background

Identified as a priority and commissioned through the NIHR HTA in 2003

Research question:

“What is the effectiveness and cost effectiveness of active treatment for whiplash?”

4

Whiplash Mechanism of injury – acceleration / deceleration usually in the frontal plane

Whiplash Associated Disorders

The signs and symptoms experienced following a whiplash injury

WAD Grade 0 No neck complaints or signs

WAD Grade I Complaint of pain, stiffness or tenderness, but no physical signs.

WAD Grade II Complaint of pain, stiffness or tenderness, and musculoskeletal signs (decreased range of motion, point tenderness etc).

WAD Grade III Complaint of pain, stiffness or tenderness and neurological signs (decreased or absent deep tendon reflexes, weakness and sensory deficits). Could also have musculoskeletal signs.

WAD Grade IV Fracture or dislocation

Late whiplash syndrome

The presence of pain, restriction of motion or other symptoms six months or more after a whiplash injury, sufficient to hinder return to normal activities such as driving, usual occupation and leisure

Acute WAD

Quebec Task Force 1995

McClune et al 2002; Verhagen et al 2004

Hurwitz et al 2008 – Bone and Joint Decade 2000-2010 Task Force on Neck Pain

Since 1980;

15 reports of non-invasive interventions

2 of invasive interventions

Acute whiplash BJD Task Force

“Despite an explosion of the neck-pain literature including several methodologically sound studies in the past decade, there remains limited or conflicting evidence for most of the therapies commonly given to WAD patients”

15 studies compared to usual care, placebo, sham

- 7 equivalent or worse

- 8 better

Trial Management Team

Prof S Lamb – Clinical Trials/PhysiotherapyDr Simon Gates – Senior Research FellowMark Williams – Clinical Trial co-ordinatorEsther Williamson - Research FellowEmma Withers – Trial Co-ordinatorProf M Underwood – MusculoskeletalProf M Cooke – ED Prof D Ashby - StatisticianShahrul Mt Isa - StatisticianDr S Joseph – Psychologist/TraumaEmanuela Castelnuovo - Health Economics

Aims of MINT

1. To estimate the clinical effectiveness of a stepped care approach over a 12 month period after an acute injury.

2. To estimate the costs of each strategy including treatment and subsequent health care costs over a period of 12 months and to estimate cost effectiveness.

Study Design

Stage 1: Emergency Department Treatment:

Psycho educational booklet

(Whiplash Book)

versus

Usual ED Advice

Stage 2: Physiotherapy Management:

Specially designed early intervention by a physiotherapist

Versus

Advice session only

10

Study design - overview

Acute Whiplash Injury presents to ED N= 12 clusters (n≈ 3000 participants)

Whiplash Book advice (WBA)N= 6 clusters

Review and randomisation in research clinic

Physiotherapy & WBA

n=150

Re-enforcement

of WBAn=150

Usual Care Advice (UCA)N= 6 clusters

Review and randomisation in research clinic

Physiotherapy & UCA

n=150

Re-enforcement

of UCAn=150

Outcomes

• Followed up at 4, 8 and 12 months post injury• Postal questionnaire:

Disease specific measure - Neck Disability Index

Generic Health Related Quality of Life (SF12)

Health economics – (health care costs NHS, individual, third party; work; out of pocket expenses; Insurance payouts)

• Qualitative study – interviews of purposive sample 20 pts

12

Eligibility

Sustained a whiplash injury within the last 6 weeks

WAD Grade I – III with neck symptoms

Over 18 years old

No fractures/dislocations of the spine or other bones.

No head injuries with more than a transient loss of consciousness or GSC ≤ 12 at any stage.

Not admitted

No severe psychiatric illness

13

Stage 1: ED training

Usual Care Advice ED staff received training primarily about referring patients to trial

In contrast to

Whiplash Book Advice ED staff received more extensive training to promote key messages

The Whiplash Book

• Positive messages about prognosis, promoting the message that pain is nothing to worry about.

• Promotes early return to normal activities and work.

• Make recommendations about physical activity, exercise and self-management of symptoms.

• Advice against using a collar• Does not include information on pursuing claims

or sponsorship from solicitors.

Trial progress

Developed trial materials November 2004

Pilot study completed August 2005

Launched main trial December 2005

Recruitment completed October 2007

Follow up completed December 200816

12 NHS Trusts

Usual Care Advice

15 Emergency Departments (ED’s) Whiplash Book Advice

Eligible & Enrolled Eligible & Enrolled

1598 2253Median cluster size = 265

(range 55-431)Median cluster size = 332

(range 130-711)

Followed up = 1488 (93%) Followed up = 2042 (91%)

Lost = 115 Lost = 198

Withdrawn = 39 Withdrawn = 46Median cluster size = 248

(range 50-401)Median cluster size = 306

(range 118-642)

Followed up = 1295 (81%) Followed up = 1774 (79%)

Lost = 106 Lost = 171

Withdrawn = 37 Withdrawn = 36Median cluster size = 217

(range 45-349)Median cluster size = 282

(range 113-524)

Followed up = 1175 (74%) Followed up = 1570 (70%)

Lost = 152 Lost = 208

Withdrawn= 22 Withdrawn = 17Median cluster size = 196

(range 38-323)Median cluster size = 262

(range 102-437)

Followed up = 1127 (71%) Followed up = 1577 (70%)Median cluster size = 199

(range 40-305)Median cluster size = 259

(range 91-474)

4 months

8 months

12 months

2 weeks

Results : Stage 1Characteristics (n=3851)

UCA WBA

Number enrolled 1598 2253

Gender – Males 666 (42%) 995 (44%)

Age in years, Mean (SD) 37 (13) 37 (13)

Ethnic Group

White 1336 (84%) 1586 (70%)

Mechanism of injury

Road Traffic Accident 1495 (94%) 2127 (94%)

Location of pain

C-spine only 1046 (65%) 1365 (61%)

Pain intensity (/10), mean (SD) 4.9 (1.9) 5.3 (1.9)

History

Previous neck problems 77 (4.8%) 119 (5.3%)

WAD grades³

I: Complaints of pain, stiffness or tenderness, no physical signs

883 (55%) 1205 (53%)

II: Complaint of pain, stiffness or tenderness, musculoskeletal signs

662 (41%) 997 (44%)

III: Complaint of pain, stiffness or tenderness, neurological signs

53 (3.3%) 51 (2.3%)

Results – Stage 1Primary Outcome - NDI

10

12

14

16

18

20

22

24

4m follow up 8m follow up 12m follow up

UCA

WBA

Ne

ck D

isa

bili

ty I

nd

ex

(%)

Points are offset for visual purposes only

Results – Stage 1 Secondary Outcome – SF12

35

40

45

50

Baseline 4m follow up 8m follow up 12m follow up

UCA

WBA

SF

-12v

1 M

CS

Points are offset for visual purposes only

35

40

45

50

Baseline 4m follow up 8m follow up 12m follow up

UCA

WBA

SF

-12v

1 P

CS

Points are offset for visual purposes only

Results – stage 1 Qualitative Study

From the accounts given, participants received the same verbal advice at both WB and UC centres.

Those who received the Whiplash Book were more likely to have started doing the exercises on their own.

 However, some participants in both groups expressed hesitation about doing exercises without further guidance or reassurance due to worry of doing damage or the wrong thing.

Participants appeared to mainly focus on the exercises suggesting that those receiving the WB did not utilise the other information contained in it.

Stage 1 - Conclusions

• The Whiplash Book delivered in an ED setting was no more effective than the usual care that is delivered.

• No change of practice but is this enough???

Questions

STAGE 2

Study design - overview

Acute Whiplash Injury presents to ED N= 12 clusters (n≈ 3000 participants)

Whiplash Book advice (WBA)N= 6 clusters

Review and randomisation in research clinic

Physiotherapy & WBA

n=150

Re-enforcement

of WBAn=150

Usual Care Advice (UCA)N= 6 clusters

Review and randomisation in research clinic

Physiotherapy & UCA

n=150

Re-enforcement

of UCAn=150

Stage 2: Physiotherapy

Inclusion criteria:

Still experiencing symptoms approximately three weeks after attendance at the ED

Had symptoms in the last 24 hours

WAD grade I-III at this time

Did not have any contra-indications to physiotherapy: central cord compression or upper motor neuron lesion, complete nerve root compression or lower motor neuron lesion, suspected vascular injury or haemorrhagic event.

Physiotherapy package

An assessment

Up to 6 treatment sessions

Designed to be delivered over approximately 8 week period

Development of physiotherapyintervention

Patient group:Whiplash associated disorders

I-III Phase of recovery:

Sub-acute – referred for treatment between 3 and 6 weeks post

injury

Current physiotherapy

practice

Risk factors for poor outcome following a

whiplash injury

Acceptable to clinicians

Existing clinical practice

guidelines

The setting: deliverable in

the NHS

Standardised and reproducible to allow

evaluation

Current evidence base: effective

treatments

Intervention design

considerations

Theoretical basis for physiotherapy intervention

Risk Factor Modification

“ Variable with significant association with a clinical outcome”

Identify risk factors

Target treatments to modify these factors

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Physical risk factors

High initial pain and disability

The literature also suggested that addressing reduced ROM, altered muscle function and control may be beneficial.

Psychological risk factors

Low self-efficacy

Post traumatic stress reaction

The literature also suggested that addressing fear avoidance, catastrophising, coping and distress may also be beneficial.

Physiotherapy package

Integrated approach to the management of both physical and psychological factors utilising three main components:

1. manual therapy

2. exercise

3. psychological strategies and self-management advice.

Control Intervention

40 min session

No hands on

Reinforcement of ED advice

Questions and Answers

33

Treatments delivered (n=599)Advice

N (% of stage 1)Physiotherapy

N (% of stage 1)

Usual Care AdviceCoventry & Rugby 30 (8%) 31 (8%)Frenchay 18 (8%) 16 (7%)Cheltenham & Gloucester 40 (9%) 39 (9%)Redditch 24 (8%) 25 (8%)Kettering 15 (7%) 14 (7%)Stoke Mandeville 3 (5%) 5 (9%)

Whiplash Book AdviceHeartlands & Solihull 47 (7%) 48 (7%)Selly Oak 29 (6%) 27 (5%)John Radcliffe Hospital 21 (9%) 23 (10%)Warwick 25 (10%) 25 (10%)Gwent 14 (11%) 15 (12%)Chester 21 (5%) 19 (5%)

Attendance rates

Physiotherapy Package (n=300)

Advice session (n=299)

Failed to attend any appointments

34(11%) 60 (20.1%)

Attended for assessment only

26 (9%) N/A

Partial completion of treatment

45 (15%) N/A

Completed treatment 201(67%) 239 (79.9%)

Treatments deliveredNumbers of treatment

Physiotherapy Package

Range = 0 to 23 (Median = 3.0, IQR = 1.0 -5.0)

14 (4.7%) patients receiving greater than the recommended six treatment sessions.

Timings of treatment:

Physiotherapy package:

63% of patients were seen within 2 weeks of referral.

91% were seen within 4 weeks of referral

62% of patients completed their treatment in the recommended eight weeks

87% of patients completed within 12 weeks

Physiotherapy delivered

Combinations of treatments deliveredNumber of patients receiving the treatment (%)

Manual therapy, exercises and psychological strategies

190 (73%)

Exercises and psychological strategies 45 (18%)

Manual therapy and psychological strategies 10 (4%)

Manual therapy and exercises 9 (4%)

Manual therapy only 2 (1%)

Exercises only 2 (1%)

Psychological strategies only 1 (0.5%)

Timings of treatment:

Advice session:

53% of those receiving the advice session were seen within 2 weeks of referral.

86% attended within 4 weeks

Advice givenContents of advice session Number of

patients (%)Assessed ROM 232 (97)Reviewed exercises given in the ED 228 (95)Advised to see their GP if they had ongoing problems 220 (92)Postural or positioning advice 200 (83.5)Advice re: pain control or medication use 185 (77.5)Reinforced the “hurt does not equal harm” message¹ 121(50.5)Advice re: graded return to activities, return to work or staying active¹

119 (50)

Reassurance¹ 119 (50)Progressed exercises within the guidelines of WB¹ 108 (45)Neurological examination 87 (36.5)Relaxation techniques¹ 82 (34.5)Advice re: collar 56 (22)Other advice 25 (8.4)Referred on due to serious complication 2 (0.8)

Follow up

Follow up rates

4 month follow up 88%8 month follow up 89%12 month follow up 86%

Results – stage 2 Characteristics

More Females (64%)

Mean age 40 yrs

WAD grades: I = 46%

II = 49%

III = 4%

Results – Step 2 – NDI scores

15.0

20.0

25.0

30.0

35.0

40.0

45.0

50.0

Baseline 4m follow up 8m follow up 12m follow up

Advice Physio

ND

I o

vera

ll sc

ore

(%

)

Points are offset for visual purposes only

Results – Step 2

• Physiotherapy intervention provided a greater reduction in NDI scores (by about 3% points) at 4 month follow up.

• The difference was not retained at 8 and 12 month follow-ups.

• This symptomatic relief may be very important to the individual but was not demonstrated to be cost-effective at a health service level.

Results – Step 2 – SF-12

35

40

45

50

Baseline 4m follow up 8m follow up 12m follow up

Advice

Physio

SF

-12v

1 M

CS

Points are offset for visual purposes only

35

40

45

50

Baseline 4m follow up 8m follow up 12m follow up

Advice

Physio

SF

-12v

1 P

CS

Points are offset for visual purposes only

Levels of disability

4 monthsN(%)

8 monthN (%)

12 monthsN(%)

No disability 66(13.5) 120(25.2) 151(32.9)

Mild disability 215(44.0) 199(41.7) 172(37.5)

Moderate disability 142(29.0) 114(23.9) 102(22.2)

Severe disability 51(10.4) 35(7.3) 28(6.1)

Complete disability 15(3.1) 9(1.9) 6(1.3)

Total 489(100) 477(100) 459(100)

Qualitative study – stage 2

Participants receiving the Physiotherapy Package highlighted the helpfulness of the guidance and reassurance received, particularly in relation to undertaking exercises, and the manual therapy.

A minority of those receiving the physiotherapy package felt they needed more treatment.

Qualitative study – stage 2

The advice session also provided guidance and reassurance that enabled participants to manage their injury and in particular undertake the exercises suggested in the written advice.

This single session was sufficient for many participants especially when access was relatively quick, although, some participants felt they would have benefited from a follow up session

Overall conclusions

A physiotherapy package based on manual therapy, exercise and psychological strategies and self-management advice results in short term benefit, but no difference in longer term outcomes.

At the population level there is residual disability at 12 months, this needs more careful exploration.

Non-invasive Interventions for Whiplash-Associated Disorders

Likelihood of Being Helpful in the Short Term:

Likely helpful (worth considering)

Possibly helpful (might consider)

Likely not helpful (not worth considering

Not enough evidence to make determination

1. Educational video2. Mobilization3. Exercises4. Mobilization and

exercises

1. Pulsed electromagnetic therapy

1. Pamphlet/neck booklet alone

2. Collars3. Passive modalities

(heat, cold, diathermy, hydrotherapy)

4. Referral to fitness or rehab program

5. Frequent early health-care use

6. Methylprednisolone

1. Manipulation2. Traction 3. NSAIDS4. Other drugs

The Bone and Joint Decade 2000 –2010 Task Force on Neck Pain and Its Associated Disorders

What do these results mean?

NHS manager

Clinician

Whiplash researcher

Patient

ReferencesHurwitz et al (2008) Treatment of neck pain: non invasive interventions:

results of the bone and joint decade 2000-2010 Task Force on Neck Pain and it’s associated disorders. Spine 2008: 33(4 suppl):s123-52.

Williamson et al (2009) Development and delivery of a physiotherapy intervention for the early management of whiplash injuries: The Managing Injuries of Neck Trial (MINT) Intervention. Physiotherapy 95(1):15-23

Williamson et al (2008) A systematic literature review of psychological factors and the development of late whiplash syndrome. Pain 135(1-2): 20-30

 Williams et al (2007) A systematic literature review of physical factors and the development of late whiplash syndrome. Spine 32(25): E764-E780

 Lamb et al (2007) Managing Injuries of the Neck Trial (MINT): design of a randomised controlled trial of treatments for whiplash associated disorders. BMC Musculoskeletal Disorders 2007, 8:7  

MINT Incentive Study

Results

Background

Postal Questionnaires are commonly used in RCT’s to collect data

Non-response -> missing data -> bias?Postal and telephone chasing is labour

intensiveMonetary incentives have been shown to be

effective in non-healthcare settingsEffectiveness in healthcare settings

uncertain…

Methods

RCT of a £5 gift voucher vs. no gift voucher

Eligibility: MINT Participants who were sent a follow-up Q at either 4 or 8 months post injury

Questionnaire 15 pages with 49 questions

Standard Chasing strategy was used

Results

2144 randomised (1070:1074)

Higher proportion of Q’s returned in incentive group (810 vs.738) (RR 1.10 [1.05, 1.16])

Higher proportion of Q’s returned without chasing in incentive group (560 vs.493) (RR 1.14 [1.05, 1.24])

Cost £67.29 per additional questionnaire returned

Conclusions

Monetary incentives may be an effective way to increase proportion of postal questionnaires returned and minimise loss to follow-up in healthcare trials.

Further studies needed to investigate the effect of size of incentive, conditional vs unconditional and timing of incentive.

Questions