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Systematic Review: Injection of Steroid to the Iliotibial Band Prepared for: Amanda Bowens, Information Specialist The Accident Compensation Corporation PO Box 242 Wellington 6011 New Zealand Prepared by: International Centre for Allied Health Evidence University of South Australia Adelaide SA 5000 Australia Systematic Review of the Literature The effectiveness of injection of steroid with or without local anaesthetic to the iliotibial band

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Page 1: Systematic Review of the Literature - acc.co.nz · mobilisation, foam roller, strengthening, cryotherapy, education, foot orthoses and surgical interventions of percutaneous and open

Systematic Review: Injection of Steroid to the Iliotibial Band

Prepared for: Amanda Bowens, Information Specialist The Accident Compensation Corporation PO Box 242 Wellington 6011 New Zealand Prepared by: International Centre for Allied Health Evidence University of South Australia Adelaide SA 5000 Australia

Systematic Review of the

Literature

The effectiveness of injection of steroid

with or without local anaesthetic to the

iliotibial band

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RESEARCH CENTRE RESPONSIBLE FOR THE PROJECT

International Centre for Allied Health Evidence School of Health Sciences City East Campus University of South Australia Adelaide South Australia 5000 Website: www.unisa.edu.au/cahe Review team Daniella Dougherty Steve Milanese Karen Grimmer Ashley Fulton Holly Bowen Heath Pillen Emile Sach Emily Menesdorff Centre Director Professor Karen Grimmer Phone: (08) 8302 2769 Fax: (08) 8302 2766 Email: [email protected]

Project administrator Ms. Madeleine Mallee Business Services Officer Business Development Unit Division of Health Sciences University of South Australia Phone: (08) 8302 2121 Fax: (08) 8302 1472 Email: [email protected] Citation details

The International Centre for Allied Health Evidence (2016) Systematic Review of

Literature: The Effectiveness of Injection of Steroid with or without Local

Anaesthetic to the Iliotibial Band: Technical Report. Prepared for the Accident

Compensation Corporation, New Zealand.

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Table of Contents

Contents Executive Summary ..................................................................................................................... 5

1. Background .............................................................................................................................. 6

1.1 Objective of this review ................................................................................................................ 6

1.2 Description of the Intervention..................................................................................................... 6

2. Methodology .......................................................................................................................... 8

2.1 Review question .......................................................................................................................... 8

2.2 Methods ....................................................................................................................................... 8

2.3 Search strategy ............................................................................................................................. 8

2.4 Study Selection ............................................................................................................................. 9

2.5 Critical Appraisal ........................................................................................................................ 10

2.6 Data Extraction ........................................................................................................................... 10

2.7 Data Synthesis ............................................................................................................................ 11

2.8 Grade of Recommendation ........................................................................................................ 12

3. Results ................................................................................................................................... 13

3.1 Evidence Sources ........................................................................................................................ 13

3.2 Quality of the Evidence ............................................................................................................... 13

3.3 Outcome Measures – Pain and Function ................................................................................... 14

3.4 Outcome Measures – Safety and Risk ........................................................................................ 15

3.5 Economic analysis ...................................................................................................................... 15

4. Recommendations ................................................................................................................. 16

5. References ............................................................................................................................. 17

6. Appendices ............................................................................................................................ 19

Appendix 1 – SIGN checklists used in this review ............................................................................. 19

Appendix 2 – Quality scores for articles used in this review ............................................................ 22

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Abbreviations The following abbreviations are used in this report and are collated here for readers convenience

Abbreviation ITB Iliotibial Band RCT Randomised Controlled trial ITBS Iliotibial Band syndrome SIGN Scottish Intercollegiate Guidelines Network

NSAIDs Non-Steroidal Anti-Inflammatory Drugs SR Systematic Review PICO Population, Intervention, Comparator,

Outcome

PLA2 Phospholipase A2

Quality Ratings AQ Acceptable Quality LQ Low Quality CS Can’t say NA Not Applicable HQ High Quality R Reject (Unacceptable Quality) QS Quality of Study

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Executive Summary

Objective of the

Review

The objective of this systematic review is to synthesise the evidence related to the

effectiveness of injection of steroid to the iliotibial band as a form of interventional pain

management.

In order to review the evidence this review aims to answer the following research questions:

1. What is the evidence for the effectiveness of steroid injections into the iliotibial band in

relieving pain and/or in improving functional outcomes in patients with pain?

2. What is the evidence for the safety of steroid injections into the iliotibial band

Evidence sourced

The search yielded 75 articles. After scrutiny, 71 articles were excluded as duplicates or failing

to meet the inclusion criteria, leaving four (4) studies for inclusion in this review including one

(1) randomised controlled trial (RCTs), one (1) case series, and two (2) case studies.

What is the

evidence for the

effectiveness of

steroid injections

into the Iliotibial

Band in relieving

pain and/or in

improving

functional outcomes

in patients with

pain?

The evidence suggests that local infiltration with corticosteroids decreased pain during

running more so than placebo after 14 days (Level C Recommendation based on 1 x HQ RCT

and 1 x AQ Case series).

What is the

evidence for the

safety of steroid

injections into the

Iliotibial Band

The evidence suggests that the risk of complications associated with steroid injections into

the iliotibial band are rare and may be associated with repeated injections. (Level D

Recommendation based on 1 x Case study).

Does the evidence

report any

information about

cost effectiveness?

Evidence is lacking on the economic value of using steroid injections to the iliotibial band as

an inteventional pain management technique.

Compared to 2005

Recommendations There are no 2005 recommendations to compare current review findings with.

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1. Background

1.1 Objective of this

Review

The objective of this review was to synthesise the evidence related to the effectiveness of

injection of steroid with or without local anaesthetic to the iliotibial band (ITB) as a form of

interventional pain management. This review carried out a systematic review of the best

available research evidence.

This review aimed to answer the following research questions:

a) What is the evidence for the effectiveness of steroid injections into the iliotibial band with

or without local anaesthetic is relieving pain in patients with Iliotibial Band or associated

pain

b) What is the evidence for the effectiveness of steroid injections with or without local

anaesthetic in improving functional outcomes in patients with iliotibial band or

associated pain?

c) What is the evidence for the safety of steroid injections with or without local anaesthetic

in patients with iliotibial band or associated pain?

1.2

Description of the Intervention

The iliotibial band (ITB) is a thick fascial band that forms proximally from the iliac crest,

continues down the lateral aspect of the thigh, passing over the lateral femur epicondyle to

divide into the iliopatella band and the distal extension of the ITB to attach to the lateral

condyle of the tibia and the lateral aspect of the patella (Birnbaum et al. 2004, Muhle et al.

1999, Orava 1978).

The ITB itself can be a structure associated with pain (Michels et al. 2008, Lavine 2010) and it

is also associated with a range of pathologies that contribute to hip, knee and thigh pain. These

include iliotibial band syndrome (ITBS), which is the most common cause of lateral knee pain

presenting in athletes (Strauss et al. 2011, Ellis et al. 2007, Fredericson & Wolf 2005, Khound &

Flynn 2005, Taunton et al. 2002), and greater trochanteric bursitis, which is associated with

‘snapping hip’ syndrome that is caused by the ITB sliding over the greater trochanter (Williams

and Cohen 2009, Allen & Cope 1995). This report will focus on the use of steroid in the

treatment of ITBS.

It was previously thought that the bursae related to the ITB became inflamed due to friction.

However, recent studies have hypothesised that the bursae are not inflamed but inflammation

is limited to the fibrous attachments to the femur and the surrounding fat (Michels et al. 2008,

Lavine 2010). Regardless of the structure irritated, inflammation, which causes pain and tissue

degeneration, is commonly a factor underlying these clinical diagnoses.

Based on these observations many treatments have been promoted for treatment of ITB pain

and its associated conditions. These include surgical and non-surgical options, such as; activity

modification, rest, equipment modification, oral non-steroidal anti-inflammatory drugs

(NSAIDs), corticosteroid injections, physical therapy incorporating stretching, soft tissue

mobilisation, foam roller, strengthening, cryotherapy, education, foot orthoses and surgical

interventions of percutaneous and open surgical release of the ITB, ITB Z-lengthening,

bursectomy and an arthroscopic technique to treat refractory ITBS (Strauss et al. 2011).

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Steroids – Rationale

Locally, corticosteroids act to inhibit the inflammatory response induced by mechanical,

chemical, or immunologic agents. This inhibition occurs in specific leukocyte functions,

including leukocyte aggregation at inflammatory sites, prevention of degranulation of

granulocytes, mast cells, and macrophages, and stabilization of lysosomal and other

membranes (Di Rosa et al 1986). Corticosteroids also inhibit PLA2 activity, therefore

interrupting the arachidonic acid cascade. It has also been shown that local application of

cortisone blocks transmission in normal nociceptive C-fibres, potentially blocking nociceptive

nerves in the manner of local anaesthetics.

Several different steroid preparations may be used, with or without local anaesthetic or normal

saline to increase the volume of the injectate. Typical steroids used include

methylprednisolone acetate, betamethasone acetate/propionate, and triamcinolone acetate.

The benefits of adding a local anaesthetic include potential immediate pain relief for the

patient which provides feedback to the practitioner that the steroid solution is near the

presumed site of pathology.

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2. Methodology

2.1 Review question

What is the effectiveness of injection of steroid with or without local anaesthetic to the iliotibial

band?

2.2 Methods

A systematic review of published research literature was undertaken to provide a synthesis of

the currently available research evidence related to the effectiveness of iliotibial band (ITB)

steroid injections with or without local anaesthetic as a form of interventional pain

management. A systematic and rigorous search strategy was developed to locate all published

and accessible research evidence. The evidence base for this review included research evidence

from existing systematic reviews, meta-analyses, and high-level primary research (randomised

controlled trials, prospective cohort studies). Where no systematic reviews, randomised

controlled trials, or prospective cohort studies were located then other primary study designs

(excluding commentary /expert opinion) were considered.

2.3 Search strategy

The search was developed using a standard PICO structure (shown in Table 1). Only English

articles published, using human participants, which were accessible in full text were included.

Table 1: Criteria for considering studies in the review

Population Humans

Intervention Steroid injection with or without local anaesthetic as a form of interventional pain management

Comparator Any active treatment or placebo.

Outcomes

• Pain-related primary outcome; • Functional outcomes (range of motion, reduction of disability,

return to work, quality of life) • Safety and Risk • Relationship to Imaging • Best Practice recommendations • Cost effectiveness

A combination of search terms (shown in Table 2) were used to identify and retrieve articles in

the following databases:

o OVID

EMBASE,

MEDLINE,

AMED, o ICONDA, o CINAHL,

o PubMed, o Pre-Medline, o The Cochrane Library, o Scopus, o TRIP database

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Table 2: Search terms for the review

Search term 1

Search terms 2 Search terms 2 Search terms 3

• Pain • Injections

.

Iliotibial band

ITB

Iliotibial band pain syndrome

• Steroid • Betamethasone • Dexamethasone • Fluocortolone • Methylprednisolone • Paramethasone • Prednisolone • Prednisone • Triamcinolone • Hydrocortisone • Cortisone • Methandrostenolone • Stanozolol • Methenolone • Oxymetholone • Oxandrolone • Nandrolone • Diflucortolone • Fluprednisolone

The titles and abstracts identified from the above search strategy were assessed for eligibility

by the iCAHE researchers. Full-text copies of eligible articles were retrieved for full

examination. Reference lists of included full-text articles were searched for relevant literature

not located through database searching.

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2.4 Study Selection

Inclusion Criteria

• Study types: Systematic reviews, all primary research designs (randomised controlled trials (RCTs), cohort studies (prospective or retrospective), case studies or case series.

• Participants: Patients with lower limb pain related to ITB

• Intervention: Steroid injections with or without local anaesthetic

• Controls: Any active treatment or placebo, or no intervention control

• Outcomes: Pain relief (primary) functional outcomes, safety, and risk (secondary)

• Publication criteria – English language, full text available, in peer reviewed journal

Exclusion criteria

• Studies only available in abstract form E.g. conference presentations

• Grey literature and no-English language material

• Studies involving healthy volunteers or experimentally induced pain

2.5 Critical Appraisal

The SIGN (Scottish Intercollegiate Guidelines Network) checklist specific to the study design of

the included studies was used to assess the methodological quality of the included studies. The

SIGN checklist asks a number of questions with yes, no, can’t say or not applicable as responses

with the appraiser giving an overall rating of quality, based on the responses to questions of

either high quality (++), acceptable (+), low quality (-) or unacceptable. As there is no SIGN

Checklist for case studies these study designs will not be quality scored by using a SIGN

Checklist, however as per the recommendations of the client, a checklist for Case Series study

designs presented Young et al (1999) will be used. Appendix 1 contains a copy of the SIGN

checklists utilized in this study and the copy of the Young et al (1999) checklist.

2.6 Data Extraction

Data were extracted from the identified publications using a data extraction tool which was

specifically developed for this review. The following information were extracted from

individual studies:

Evidence source (Author, date, country)

Level of evidence

Characteristics of participants

Interventions

Outcome measures

Results

For this review the studies that met the inclusion criteria were assessed for internal validity

using the Scottish Intercollegiate Guidelines network (SIGN) Checklist for the relevant study

design. Each study was graded for overall methodological quality using the SIGN Levels of

evidence model.

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2.7 Data Synthesis

As described, for this review each study was graded for overall methodological quality using

the SIGN checklist specific to the study design of the included studies.

Recommendations from the literature were made and scored according to a modification of

the SIGN Evidence Grading matrix (see Table 3). The modification was to add levels 1 and 2 to

differentiate between the 1+ and 1-, 2+ and 2- levels of evidence.

Table 3: Modified SIGN Evidence Grading Matrix

Levels of scientific evidence 1++ High-quality meta-analyses, high-quality systematic

reviews of clinical trials with very little risk of bias

1+ Well-conducted meta-analyses, systematic review of clinical trials or well-conducted clinical trials with low risk of bias

1 Meta-analyses, systematic review of clinical trials or clinical trials with a moderate (acceptable) level risk of bias.

1- Meta-analyses, systematic reviews of clinical trials or clinical trials with high risk of bias.

2++ High-quality systematic reviews of cohort or case and control studies; cohort or case and control studies with very low risk of bias and high probability of establishing a causal relationship

2+ Well-conducted cohort or case and control studies with low risk of bias and moderate probability of establishing a causal relationship

2 Cohort or case and control studies with moderate risk of bias and potential risk that the relationship is not causal.

2- Cohort or case and control studies with high risk of bias and significant risk that the relationship is not causal.

3 Non-analytical studies, such as case reports and case series.

4 Expert opinion.

To standardise the strengths of recommendations from the extensive literature used for this

review a structured system was developed to incorporate a number of quality measures. Four

measures were selected as important variables for the assessment of strength of

recommendations from the primary and secondary research sources. These were:

a) Combination of data via meta-analysis

b) Quality of systematic review/Trials

c) Number of RCTs

d) Consistency of the evidence

A scoring system was developed, based on a 0 and 1 score for each of these variables.

1. Combination of data via meta-analysis: Yes = 1, No = 0

2. Quality of systematic review: HQ/Acc (+) =1, LQ(0)/R = 0

3. Number of RCTs: ≥ 5RCTs = 1, < 5=0

4. Consistency: ≥ 75% agreement = 1, < 75% agreement = 0

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This allowed for a maximum potentials core of 4 and a minimum score of 0, which reflected a

measure of the evidence strength across a range of studies. The resultant score was transferred

to the SIGN Evidence Grading matrix.

Total Score SIGN Evidence Grading matrix score

4 1++

3 1+

2 1

1/0 1-

2.8 Grade of

Recommendations

Final recommendations were graded according to the Scottish Intercollegiate Guidelines

network (SIGN) Grades of Recommendations (Table 4).

Table 4: Scottish Intercollegiate Guidelines network (SIGN) Grades of

Recommendations

Grades of Recommendations

A

At least one meta-analysis, systematic review or clinical trial classified as 1++ and directly applicable to the target population of the guideline, or a volume of scientific evidence comprising studies classified as 1+ and which are highly consistent with each other.

B

A body of scientific evidence comprising studies classified as 2++, directly applicable to the target population of the guideline and highly consistent with each other, or scientific evidence extrapolated from studies classified as 1++ or 1+.

C

A body of scientific evidence comprising studies classified as 2+, directly applicable to the target population of the guideline and highly consistent with each other, or scientific evidence extrapolated from studies classified as 2++.

D Level 3 or 4 scientific evidence, or scientific evidence extrapolated from studies classified as 2+

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3. Results

3.1 Evidence Sources

The search yielded 75 articles; following removal of duplicates 36 articles were identified for

screening of title and abstract. After scrutiny, 32 articles were excluded for failing to meet the

inclusion criteria (shown in Figure 1), leaving 4 studies for inclusion in this review. Figure 1

illustrates the process involved in study selection.

Figure 1: Flow chart of search results

Due to the limited number of articles returned in the search, articles of any age and design

were included within this review.

3.2 Quality of the

Evidence

The overall quality of the studies included in this review ranged from high quality to low quality.

The randomised controlled trial was of high quality (HQ++); however the quality of the case

series and case studies were low to acceptable quality.

The overall quality of the studies included in this review ranged from high quality to low quality.

N= HQ(++) AQ(+) LQ(-)

RCTs 1 1 0 0

Case series/case studies 3 0 2 1

Appendix 2 presents the critical appraisal scores for the studies included in this review.

N=36

N=4 SR =0

RCT= 1 Cohort=0

Case Control=0 Case study/series= 3

EMBASE n= 38 MEDLINE n= 10 AMED n= 0 ICONDA n= 0 CINAHL n= 1 PubMed n= 10 Pre-Medline n=0 Cochrane Library n= 8 Scopus n= 8

N=75

Duplicates removed

Failed to meet

inclusion criteria

from review of

abstract

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3.3 Outcome Measures – Pain and Function

As there was no 2005 review available no date limit was placed on the studies reviewed in this

systematic review.

Systematic Reviews

No systematic reviews into the effectiveness of steroid injections for iliotibial band were found

during the database or reference list searches.

Randomised Controlled Trial

Gunter and Schwellnus (2004) investigated the efficacy of a local corticosteroid injection in the

iliotibial band (ITB) for decreasing pain during running for runner with ITB friction syndrome.

Researchers randomised 18 runners with ITB friction syndrome into two groups. The

experimental group received an injection of 40mg methylprednisolone acetate, while the

control group received an injection of a placebo into the space between the lateral femoral

condyle and the ITB. Authors concluded that local infiltration with corticosteroids decreased

pain during running more so than the placebo after 14 days; the most significant results in this

study were in the period from day 7 to day 14.

Study QS Conclusions

Gunter and Schwellnus

(2004) HQ (++)

40mg methylprednisolone acetate injected into the space between the lateral femoral condyle and the Iliotibial band is effective in reducing pain during running after 7 days.

Rest from running alleviated daily pain in both groups in the 14 day testing period

Case Series

Noble (1980) described the outcomes of a variety of treatments for ITB friction syndrome in

runners, including local steroid injections. Researchers assessed 100 consecutive runners’

knees with ITB friction syndrome with 73 being available for follow up. Steroid injections were

provided for acute condition and for persistent symptoms at 2 week intervals until pain had

completely resolved. The authors described that in 30 patients pain symptoms resolved with

the initial local steroid injection (and reduction in training load), 21 patients resolved after the

second injection and 8 others resolved after the third injection.

Study QS Conclusions

Noble (1980) 1.5/3

Local steroid injections can reduce symptoms of pain in runners with iliotibial band friction syndrome in combination with decreased training load

Multiple local steroid injections can increase the efficacy of decreasing the symptoms of pain in combination with decreased training load

Case Study

Hong and Kim (2013) described the outcome of a local steroid injection with anaesthetic on a

female with ITB friction syndrome. A 64 year old female who hadn’t previously responded to

oral medications or stretching exercises was injected with triamcinolone 20mg and 1ml 1%

lidocaine, under ultrasound guidance, to an area beneath the ITB. The authors concluded that

from an original pain score of 7-8/10 of the VAS scale after one week the subject had felt no

further symptoms of pain after the injection and at one month follow up remained pain free.

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Study QS Conclusions

Hong and Kim

(2013) 1/3

Local steroid injections with anaesthetic reduced symptoms of pain in a singular case study of a female with Iliotibial band friction syndrome

Pain reduced from 7-8/10 on the VAS to 0/10 at the one week follow up and remained 0/10 at a one month follow up

3.5 Outcome Measures – Safety and Risk

Gunter and Schwellnus (2004) reported that none of the 18 subjects reported any side effects

or adverse reactions as a result of either the placebo or the active injection.

However, the ITB can be viewed as an extended tendon of the tensor fascia latae and local

corticosteroid injections are a common treatment for tendinopathies (Fredberg 1997, Paavola

et al. 2002). Research shows that there can be a considerable reduction in tensile strength after

corticosteroid treatment (Haraldsson et al. 2007) and it has been suggested that intratendinous

injections of corticosteroids may impair the healing process of injured tendons and have a

degenerative effect on the tissue (Wiggin et al. 1995, Balasubramniam & Prathap 1972). There

have been several case reports of rupture after intratendinous corticosteroid administration in

both the upper and lower extremities (Ford & DeBender 1979, Halpern, Horowitz & Nagel 1977,

Kleinman & Gross 1998, Nehrer et al. 1997).

This risk is also present in the ITB following corticosteroid injections. Pandit et al. (2014)

presented a case study of a 27-year-old subject with ITB friction syndrome in his left knee.

Along with other modalities the authors reported the subject received a total of three

corticosteroid injections of 40mg triamcinolone acetonide, 4cc 0f 1% lidocaine and 4cc of 0.5%

Marcaine, injected superficially to the lateral femoral condyle of the affected knee, with

approximately 2 months between each injection. The subject was participating in military work

training and subsequently upon running ruptured the insertional aspect of his ITB. The authors

theorized that the rupture occurred as a result of potential weakening of the ITB fibres because

of the repeated corticosteroid injections.

It should be noted however that it is not possible to ascertain the extent these ruptures may

have been caused by the steroid injections and what extent was caused by the underlying

tendinopathy (Haraldsson et al. 2007).

3.6 Economic analysis

This review found no studies that investigated the economic benefits/costs associated with

steroid injections of the ITB as an interventional pain management technique.

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4. Recommendations

Grade of

Recommendation:

• The evidence suggests that local infiltration with corticosteroids decreased pain during running more so than placebo after 14 days (Level C Recommendation based on 1 x HQ RCT and 1 x AQ case series).

• The evidence suggests that the risk of complications associated with steroid injections into the ITB are rare and may be associated with repeated injections. (Level D Recommendation based on 1 x case study).

• Evidence is lacking on the economic value of using steroid injections to the ITB as an interventional pain management technique.

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5. References

Allen, WC & Cope, R 1995, “Coxa Saltans: the snapping hip revisited”, Journal of the American

Academy or Orthopaedic Surgeons, vol. 3, no. 5, pp. 303-308.

Balasubramaniam, P & Prathap, K 1972, “The effect of injection of hydrocortisone into rabbit

calcaneal tendons”, The Journal of Bone and Joint Surgery, vol. 54, no. 4, pp. 729-734.

Birnbaum, K, Siebert, CH, Pandorf, T, Schopphoff, E, Prescher, A & Niethard, FU 2004,

“Anatomical and biomechanical investigations of the iliotibial tract”, Surgical Radiological

Anatomy, vol. 26, no. 6, pp. 433-436.

Di Rosa, M, Calignano, A, Carnuccio, R, Ialenti, A & Sautebin, L 1986, 'Multiple control of

inflammation by glucocorticoids', Inflammation Research, vol. 17, no. 3, pp. 284-289.

Ellis, R, Hing, W & Reid D 2007, “Iliotibial band friction syndrome: A systematic review”,

Manual Therapy, vol. 12, no. 3, pp. 200–208.

Fredberg, U 1997 “Local corticosteroid injection in sport: review of literature and guidelines

for treatment”, Scandinavian Journal of Medicines and Science in Sports, vol. 7, no. 3, pp.

131-139.

Fredericson, M & Wolf, C 2005, “Iliotibial band syndrome in runners: innovations in

treatment”, Sports Medicine, vol. 35, no.5, pp. 451-459.

Ford, LT & DeBender, J 1979, “Tendon rupture after local steroid injection”, Southern Medical

Journal, vol. 72, no. 7, pp. 827-830.

Gunter, P & Schwellnus, MP 2004, “Local corticosteroid injection in iliotibial band friction

syndrome in runners: a randomised controlled trial”, British Journal of Sports Medicine,

vol. 38, no. 3, pp. 269-272.

Haraldsson, BT, Langberg, H, DeGroot, J & Kjaer, M 2007, “Corticosteroids reduce the tensile

strength of isolated collagen fascicles”, The American Journal of Sports Medicine, vol. 34,

no. 12, pp. 1992-1997.

Halpern, AA, Horowitz, BG & Nagel, DA 1977, “Tendon rupture associated with corticosteroid

therapy”, Western Journal of Medicine, vol. 127, no. 5, pp. 378-382.

Hong, JH & Kim, JS 2013, “Diagnosis of Iliotibial Band Friction Syndrome and Ultrasound

Guided Steroid Injection”, The Korean Journal of Pain, vol. 26, no. 4, pp. 387-391.

Khaund, R & Flynn, S, 2005, “Iliotibial band syndrome: a common source of knee pain”,

American Family Physician, vol. 71, no. 8, pp. 1545-1550.

Kleinman, M & Gross, AE 1998, “Achilles tendon rupture following steroid injection: report of

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“Clinical and sonographic evaluation of the risks of rupture in the Achielles Tendon”,

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6. Appendices Appendix 1: Sign Checklists Used in this Review

SIGN Critical Appraisal Tool for Controlled trials

S I G N

Methodology Checklist 2: Controlled Trials

Study identification (Include author, title, year of publication, journal title, pages)

Guideline topic: Key Question No: Reviewer:

Before completing this checklist, consider:

1. Is the paper a randomised controlled trial or a controlled clinical trial? If in doubt, check the study design algorithm available from SIGN and make sure you have the correct checklist. If it is a controlled clinical trial questions 1.2, 1.3, and 1.4 are not relevant, and the study cannot be rated higher than 1+

2. Is the paper relevant to key question? Analyse using PICO (Patient or Population Intervention Comparison Outcome). IF NO REJECT (give reason below). IF YES complete the checklist.

Reason for rejection: 1. Paper not relevant to key question 2. Other reason (please specify):

SECTION 1: INTERNAL VALIDITY

In a well conducted RCT study… Does this study do it?

1.1 The study addresses an appropriate and clearly focused question.

Yes

Can’t say

No

1.2 The assignment of subjects to treatment groups is randomised. Yes

Can’t say

No

1.3 An adequate concealment method is used.

Yes

Can’t say

No

1.4 The design keeps subjects and investigators ‘blind’ about treatment allocation.

Yes

Can’t say

No

1.5 The treatment and control groups are similar at the start of the trial.

Yes

Can’t say □

No

1.6 The only difference between groups is the treatment under investigation.

Yes

Can’t say

No

1.7 All relevant outcomes are measured in a standard, valid and reliable way.

Yes

Can’t say

No

1.8 What percentage of the individuals or clusters recruited into each treatment arm of the study dropped out before the study was completed?

1.9 All the subjects are analysed in the groups to which they were randomly allocated (often referred to as intention to treat analysis).

Yes

Can’t say

No

Does not apply

1.10 Where the study is carried out at more than one site, results are comparable for all sites.

Yes

Can’t say

No

Does not apply

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SECTION 2: OVERALL ASSESSMENT OF THE STUDY

2.1 How well was the study done to minimise bias? Code as follows:

High quality (++)

Acceptable (+)

Low quality (-)

Unacceptable – reject 0

2.2 Taking into account clinical considerations, your evaluation of the methodology used, and the statistical power of the study, are you certain that the overall effect is due to the study intervention?

2.3 Are the results of this study directly applicable to the patient group targeted by this guideline?

2.4 Notes. Summarise the authors’ conclusions. Add any comments on your own assessment of the study, and the extent to which it answers your question and mention any areas of uncertainty raised above.

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Case Series Scoring System

Case Series Information

1. Was the study conducted prospectively?

• Were the key outcomes measured before and after the intervention, using clear criteria

defined a priori? ?/1

2. Was the method of selection of cases identified and appropriate?

• Were patients selected consecutively or in an unbiased manner?

• Was there evidence that the characteristics of the included cases were not significantly

different from those of the treated population?

?/1

3. Was the duration and completeness of follow-up reported and was it adequate?

• Are the number and characteristics of losses to follow-up presented? (Losses to follow-

up >20% are unacceptable, particularly if unaccounted for.)

• Are losses to follow-up managed by performing sensitivity analyses and/or including

them in the final analysis?

?/0.5

?/0.5

Conclusion Total ? /3

Source: Young et al (1999). Lung volume surgery (LVRS) for chronic obstructive pulmonary disease

(COPD) with underlying severe emphysema. A West Midlands Development and Evaluation

Committee Report, University of Birmingham, p51-53.

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Appendix 2: Quality scores for studies used in this review

Randomised controlled trials

Reference (author, year) Questions

Study Year 1.1 1.2 1.3 1.4 1.5 1.6 1.7 1.8 1.9 1.10 2.1 2.2 2.3

Gunter and Schwellnus

2004 Y Y CS CS Y Y Y 0% Y NA HQ(++) Y Y

2.4 Local corticosteroid infiltration effectively decreases pain during running in the first two weeks of treatment in patients with recent onset ITBFS.

Case Series/Case studies

Reference (author, year) Questions

Study Year Study Design

Was the study conducted

prospectively?

Was the method of selection of cases identified and

appropriate?

Was the duration and completeness of follow-up

reported and was it adequate?

Total

Noble 1980 Series 1 0 0.5 1.5

Hong and Kim 2013 Study 1 0.5 0 1.5

Pandit et al 2014 study 0 0 0 0