Foot orthoses for patellofemoral pain in adults

Foot orthoses for patellofemoral pain in adults (Review)

Hossain M, Alexander P, Burls A, Jobanputra P

This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library2011, Issue 1

http://www.thecochranelibrary.com

Foot orthoses for patellofemoral pain in adults (Review)

Copyright © 2011 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

http://www.thecochranelibrary.com

T A B L E O F C O N T E N T S

1HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Figure 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Figure 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Figure 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Figure 4. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Figure 5. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

14DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

15AUTHORS’ CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

15ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

16REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

18CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

25DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Analysis 1.1. Comparison 1 Orthoses versus insole, Outcome 1 Knee pain: numbers with ’global improvement’. . . 27

Analysis 1.2. Comparison 1 Orthoses versus insole, Outcome 2 Worst knee pain during preceding week (VAS: 0 to 100

mm: worst pain). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Analysis 1.3. Comparison 1 Orthoses versus insole, Outcome 3 Functional index questionnaire (0 to 16: no disability). 28

Analysis 1.4. Comparison 1 Orthoses versus insole, Outcome 4 Knee function: anterior knee pain (0 to 100: no

disability). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Analysis 1.5. Comparison 1 Orthoses versus insole, Outcome 5 Concurrent analgesic use. . . . . . . . . . . 29

Analysis 1.6. Comparison 1 Orthoses versus insole, Outcome 6 Adverse effects. . . . . . . . . . . . . . 29

Analysis 2.1. Comparison 2 Orthoses plus physiotherapy versus physiotherapy alone, Outcome 1 Knee pain: numbers with

’global improvement’. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Analysis 2.2. Comparison 2 Orthoses plus physiotherapy versus physiotherapy alone, Outcome 2 Worst knee pain during

preceding week (VAS: 0 to 100 mm: worst pain). . . . . . . . . . . . . . . . . . . . . . 30

Analysis 2.3. Comparison 2 Orthoses plus physiotherapy versus physiotherapy alone, Outcome 3 SF36 pain scale (change

scores at 8 weeks: positive scores = pain reduction). . . . . . . . . . . . . . . . . . . . . . 31

Analysis 2.4. Comparison 2 Orthoses plus physiotherapy versus physiotherapy alone, Outcome 4 Functional index

questionnaire (0 to 16: no disability). . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Analysis 2.5. Comparison 2 Orthoses plus physiotherapy versus physiotherapy alone, Outcome 5 Knee function: anterior

knee pain (0 to 100: no disability). . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Analysis 2.6. Comparison 2 Orthoses plus physiotherapy versus physiotherapy alone, Outcome 6 SF36 physical function

(change scores at 8 weeks: positive scores = decrease in function). . . . . . . . . . . . . . . . . 32

Analysis 2.7. Comparison 2 Orthoses plus physiotherapy versus physiotherapy alone, Outcome 7 Concurrent use of

analgesics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

Analysis 3.1. Comparison 3 Orthoses versus physiotherapy, Outcome 1 Knee pain: numbers with ’global improvement’. 33

Analysis 3.2. Comparison 3 Orthoses versus physiotherapy, Outcome 2 Worst knee pain during preceding week (VAS: 0 to

100 mm: worst pain). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

Analysis 3.3. Comparison 3 Orthoses versus physiotherapy, Outcome 3 SF36 pain scale (change scores at 8 weeks: positive

scores = pain reduction). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Analysis 3.4. Comparison 3 Orthoses versus physiotherapy, Outcome 4 Functional index questionnaire (0 to 16: no

disability). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Analysis 3.5. Comparison 3 Orthoses versus physiotherapy, Outcome 5 Knee function: anterior knee pain (0 to 100: no

disability). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

Analysis 3.6. Comparison 3 Orthoses versus physiotherapy, Outcome 6 SF36 physical function (change scores at 8 weeks:

positive scores = decrease in function). . . . . . . . . . . . . . . . . . . . . . . . . . 36

iFoot orthoses for patellofemoral pain in adults (Review)


Analysis 3.7. Comparison 3 Orthoses versus physiotherapy, Outcome 7 Concurrent analgesic use. . . . . . . . 37

37APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

40HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

40CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

40DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

40SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

41DIFFERENCES BETWEEN PROTOCOL AND REVIEW . . . . . . . . . . . . . . . . . . . . .

iiFoot orthoses for patellofemoral pain in adults (Review)


[Intervention Review]

Foot orthoses for patellofemoral pain in adults

Munier Hossain1 , Paul Alexander2, Amanda Burls3, Paresh Jobanputra4

1Department of Orthopaedics, North West Wales NHS Trust, Bangor, UK. 2Transfusion Transmitted Injuries Section (TTAE), Blood

Safety Surveillance, Public Health Agency of Canada (PHAC), Ottawa, Canada. 3Department of Primary Health Care, University of

Oxford, Oxford, UK. 4Department of Rheumatology, University Hospitals Birmingham NHS Foundation Trust, Selly Oak, UK

Contact address: Munier Hossain, Department of Orthopaedics, North West Wales NHS Trust, Ysbyty Gwynedd Hospital, Bangor,

Wales, LL57 2PW, UK. [email protected].

Editorial group: Cochrane Bone, Joint and Muscle Trauma Group.

Publication status and date: New, published in Issue 1, 2011.

Review content assessed as up-to-date: 22 June 2010.

Citation: Hossain M, Alexander P, Burls A, Jobanputra P. Foot orthoses for patellofemoral pain in adults. Cochrane Database ofSystematic Reviews 2011, Issue 1. Art. No.: CD008402. DOI: 10.1002/14651858.CD008402.pub2.


A B S T R A C T

Background

Foot orthoses, which are specially moulded devices fitted into footwear, are one of the treatment options for patellofemoral or anterior

knee pain.

Objectives

To assess the effects of foot orthoses for managing patellofemoral pain in adults.

Search strategy

We searched the Cochrane Bone, Joint and Muscle Trauma Group’s Specialised Register (March 2010), the Cochrane Central Register

of Controlled Trials (The Cochrane Library 2010, Issue 1), MEDLINE (1950 to March 2010), EMBASE (1980 to 2010 Week 11),

CINAHL (1937 to March 2010), trial registers, reference lists and grey literature. No language restriction was applied.

Selection criteria

We included randomised or quasi-randomised clinical studies that compared foot orthoses with flat insoles or another physical therapy

intervention. The primary outcomes were knee pain and knee function.

Data collection and analysis

Two authors independently selected eligible trials, assessed methodological quality and performed data extraction. We calculated risk

ratios and 95% confidence intervals for dichotomous variables, and mean differences with 95% confidence intervals for continuous

variables. We pooled data using the fixed-effect model.

Main results

Two trials with a total of 210 participants were included. Both trials were at some risk of performance bias. One trial had four intervention

groups and the other had three. One trial found that foot orthoses when compared with flat insoles (control group) had better results

at six weeks in knee pain (participants with global improvement: risk ratio 1.48, 95% confidence interval 1.11 to 1.99), but not at one

year follow-up. Participants in the orthoses group reported significantly more minor adverse effects (e.g. rubbing, blistering) compared

with the flat insole group (risk ratio 1.87, 95% confidence intervaI 1.21 to 2.91). Both trials in their comparisons of orthoses plus

physiotherapy versus physiotherapy alone found no statistically significant differences between the two intervention groups in knee pain

1Foot orthoses for patellofemoral pain in adults (Review)


mailto:[email protected]

or function. Results for knee pain outcomes did not show significant differences between foot orthoses versus physiotherapy. Although

participants in the physiotherapy group had consistently better results for the functional index questionnaire, the clinical relevance of

these results is uncertain.

Authors’ conclusions

While not robust, the available evidence does not reveal any clear advantage of foot orthoses over simple insoles or physiotherapy for

patellofemoral pain. While foot orthoses may help relieve knee pain over the short term, the benefit may be marginal. Patients treated

with orthoses are more likely to complain of mild adverse effects and discomfort.

P L A I N L A N G U A G E S U M M A R Y

Moulded foot insoles for adults with pain around the knee cap

Pain around the knee cap is a common problem. The pain may be brought on or made worse by day to day or sporting/exercise

activities. Pain around the knee cap can have many different causes, such as the way the knee cap glides over the bones or because of

knee overuse. Several different treatment options are available. Foot orthoses are specially moulded devices fitted into footwear. They

are believed to be helpful because they might help improve the alignment of the leg bones.

The aim of this review is to evaluate the effects of foot orthoses on knee pain and knee usage in adults with pain over the front of the

knee. We aimed to compare foot orthoses against no treatment or flat insoles, or other treatments such as physiotherapy.

We included two studies with a total of 210 participants in this review. Both trials were at some risk of bias because not enough care

had been taken to ensure that groups received the same treatment other than the interventions being tested. One trial found some

benefits from using foot orthoses over simple insoles at six weeks but not at one year. Participants wearing orthoses were, however, more

likely to report minor adverse effects (e.g. rubbing, blistering) and discomfort compared with those wearing insoles. There were no

important differences in knee pain and function in people given foot orthoses as well as physiotherapy when compared with people given

physiotherapy only. Results for knee pain and function did not show important differences between foot orthoses versus physiotherapy.

On the basis of the available evidence we do not recommend foot orthoses for adults with pain around the knee cap.

B A C K G R O U N D

Description of the condition

Patellofemoral joint (PFJ) pain, or anterior knee pain, is a com-

mon musculoskeletal condition which frequently leads to medical

consultation and causes significant morbidity (Collins 2008). The

incidence of PFJ pain varies according to the activity level. The

true incidence in the general population is not known but 26%

of young adults presenting at a sports injury clinic over a two-

year period were found to suffer from PFJ pain (Brosseau 2001).

People usually present with pain over the front of the knee. The

pain is provoked by activities such as climbing or descending stairs,

squatting, sitting for prolonged periods and running. The aetiol-

ogy of PFJ pain is not well understood but patellar maltracking or

overuse are believed to be contributing factors. Anterior knee pain

may arise from a variety of pathologies including patellofemoral

arthritis, patellofemoral instability, and tendinopathy. The term

’PFJ pain’ refers specifically to a clinical presentation where there

are none of the signs associated with these pathologies or of acute

knee injury.

The PFJ is a complex joint with a complex movement pattern.

There is some evidence to support the notion that the genesis of

anterior knee pain lies in structural and biomechanical abnormal-

ities. It has been proposed that PFJ pain may develop because

of abnormally directed loads on the knee that exceed the normal

physiologic tissue thresholds (Arendt 2005). Anomalous loading

of the joint may occur due to abnormalities of bony alignment,

joint geometry, soft tissue constraints, neuromuscular control or

functional demands.

Description of the intervention



There is no consensus about what is the best management of this

common clinical condition. Non-surgical treatments are often the

first mode of management for most people with PFJ pain. A wide

range of treatments are used. These include foot orthoses, patel-

lar taping, knee supports, physiotherapy, analgesics, non-steroidal

anti-inflammatory drugs, and surgery. Foot orthoses are specially

moulded devices fitted into footwear. In contrast, normal insoles

are generally flat. Foot orthoses can be off-the-shelf or customised

to individual foot shapes. A plain insole costs much less than off-

the-shelf or customised foot orthoses.

How the intervention might work

Malalignment of the lower limb, resulting in compensatory malpo-

sitioning of the foot is thought to contribute to PFJ pain (Heintjes

2003). It has been suggested that moulded foot orthoses might

help relieve PFJ pain by correcting the foot positioning during

gait or altering lower limb mechanics (Bates 1979; Collins 2008;

Cornwall 1995; Johnston 2004). Others have suggested that foot

orthoses might act by absorbing shock, preventing excessive prona-

tion and abnormal foot motion, as well as by enhancing balance

and proprioceptive performance (Sahar 2009). However, it is un-

clear whether these actions translate to actual clinical improve-

ment. Although there is some evidence that foot orthoses may re-

duce rearfoot movement and affect knee kinematics during certain

phases of gait, the effects on knee symptoms are not clear (Eng

1994). Others have contended that orthoses act as a space filler,

allowing full plantar contact and acting by reducing muscle activ-

ity and energy expenditure (Vicenzino 2008a).

Why it is important to do this review

Cochrane reviews addressing the efficacy of therapeutic ultrasound

(Brosseau 2001), exercise therapy (Heintjes 2003) and pharma-

cotherapy (Heintjes 2004) for the treatment of PFJ pain have been

completed. These reviews show that evidence for the effective-

ness of these interventions is limited and conflicting. A previous

Cochrane review, now withdrawn from The Cochrane Library, ex-

amined the benefits of knee orthoses for PFJ pain and concluded

that the evidence was limited and weak (D’hondt 2002). D’hondt

2002 did not analyse the effectiveness of foot orthoses. Neverthe-

less foot orthoses seem to offer a logical and widely available treat-

ment option for PFJ pain. Therefore a synthesis of the evidence

for the use of foot orthoses and to identify gaps in the research

evidence was indicated.

O B J E C T I V E S

To assess the effects of foot orthoses for patellofemoral joint pain in

adults. More specifically, we planned to evaluate the effectiveness

of foot orthoses compared with placebo, analgesia, no treatment,

or other orthoses (i.e. knee) for PFJ pain.

M E T H O D S

Criteria for considering studies for this review

Types of studies

We included randomised or quasi-randomised (method of allo-

cating trial participants to a treatment which is not strictly ran-

dom; e.g. by date of birth, hospital record number, alternation)

controlled studies.

Types of participants

We included studies of skeletally mature adults (aged 18 years or

over). We excluded trials of adolescents because anterior knee

pain in adolescents is often attributed to abnormalities of skele-

tal growth (e.g. Osgood Schlatter’s disease or Sinding-Larsen syn-

drome). We only included mixed population trials of adults and

adolescents if we could obtain separate data for the adult partici-

pants or where the proportion of adolescents was clearly low (un-

der 10%) and balanced between the two groups. Expert clinical

judgement alone was deemed to be adequate for the diagnosis of

PFJ pain; thus, radiological examination of the knee was not es-

sential.

Types of interventions

For inclusion, studies had to have at least one intervention arm

where foot orthoses were compared with no treatment, placebo,

analgesia or another orthotic device. Examples of orthoses are off-

the-shelf orthoses or custom-made foot orthoses. We extended the

scope of the review to include comparisons of foot orthoses plus

another physical therapy intervention versus the same physical

therapy intervention on its own; and comparisons of foot orthoses

versus another physical therapy intervention.

Types of outcome measures

Primary outcomes

• Knee pain as quantified by a visual analogue scale or any

other validated method, preferably at one year or more follow-up.

• Knee function (any validated and commonly used knee

function score, e.g. WOMAC score, IKSS score), preferably at

one year or more follow-up



Secondary outcomes

• Patient satisfaction assessed using a Likert scale, visual

analogue scale (VAS) or any other validated score.

• Patient reported quality of life score: e.g. SF 36 or EQ5D or

any other validated score.

• Use of analgesics and/or non-steroidal anti-inflammatory

drugs.

• Adverse effects including foot pain, discomfort, or difficulty

in walking and any other important adverse effect reported in

the trials.

Search methods for identification of studies

Electronic searches

We searched the Cochrane Bone, Joint and Muscle Trauma Group

Specialised Register (March 2010), the Cochrane Central Register

of Controlled Trials (The Cochrane Library 2010, Issue 1), MED-

LINE (1950 to March Week 2 2010), EMBASE (1980 to 2010

Week 11), CINAHL - the Cumulative Index to Nursing and Al-

lied Health Literature (1937 to March 2010), the Turning Re-

search into Practice (TRIP) database (to 29/03/10), and PEDro -

the Physiotherapy Evidence Database (to 29/03/10).

In MEDLINE, the subject-specific search (lines 1 to 18) was com-

bined with the Cochrane Highly Sensitive Search Strategy for iden-

tifying randomised trials in MEDLINE: sensitivity-maximizing

version (Lefebvre 2009), and in EMBASE with the Scottish In-

tercollegiate Guidelines Network (SIGN) trial search strategy (seeAppendix 1 for all strategies).

We also searched the WHO International Clinical Trials Registry

Platform and Current Controlled Trials for ongoing trials.

We did not exclude studies on the basis of language or publication

status.

Searching other resources

We checked reference lists of articles and also searched for unpub-

lished studies via contact with firms producing orthotic devices.

We also contacted authors and experts to identify further stud-

ies. We searched for conference proceedings via British Library’s

Zetoc table of contents database of conference proceedings. We

also searched the ProQuest database for theses and the Opensigle

database for unpublished studies (last search on 29/03/10).

Data collection and analysis

Selection of studies

Two authors (MH and PA) independently screened search results

and selected studies for possible inclusion, based on titles and

abstracts. A final decision on inclusion was made from the full text.

Disagreement was resolved by a third author (PJ). We contacted

authors for additional information where necessary.

Data extraction and management

Two authors (MH and PA) independently extracted the data using

a data extraction form. The data extraction form was piloted on

the first trial and any necessary changes made. A third author

(PJ) resolved disagreements. We contacted authors for additional

information and data.

Assessment of risk of bias in included studies

Two authors (MH and PA) independently assessed the risk of bias

of included studies using The Cochrane Collaboration’s ’Risk of

bias’ tool (Higgins 2009). The domains of this tool include: ade-

quate sequence generation, allocation concealment, blinding, in-

complete outcome data, selective reporting, and other potential

sources of bias such as that arising from major imbalances in base-

line characteristics and important differences in care programmes

other than the interventions under test. Any disagreement in as-

sessment was resolved by a third author (PJ). Assessors were not

blinded to author or institution. We contacted trial authors for

clarification when there was uncertainly about trial methodology.

The results of the assessment are displayed in the risk of bias table

and figures, and summarised in the text.

Measures of treatment effect

For dichotomous outcomes we calculated risk ratios and 95%

confidence intervals (95% CI). We used the mean difference (and

95% CI) as the effect measure for continuous outcomes. We would

have used the standardised mean difference (and 95% CI) where

data were pooled from studies reporting comparable, but different,

continuous outcome measures.

Unit of analysis issues

We were alert to potential unit of analysis issues such as where

there is disparity between the unit of randomisation and analysis

for individuals with bilateral involvement. This did not arise in

the current review and we also did not include any study with a

cross-over design.

Dealing with missing data

Where possible, we attempted to perform intention-to-treat analy-

ses that included all people randomised to the intervention groups.

Where we could not obtain missing data from the authors, we

used the denominators reported in the study. We did not assume



http://www.tripdatabase.com/index.html

http://www.pedro.org.au/

http://www.sign.ac.uk/methodology/filters.html#random

http://apps.who.int/trialsearch/Default.aspx





http://controlled-trials.com



http://zetoc.mimas.ac.uk/

http://www.proquest.com

http://www.opensigle.inist.fr

values where missing standard deviations could not be obtained

from trial authors or derived from confidence interval data.

Assessment of heterogeneity

We did not have enough studies to explore heterogeneity. If this

changes in a future update, we plan to assess studies for hetero-

geneity based on a combination of visual inspection of the forest

plots, the chi² test and the I² statistic; and also to assess the clinical

significance of any statistical heterogeneity.

Assessment of reporting biases

We currently do not have enough data to explore publication bias

with funnel plots. However, we were successful in our attempts to

locate unpublished and ongoing studies.

Data synthesis

Only limited pooling was possible. As stated in the protocol, we

used a fixed-effect model to pool data as there was no statistical

heterogeneity. We stipulated that meta-analysis would only be per-

formed if included studies are sufficiently homogenous to allow

for a meaningful summary estimate. Additionally, we stated that

where there is a moderate degree of statistical heterogeneity, we

would check the results using a random-effects model. We stipu-

lated that we would calculate pooled risk ratios and 95% CIs for

dichotomous data, and pooled mean differences (or standardised

mean differences) and 95% CI for continuous data.

Subgroup analysis and investigation of heterogeneity

There were insufficient data available to carry out our planned

subgroup analyses based on gender, activity levels (professional

athlete or military recruits versus recreational athletes or others),

type of orthoses (custom-made versus off-the-shelf orthoses).

Sensitivity analysis

There were insufficient data to perform our planned sensitivity

analyses. We had intended to look at the effects of including trials

at high risk of bias, such as from lack of allocation concealment or

blinding of assessors, or trials reported only in conference abstracts,

by removing these studies from the analyses. We also planned to

perform sensitivity analyses to explore the effects of missing data.

R E S U L T S

Description of studies

See: Characteristics of included studies; Characteristics of excluded

studies; Characteristics of ongoing studies.

See the Characteristics of included studies, Characteristics of

excluded studies and Characteristics of ongoing studies .

Results of the search

We found seven relevant trials. Two trials were included (Collins

2008a; Wiener-Ogilvie 2004); four were excluded (reasons given

below) and one unpublished trial is listed as ongoing (KP Trial).

A study protocol (Vicenzino 2008a) and a duplicate publication

(Collins 2008b) were available for Collins 2008a. Results for

Wiener-Ogilvie 2004 were available also in a research dissertation

(Wiener-Ogilvie 2001).

The complete search yielded 391 references. Figure 1 shows the

flow chart of search strategy results. We excluded 382 references

from preliminary screening of the titles and abstracts. Among

these, 150 were duplicated citations, 161 not relevant, seven did

not include adults, 19 only studied knee arthritis, 12 studies did

not involve foot orthoses, five were case series, and 28 were review

articles. This left seven potentially relevant studies, as described

above.



Figure 1. Flow chart of search strategy results

Included studies

Two randomised controlled trials were included in this review

(Collins 2008a; Wiener-Ogilvie 2004). Figure 2 and Figure 3 show

the participant flow for each trial.



Figure 2. Participant flow Collins 2008a



Figure 3. Participant flow Wiener-Ogilvie 2004

Design of studies

Both included trials were single centre randomised clinical trials.

Collins 2008a was conducted in Australia and Wiener-Ogilvie

2004 in the UK. Neither trial had an untreated control group.

Participants of Collins 2008a were allocated to one of four groups:

foot orthoses; insole; physiotherapy; and foot orthoses plus phys-

iotherapy. Participants of Wiener-Ogilvie 2004 were allocated to

one of three groups: exercise therapy; foot orthoses; and foot or-

thoses plus exercise therapy.

Participants

A total of 210 participants were included in the included trials.

Follow-up data were available for 198 participants: one person died

and seven were lost to follow-up in Collins 2008a; and four did

not complete the trial in Wiener-Ogilvie 2004. Knee symptoms

were mostly chronic: the median duration of knee pain in Collins

2008a was 28 months (interquartile range: 12 to 84 months).

Demographic characteristics



The age range in Collins 2008a was 18 to 40 years (mean 29.3

years). Wiener-Ogilvie 2004 did not give an age range; however,

the mean ages for the three groups were 38.7 years (orthoses

group), 51.0 years (exercise group), and 61.8 years (combined

group). There were 79 male and 100 female participants in Collins

2008a and nine male and 22 female participants in Wiener-Ogilvie

2004.

Clinical characteristics

There were important differences within and between the recruited

cohorts. Collins 2008a included adults recruited from the local

community by advertisements in various media. Wiener-Ogilvie

2004 recruited people of any age with non-traumatic antero-me-

dial knee pain and excessive foot pronation referred by their Gen-

eral Practitioner to the local physiotherapy department. Both trials

had detailed inclusion and exclusion criteria (see Characteristics of

included studies).

Notably, Collins 2008a did not assess foot pronation. Neither

study required prior radiological examination before inclusion.

Interventions

Study grouping according to the interventions under test were:

• Comparison 1: orthoses versus insole (Collins 2008a).

• Comparison 2: orthoses plus physiotherapy versus

physiotherapy alone (Collins 2008a; Wiener-Ogilvie 2004).

• Comparison 3: orthoses versus physiotherapy (Collins

2008a; Wiener-Ogilvie 2004)

Description of insoles and orthoses

Collins 2008a used flat insoles without any wedge arch support

or heel cupping. The authors intended that flat insoles should act

as a control group, that would, at least partially, act as a placebo.

Unmolded flat insoles will not correct lower limb malalignment

and therefore any effects could be due to a placebo effect. However,

it was made of the same material as the orthoses and Collins

2008a also treated insoles with a degree of heat moulding. Both

Collins 2008a and Wiener-Ogilvie 2004 used orthoses of the same

material (ethylenevinyl acetate). These are prefabricated off-the-

shelf orthoses, customisable with heat moulding, wedges or heel

raises. Those receiving foot orthoses had their orthoses moulded

and, if necessary, had sequential trial fitting.

Description of physiotherapy

The ’physiotherapy’ intervention differed between the two trials.

The regimen in Collins 2008a included patellar mobilisation and

taping, progressive vasti (muscles over the anterior aspect of the

thigh) retraining exercises, hamstring and anterior hip stretches,

hip external rotator retraining and a home exercise programme.

Participants were encouraged to “continue exercise and activities

that did not provoke their pain”. Wiener-Ogilvie 2004 prescribed

quadriceps and hamstring stretching and strengthening exercise as

well as hip adductor contraction and dynamic side stepping. A key

difference between the two trials is that Collins 2008a employed

patellar mobilisation and taping.

Outcomes

Collins 2008a reported a number of primary outcome measures.

Sample size calculation was based on a clinically meaningful

change of 15 mm on a 100 mm VAS for pain. The published

protocol of this study refers to a few secondary outcome measures,

none of which were reported in the paper. The senior author con-

firmed that they had collected secondary outcome measures. It is

not clear why these were not reported. Collins 2008a followed up

and assessed participants at six, 12 and 52 weeks. Wiener-Ogilvie

2004 followed up participants at four and eight weeks only.

The outcomes reported by the two included trials are as follows:

Primary outcomes

• Knee pain: knee pain was evaluated in both the studies

using a number of outcome measures:

◦ Visual Analogue Scale (VAS): Collins 2008a reported

usual and worst knee pain over the preceding week on VAS at 6,

12 and 52 weeks (100 mm scale where 100 mm = worst pain).

Wiener-Ogilvie 2004 reported usual knee pain for the preceding

week on a VAS at four and eight weeks (100 mm scale,100 mm =

worst pain).

◦ Global improvement scale: Collins 2008a reported

global improvement on a five point Likert Scale (marked

improvement to marked worsening). The authors categorised

and reported the global improvement scale to those reporting

moderate or marked improvement or not, and reported the

results as relative risk reductions and numbers needed to treat.

They also reported global improvement scale on a VAS (20 cm

scale: -100 mm = much worse, 0 mm = same, 100 mm =

completely better). Wiener-Ogilvie 2004 also reported knee pain

using a global outcome score on a five point Likert scale.

◦ Knee pain scale (KPS): Wiener-Ogilvie 2004 reported

the transfer and ambulation intensity scales of this outcome

measure. The KPS consists of four sub-scales: transfer frequency

scale, ambulation frequency scale, transfer intensity scale,

ambulation intensity scale. This scale was developed for use in

patients with knee osteoarthritis (Rejeski 1995). Each scale

consists of three items; each question is answered on a six point

Likert scale. The scale is scored from 1 to 6 (1 = no pain; 6 =

maximum pain).

◦ Short-Form 36 (SF-36) pain scale: this was reported

by Wiener-Ogilvie 2004. The SF-36 pain scale contains two

questions, one with five and the other with six scoring options.



The sum of scores is converted to a range of 0 to 100 (100 = least

pain).

• Knee function:

◦ Functional index questionnaire (FIQ): this was

reported by Collins 2008a. The FIQ is a patient reported eight

item questionnaire. Each question is answered on a four point

Likert scale. The scale is scored from 0 to 16 points (16 = no

disability) (Chesworth 1989).

◦ Kujala anterior knee pain scale: this was reported by

Collins 2008a. The Kujala anterior knee pain scale measures

disability due to anterior knee pain. It consists of 13 patient

reported questions (total: 0 to 100 points, 100 points = no

disability) (Kujala 1993).

Secondary outcomes

• Patient satisfaction: Wiener-Ogilvie 2004 collected limited

information related to patient satisfaction with the orthoses;

these results were reported in a dissertation (Wiener-Ogilvie

2001).

• Quality of life: Wiener-Ogilvie 2004 reported data from

the SF-36 physical function scale. The SF36 physical function

scale contains 10 questions with three scoring options for each

question. Scores from raw data are converted to a scale of 0 to

100 (100 = best health).

• Concurrent analgesic use: data are available from both

Collins 2008a and Wiener-Ogilvie 2004.

• Adverse effects: only Collins 2008a reported adverse effects

of the interventions.

While Collins 2008a did not report compliance with the various

interventions, they reported the numbers of participants in each

group who did not receive the intervention according to protocol

because they attended fewer than six sessions. Collins 2008a also

detailed participant reported use of co-interventions for PFJ dur-

ing the trial. Participants of Wiener-Ogilvie 2004 kept a diary of

their compliance with exercises, and also completed a question-

naire at the end of the trial regarding their compliance. However,

some data were missing and the authors found that there was dis-

crepancy between the diary entries and patients’ recollection of

their compliance.

Excluded studies

The Characteristics of excluded studies details the reasons for ex-

cluding four trials. In summary, one study included adolescent

females only (Eng 1993); one study did not trial foot orthoses

(Miller 1997); one trial did not provide sufficient information to

determine if the small subgroup of participants had patellofemoral

pain (Trotter 2008); and one unpublished trial did not report knee

pain despite purporting to do so at trial registration (Wies 2009).

Risk of bias in included studies

Figure 4 and Figure 5 show the review authors’ judgement of risk

of bias in the included studies.



Figure 4. Methodological quality summary: review authors’ judgements about each methodological quality

item for each included study.

Figure 5. Methodological quality graph: review authors’ judgements about each methodological quality

item presented as percentages across all included studies.



Allocation

Both of the included studies satisfied criteria for adequate ran-

domisation as well as allocation concealment. In Collins 2008a

the randomisation sequence was drawn up and kept off site. A

research assistant contacted the randomisation centre at recruit-

ment. Wiener-Ogilvie 2004 used sealed dark brown envelopes

containing the group numbers. The envelopes were shuffled and

the patient chose an envelope (Wiener-Ogilvie 2001).

Blinding

Patients, unsurprisingly, were not blinded in either trial. Collins

2008a blinded both the outcome assessor and the data analyst.

Wiener-Ogilvie 2004 did not blind outcome assessors. The possi-

bility remains that the side-effects reported in Collins 2008a were

influenced by lack of participant blinding.

Incomplete outcome data

Collins 2008a was considered at low risk of bias. Although eight

of the 179 randomised participants dropped out (one died, seven

could not be contacted), the results of the remaining 171 partic-

ipants were analysed on an intention-to-treat basis. This was ir-

respective of the fact that 22 participants received fewer sessions

of their allocated intervention physiotherapy than intended, and

two from the insole group crossed over to using foot orthoses at

12 weeks. Patient data were available for 27 out of 31 participants

in Wiener-Ogilvie 2004. Two male and two female participants

dropped out of the trial early: one participant was hospitalised,

another had an accidental knee injury, one discontinued the trial

for personal reasons and the last participant requested a different

mode of treatment unrelated to the study interventions after three

weeks of treatment (Wiener-Ogilvie 2001). The risk of bias from

incomplete data was considered unclear for this trial.

Selective reporting

The study protocol of Collins 2008a was published prior to the

trial (Vicenzino 2008a). The authors reported all primary out-

comes described in the protocol. This was also the only trial to

have reported any adverse effects of foot orthoses. However, the

protocol refers to a number of secondary outcomes, none of which

were reported in the published study. A protocol was not available

for Wiener-Ogilvie 2004.

Other potential sources of bias

Similarity of baseline characteristics

Baseline characteristics of the participants allocated to different

treatment groups differed in the two trials. Patients allocated to

physiotherapy had more females compared with the other inter-

vention groups in Collins 2008a; the duration of knee pain also

differed between the groups. However, Collins 2008a noted that

“including baseline data as covariates did not significantly influ-

ence outcomes”. In Wiener-Ogilvie 2004, there were more male

and relatively young participants with higher mean height in the

orthoses group. Conversely, more participants in the exercise group

took anti-inflammatory drugs or pain killers as well as having the

lowest mean duration of symptoms; and the combined group had

the highest mean age and weight and the longest mean duration

of symptoms.

Equal treatment of different groups

Care programmes, apart from the trial interventions, were not

identical in both trials. This resulted in a high risk of performance

bias in the included trials. Patients who received foot orthoses had a

greater degree of contact and care from health professionals during

the fitting of their foot orthoses, whereas the flat insole group only

received minimal care in Collins 2008a. Collins 2008a did not

report either the contact time or the number of sessions required

for fitting of insoles or orthoses. Whereas the participants in the

foot orthoses group were prescribed the home exercise regimen for

twice daily performance for both legs, home exercise for the flat

insole group was not reinforced. The number of sessions allocated

for contact with care givers also differed between the different

intervention groups in Wiener-Ogilvie 2004. The trial authors did

not report any attempts to control for such differential levels of

care in these two studies.

Summary of overall risk of bias

Risk of bias was judged as low in terms of sequence generation

and allocation concealment. Due to the nature of the interven-

tions it was not possible to blind the participants to the interven-

tion. However, Collins 2008a achieved some objectivity by blind-

ing the assessors. There was some imbalance in baseline charac-

teristics in both Collins 2008a and Wiener-Ogilvie 2004. Par-

ticipant contact with health professionals and attention to detail

for ensuring comparable care other than the trial interventions

differed in the included studies (Collins 2008a; Wiener-Ogilvie



2004). Performance bias was such that outcomes could have been

influenced significantly. Incomplete reporting was identified for

Collins 2008a, which did not report some secondary outcomes

and for Wiener-Ogilvie 2004, which did not describe adverse ef-

fects.

Effects of interventions

While long term follow-up data are more appropriate for partici-

pants whose chronic knee pain lasted from between nine and 96

months in the included cohort, we present also short term data

given these were available from both trials. For Collins 2008a,

we present data for six weeks (at the end of treatment) and for

52 weeks. Wiener-Ogilvie 2004 limited their follow-up to eight

weeks only. Where data are pooled from both the studies, these

usually apply to six weeks follow-up in Collins 2008a and eight

weeks follow-up in Wiener-Ogilvie 2004.

Collins 2008a reported knee pain using a number of outcome

measures. We present global improvement scale and worst knee

pain using VAS for this trial in the following.

Only Wiener-Ogilvie 2004 provided data on patient satisfaction.

Fifteen out of the 18 participants prescribed orthoses found them

comfortable or very comfortable. Only seven could fit the orthoses

into “almost any shoes”, while the rest found it difficult to fit or-

thoses or could only fit them into one or two pairs of shoes. A

majority (14) got used to the orthoses within a few days but five

had to buy new shoes to accommodate the prescribed orthoses.

Most participants found most of the nine types of prescribed ex-

ercises easy or moderately easy to perform; although seven rated

one prescribed exercise as difficult.

Comparison 1: orthoses versus insole

Only Collins 2008a performed this comparison.

Primary outcomes

Knee pain

Although early results for global improvement scale (categorical)

favoured the orthoses group (Risk Ratio (RR) 1.48, 95% CI 1.11

to 1.99), the difference between the two groups was not statistically

significant at 52 weeks (RR 1.15, 95% CI 0.92 to 1.44) (seeAnalysis 1.1). A similar finding applied to the results for worst pain

VAS (see Analysis 1.2). However, the differences between the two

groups were neither statistically nor clinically significant at either

follow-up time (6 weeks: MD -8.20, 95% CI -17.67 to 1.27; 52

weeks: MD 1.50, 95% CI -8.57 to 11.57).

Knee function

There were no statistically significant differences between the two

groups in knee function, assessed using the Functional Index Ques-

tionnaire, at either six or 52 weeks follow-up (6 weeks: MD 0.70,

95% CI -0.30 to 1.70; 52 weeks: MD -0.40, 95% CI -1.50 to

0.70; see Analysis 1.3). The results of the anterior knee pain scale

were marginally better in the orthoses group at six weeks (MD

4.30, 95% CI 0.34 to 8.26) but not at 52 weeks (MD -1.40, 95%

CI -5.50 to 2.70) (see Analysis 1.4).

Secondary outcomes

Neither patient satisfaction nor quality of life were reported. There

was no statistically significant difference in concurrent analgesic

use between the two groups (RR 0.89, 95% CI 0.45 to 1.78; seeAnalysis 1.5). Patients treated with orthoses reported significantly

more adverse effects (rubbing, blistering, discomfort, pain in toes)

compared with the insole group (RR 1.87, 95% CI 1.21 to 2.91,

see Analysis 1.6). All adverse effects were rated as mild.

Comparison 2: orthoses plus physiotherapy versus

physiotherapy alone

Primary outcomes

Knee pain

Neither the pooled short-term results for the global improvement

scale (RR 1.00, 95% CI 0.86 to 1.17) nor the long-term results

for Collins 2008a alone favoured one group over the other (RR

1.01 95% CI 0.82 to1.23) (see Analysis 2.1). Collins 2008a found

no significant differences between the two groups in worst pain

VAS at either six weeks (MD -3.70, 95% CI -12.99 to 5.59) or

at one year follow-up (MD -3.40, 95% CI -13.52 to 6.72) (seeAnalysis 2.2). Wiener-Ogilvie 2004 found no statistically signifi-

cant difference between the two groups in the change scores over

eight weeks for the SF-36 pain scale (MD 9.60, 95% CI -8.99 to

28.19, see Analysis 2.3). Notably, the mean score for the combined

intervention group did not change over the eight week period.

Knee function

There was no statistically significant differences between the two

groups in knee function, assessed using the Functional Index Ques-

tionnaire, at either six or 52 weeks follow-up (6 weeks: MD 0.40

95% CI -0.59 to 1.39; 52 weeks: MD -0.40, 95% CI -1.51 to

0.71; see Analysis 2.4). There were no significant differences be-

tween the two groups in the anterior knee pain scale results at six

weeks (MD 0.20, 95% CI -3.72 to 4.12) or at 52 weeks (MD

3.60, 95% CI -0.52 to 7.72); the clinical significance of the small



difference potentially favouring the combined intervention group

is doubtful (see Analysis 2.5).

Secondary outcomes

Wiener-Ogilvie 2004 found no statistically significant difference

between the two groups in the change scores over eight weeks

for the SF-36 physical function scale (MD -4.50, 95% CI -17.36

to 8.36, see Analysis 2.6). There was no statistically significant

difference in concurrent analgesic use between the two groups

(RR 0.56, 95% CI 0.28 to 1.13; see Analysis 2.7). Data were not

available for total adverse effects for the physiotherapy only group

in Collins 2008a.

Comparison 3: orthoses versus physiotherapy

Primary outcomes

Knee pain

There were no significant differences between the two groups in

the global improvement scale results at both follow-up times (6

weeks: RR 0.99, 95% CI 0.80 to 1.21; 52 weeks: RR 1.04, 95%

CI 0.86 to 1.27; see Analysis 3.1). Similar findings applied for

worst pain VAS results measured in Collins 2008a (6 weeks: MD

7.60, 95% CI -1.77 to 16.97; 52 weeks: MD 5.40, 95% CI -

4.57 to 15.37; see Analysis 3.2). Wiener-Ogilvie 2004 found no

statistically significant difference between the two groups in the

change scores over eight weeks for the SF-36 pain scale (MD 13.30,

95% CI -9.19 to 35.79; see Analysis 3.3).

Knee function

The physiotherapy group of Collins 2008a had statistically sig-

nificant better knee function, assessed using the Functional Index

Questionnaire, compared with the orthoses group at both follow-

up points (6 weeks: MD -1.10, 95% CI -2.10 to -0.10; 52 weeks:

MD -1.20, 95% CI -2.29 to -0.11; see Analysis 3.4). There were

no significant differences between the two groups in the anterior

knee pain scale results at six weeks (MD -3.70, 95% CI -7.64

to 0.24) or at 52 weeks (MD -2.40, 95% CI -6.48 to 1.68); the

clinical significance of the small differences potentially favouring

the physiotherapy group is doubtful (see Analysis 3.5).

Secondary outcomes

Wiener-Ogilvie 2004 found no significant difference between the

two groups in the change scores over eight weeks for the SF-36

physical function scale (MD 0.24, 95% CI -0.68 to 1.17, seeAnalysis 3.6). There was no significant difference between the two

groups in concurrent analgesic use (RR 0.81, 95% CI 0.44 to

1.49; see Analysis 3.7). Data were not available for total adverse

effects for the physiotherapy only group of Collins 2008a.

D I S C U S S I O N

Summary of main results

Two randomised trials with a total of 210 participants were in-

cluded. There are three comparisons. Only limited pooling for

short-term outcomes was possible.

Orthoses versus insoles

Based on the available evidence from one trial, foot orthoses com-

pared with insoles (control intervention) improved knee pain at six

weeks follow-up coinciding with the end of the initial treatment

period, but this benefit was not maintained at one year follow-up,

nor was it evident for any of the other outcome measures. There

is evidence that patients using orthoses had significantly more ad-

verse effects, of a minor nature, than those using insoles.

Orthoses plus physiotherapy versus physiotherapy

alone

Providing orthoses in addition to physiotherapy did not lead to

improved knee pain or function outcome compared with physio-

therapy alone. Analgesic requirements were also similar between

the two groups. There were insufficient data to conclude on pa-

tient satisfaction or adverse effects.

Orthoses versus physiotherapy

There were no significant differences between foot orthoses versus

physiotherapy in knee pain outcomes or in measures of knee func-

tion except for the results for the functional index questionnaire

which favoured the physiotherapy group. The clinical relevance

of these latter findings is unclear, especially in the context of the

reports of poor reliability and validity for the functional index

questionnaire. Given these, Crossley 2004 recommended that this

outcome measure should not be used for patellofemoral pain.

Overall completeness and applicability ofevidence

Neither of the included trials included an untreated control group,

although Collins 2008a used flat insoles as a ’placebo’. Thus it is

unclear whether the effects seen represent a spontaneous improve-

ment or benefits arising from paying care and attention to the pa-

tient’s needs rather than specific aspects of the intervention based



on beliefs about pathophysiology. It has been shown that there

can be spontaneous improvement in patellofemoral pain. Up to

22% patients with anterior knee pain diagnosed in adolescence

were completely pain free at a mean follow-up of 16 years (Nimon

1998). Unequal treatment of different intervention groups by pro-

viding different levels of attention and care from care-givers might

have given rise to performance bias in the trials but also impedes

the attribution of trial findings to the stated interventions. There

were insufficient data to perform subgroup analyses and to deter-

mine if the effect of the intervention differed according to differ-

ent patient characteristics such as age, gender, activity levels and

duration of knee pain. Vicenzino 2008b, in a post-hoc analysis of

the orthoses group of Collins 2008a, identified age, height, pain

severity and mid foot morphometry as variables possibly affecting

treatment success. These observations may warrant investigation

in future studies. Currently though there is no evidence to deter-

mine whether foot orthoses might be useful for a particular sub-

group of people with PFJ pain. Notably, the association between

rearfoot eversion and PFJ pain remains controversial and the use-

fulness of orthoses, based on its suggested mechanism of action of

restoration of knee biomechanics, in a subgroup of patients with

rearfoot eversion or patellar malalignment might merit further in-

vestigation.

Quality of the evidence

Wiener-Ogilvie 2004 was a small trial with a short and inadequate

follow-up. Although they did not find any significant difference

between the intervention groups the possibility of type II error

(false negative) cannot be ruled out. Collins 2008a presented data

from a longer follow-up and also performed a priori sample size

calculation. In both studies allocation was concealed and random.

This, however, did not prevent imbalances in baseline characteris-

tics in both trials; those in Wiener-Ogilvie 2004 put this trial at a

high risk of bias. Neither of the trials were exempt from the risk of

performance bias and, we believe, this could also have influenced

the findings of both trials.

Potential biases in the review process

The review was conducted in accordance with a previously pub-

lished protocol. We searched extensively for both published and

unpublished studies to avoid publication bias. We also contacted

study authors and acknowledged experts for more information on

studies and were able to include unpublished information in our

review. We did not locate any studies in the non-English literature.

It is possible that such studies might have been missed despite our

efforts. The stages of study search, selection, data collection and

analyses were all performed by more than one person to minimise

bias.

Agreements and disagreements with otherstudies or reviews

Although we have found no other review specifically investigating

the efficacy of foot orthoses in managing PFJ pain, a previous

review investigating the efficacy of various physical interventions

including foot orthoses found limited evidence to support the use

of physical interventions in general in the management of PFJ

pain (Crossley 2001). Our findings are similar to those of Bizzini

2003 where authors found significant methodological limitations

in the available RCTs on management of PFJ pain that cast doubts

about the validity of the study results.

A U T H O R S ’ C O N C L U S I O N S

Implications for practice

Despite the high incidence of patellofemoral joint (PFJ) pain and

widespread use of foot orthoses, very few randomised trials have

investigated the efficacy of this intervention. Though limited, the

available evidence does not reveal any clear advantage of foot or-

thoses over simple insoles or physiotherapy for PFJ pain. While

foot orthoses may help relieve knee pain over the short term, the

benefit is likely to be marginal and patients treated with orthoses

are more likely to have minor adverse effects such as rubbing, blis-

tering and discomfort.

Implications for research

Further research, via randomised trials with adequate sample size,

is needed to establish whether there is a role for foot orthoses in

the treatment of PFJ pain. We suggest that future research should

directed at comparisons of foot orthoses versus no treatment, sup-

portive care alone and a placebo group in a randomised trial over a

one year period. Such trials should include also participants with

PFJ pain who have excessive foot pronation or patellar malalign-

ment, and subgroup analysis should be performed to determine

if the results differ for these participants. Prior specification of

subgroups should help to assess the clinical relevance of patellar

maltracking and rear foot motion, and any other pathophysiolog-

ical aspects currently believed to be important for PFJ pain. Apart

from using validated measures of knee pain and knee function, the

trial should also report on physical and mental well being of the

participants, compliance, adverse effects, and costs. Any such trials

should follow established standards for good practice and careful

consideration must be given to ’placebo’ effects and performance

bias.

A C K N O W L E D G E M E N T S



We thank Mrs Lesley Gillespie, Dr Helen Handoll, Dr Michael

Callaghan, Dr Vicki Livingstone and Dr Janet Wale for valuable

comments during the development of the review. We would also

like to thank Mrs Lindsey Elstub, Dr Joanne Elliott and Ms Amy

Kavanagh at the Cochrane Bone, Joint and Muscle Trauma Group.

The authors also wish to thank the following researchers for pro-

viding additional information of their respective studies: Prof

Christopher Nester, Dr Joshua Wies, Dr Janice Eng, Ms Leslie

Tortter and Prof Bill Vicenzino. We are especially grateful to Ms

Sharon Wiener-Ogilvie for entrusting us with her dissertation. We

also gratefully acknowledge the help of Ms Kim Andrews (Post-

graduate Education Officer of The Society Of Chiropodists And

Podiatrists) and Dr Karl Landorf (Senior Lecturer and Research

Coordinator of La Trobe University, Australia) for their help in

locating relevant studies.

R E F E R E N C E S

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Wiener-Ogilvie 2001

Wiener-Ogilvie S. A randomised trial of exercise therapy and foot

orthoses as treatment for knee pain in primary care. Glasgow, UK:

University of Strathclyde, 2001.∗ Indicates the major publication for the study



C H A R A C T E R I S T I C S O F S T U D I E S

Characteristics of included studies [ordered by study ID]

Collins 2008a

Methods Method of randomisation: by generation of randomisation sequence by an independent

off-site body

Assessor blinding: yes

Intention-to-treat analysis: yes

Participants Location: single centre trial within a community setting in Brisbane, Australia.

Number of participants (N): 179

Inclusion criteria:

• age 18 to 40 years

• insidious onset of anterior knee or retropatellar pain of greater than six weeks’

duration

• pain provoked by at least two of: prolonged sitting or kneeling, squatting,

running, hopping, or stair walking

• tenderness on palpation of the patella, or pain with step down or double leg squat

• worst pain over the previous week of at least 30 mm on a 100 mm VAS.

Exclusion criteria:

• concomitant injury or pain from the hip, lumbar spine, or other knee structures

• previous knee surgery; patellofemoral instability; knee joint effusion

• any foot condition that precluded use of foot orthoses

• allergy to strapping tape; use of physiotherapy or foot orthoses within the

previous year or use of anti-inflammatory drugs.

Age: range 18 to 40 years (mean 29.3 years)

Gender (male:female): 79:100

Assigned: 46 (group 1), 44 (group 2), 45 (group 3), 44 (group 4)

Analysed: 45 (group 1), 41 (group 2), 42 (group 3), 43 (group 4)

Interventions Four intervention groups: Group 1: off the shelf foot orthoses, Group 2: flat insoles,

Group 3: physiotherapy, Group 4: foot orthoses plus physiotherapy

Timing of intervention: 6 appointments, each lasting 20 to 60 minutes, over 6 weeks

with the physiotherapists. Self-management for the rest of the study period thereafter

(52 weeks).

Description of interventions:

Group 1: received prefabricated, commercially available orthoses fitted to their shoes

and customised, if necessary, to optimise comfort through heat moulding and by adding

wedge or heel raises.

Group 2: flat insoles, manufactured from the same material with identical covering fabric,

of uniform thickness, with no inbuilt arch or wedging, underwent heat moulding.

Group 3: physiotherapy consisted of patellar mobilisation, patellar taping, a progressive

programme of vasti muscle retraining exercises with electromyographic biofeedback,

hamstring and anterior hip stretches, hip external rotator retraining, and a home exercise

programme.

Group 4: participants received both orthoses and physiotherapy as described above and

had an extra appointment with the physiotherapist if necessary.

The participants were advised to continue exercise and activities that did not provoke their



Collins 2008a (Continued)

pain. Both the foot orthoses group and the flat insole group were prescribed additional

home exercise programme. Whereas this was prescribed to be performed bilaterally twice

daily for the orthoses group, the exercise programme was not reinforced for the flat insole

group.

Outcomes Length of follow-up: all the groups were followed up and assessed at 6, 12 and 52 weeks.

Primary outcomes:

Knee pain: global improvement on a 5 point Likert Scale and Visual Analogue Scale

(VAS) (20 cm scale: -10 cm = much worse, 10 cm = completely better), usual and worst

pain over the preceding week on VAS (10 cm scale: 0 to 10; 10 cm = worst pain),

Knee function: the anterior knee pain scale (0 to 100 points, 100 point = no disability),

the functional index questionnaire (0 to 16 points, 16 = no disability)

Secondary outcomes:

Adverse effects and co-interventions used were recorded in diaries, reported to the re-

search assistant, or detailed in an “exit questionnaire”.

The published protocol of the paper refers to a number of other secondary outcome

measures, none of which were reported in the published paper.

Notes Interventions given by 17 qualified and trained physiotherapists. Off the shelf orthoses

used, but customised if patients complained of discomfort. Study performed and reported

a priori sample size calculation.

Risk of bias

Item Authors’ judgement Description

Adequate sequence generation? Yes The authors used “a random number gen-

erator in blocks of eight with no stratifica-

tion”

Allocation concealment? Yes Randomisation sequence drawn up and

kept off site, contact with randomisation

centre via a research assistant .

Blinding?

All outcomes

Unclear “the assessor responsible for outcome mea-

surement and data analysis remained blind

to group allocation”. Participants were not

blinded.

Incomplete outcome data addressed?

All outcomes

Yes Initial randomisation = 179. Drop out =

8 (1 died, 7 lost to follow-up). 20 partici-

pants received fewer sessions of physiother-

apy than intended, two participants from

insole group crossed over to foot orthoses

group at 12 weeks. All participants were

analysed on an intention-to-treat basis



Collins 2008a (Continued)

Free of selective reporting? No All primary outcomes were reported. How-

ever, various secondary outcomes men-

tioned in the protocol were not reported in

the published study.

Similarity of baseline characteristics? Yes The median duration of knee pain was con-

siderably greater in patients treated with

foot orthoses (42 months) compared with

the foot orthoses plus physiotherapy group

(24 months). Groups were otherwise com-

parable.The authors, however, state that in-

cluding the baseline data as covariates did

not significantly influence outcomes.

Equal treatment of different groups? No The insole group had less contact with

the physiotherapist compared with the or-

thoses group. Home exercise programme

was not reinforced in the flat insole group

compared with the orthoses group.

Wiener-Ogilvie 2004

Methods Method of randomisation: sealed dark brown envelopes containing numbers (1, 2 or 3:

1 = exercise therapy, 2 = foot orthoses, 3 = combination therapy) were randomly shuffled

and the patient chose to open the envelope (Wiener-Ogilvie 2001).

Assessor blinding: no

Intention-to-treat analysis: no

Participants Location: single centre trial in Wishaw, Lanarkshire, UK

Number of participants (N): 31

Inclusion criteria:

• patients of all ages with antero-medial knee pain referred by their GP for

physiotherapy, associated with excessive foot pronation

Exclusion criteria:

• systemic rheumatoid conditions

• knee pain associated with previous direct trauma to the knee

• back injuries including neurological damage, sciatica and disc problems

• residual knee pain in patients where hip pain was the main complaint

• previous knee surgery

• intra-articular knee injections in the last six months

• pregnant patients.

Age: mean ages (and standard deviations) of different groups were as follows: orthoses

38.7 (17.2) years, exercise 51.0 (22.5) years, combined group 61.8 (10.3) years

Gender (male:female): 9:22 (2 males and 2 females dropped out early)

Assigned: 11 (group 1), 10 (group 2), 10 (group 3)

Analysed: 9 (group 1), 9 (group 2), 9 (group 3)



Wiener-Ogilvie 2004 (Continued)

Interventions Three intervention groups: Group 1: functional foot orthoses (orthoses group), Group

2: exercise therapy for the knee (exercise group), Group 3: a combination of exercise

therapy and foot orthoses (combined group)

Timing of intervention: Patients received supervised treatment over a 4 week period.

Patients receiving the knee exercise regimen (groups 2 and 3) were seen twice a week for

two weeks and then once a week for a further two weeks by a physiotherapist (6 sessions

in total). Patients receiving foot orthoses (groups 1 and 3) were assessed by the podiatrist

once a week for 3 weeks to check for the fitness of the orthoses. Patients were advised to

continue to wear the orthoses and perform exercises on their own accord after 4 weeks.

Description of interventions:

Group 1: Functional foot orthoses. Foot orthoses group were provided with foot orthoses

with a 40° rearfoot post. Rearfoot posts and forefoot posts were adjusted using 20° or

40° additional wedges, if necessary.

Group 2: Exercise therapy for the knee (exercise group). The exercise therapy included

the following exercises:

• Isometric quadriceps contractions in full knee and hip extension.

• Isometric quadriceps contractions with hip slightly flexed and knee in full

extension.

• Isotonic quadriceps contractions without resistance.

• Isotonic quadriceps contractions with resistance.

• Isotonic hamstring contractions.

• Dynamic stepping exercise.

• Hamstrings stretching exercises.

• Isometric hip adductors contractions.

• Dynamic side stepping.

Group 3: A combination of exercise therapy and foot orthoses (combined group)

Outcomes Length of follow-up: 8 weeks

Primary outcomes:

• knee pain: global improvement scale (5 point Likert scale),

• knee pain: VAS (10 cm scale: 0 least pain, 10 worst pain)

• knee pain: transfer and ambulation intensity scales of the knee pain scale (each

scale consists of a patient reported three items questionnaire, each question answered

on a six point Likert scale. The scale is scored from 1 to 6 (1 = no pain, 6 = maximum

pain)

• knee pain: SF-36 pain scale. The scale contains 2 questions, one with five and the

other with six scoring options. The sum of scoring is converted to a range of 0 to 100

(100 = least pain).

• physical function: SF-36 physical function scale. The scale contains 10 questions

with three scoring options for each question. The scoring from the raw data is

converted to a scale of 0 to 100 (100 = best health).

Secondary outcomes:

The authors did not report any adverse effects but did report concurrent analgesic use.

Notes One podiatrist and two physiotherapists assessed all patients and were given a two-hour

training session to familiarise themselves with the standardised assessment and treatment

protocol.




Risk of bias

Item Authors’ judgement Description

Adequate sequence generation? Yes “randomisation carried out...containing

numbers 1, 2, 3”. Each sealed envelope

contained a number. Each number repre-

sented an allocated group. Envelopes were

randomly mixed up.

Allocation concealment? Yes “sealed dark brown envelope, patients

chose the envelope randomly”

Blinding?

All outcomes

No Care givers and participants not blinded.

Incomplete outcome data addressed?

All outcomes

Unclear 27/31 completed the trial. Two male and

two female participants dropped out of

the trial early: one participant was hospi-

talised, another had an accidental knee in-

jury, one discontinued the trial for personal

reasons and the last participant requested

a different mode of treatment unrelated to

the study interventions after three weeks of

treatment (Wiener-Ogilvie 2001).

Free of selective reporting? Unclear Reported all the listed outcomes. How-

ever, the authors did not report adverse ef-

fects of orthoses. The authors did collect

limited information on participant satis-

faction of using orthoses, which is avail-

able in a dissertation by the first author

(Wiener-Ogilvie 2001).

Similarity of baseline characteristics? No There were a number of demographic dif-

ferences between the treatment groups.

Patients treated with orthoses were more

likely to be male, younger, and taller. Those

treated with exercise alone were more likely

to be taking anti-inflammatory drugs or

pain killers and had symptoms for the least

time. The combined group had the high-

est mean age and weight and the longest

mean duration of symptoms. These differ-

ences may have biased the findings of the

trial.




Equal treatment of different groups? No Different groups received different levels of

attention from the physiotherapist with the

orthoses group receiving the least number

of sessions.

VAS = visual analogue scale

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion

Eng 1993 The authors compared the efficacy of orthoses versus flat insoles. Both groups also received additional physiotherapy.

Knee pain as assessed with a VAS over eight weeks. But all participants were adolescent females with non-traumatic

bilateral retropatellar knee pain beginning insidiously and with excessive foot pronation and as such the trial did not

meet inclusion criteria.

Miller 1997 This study was a randomised controlled trial but only examined the efficacy of knee orthoses on patellofemoral pain.

Trotter 2008 This was a randomised controlled trial with a cross-over design. The authors compared the efficacy of foot orthoses

and prefabricated insoles on lower extremity musculoskeletal pain. The trial included five patients with knee pain but

the authors were not able to give any further details of these five patients. It is not clear how many, if any, of these

five participants with knee pain actually had patellofemoral pain.

Wies 2009 Although this randomised controlled trial was stated at trial registration to be looking at the effects of custom semi-

rigid full-foot orthoses “on planta-surface foot pain and anterior knee pain”, the lead investigator confirmed by

personal communication that the study is now completed but that knee pain was not in fact recorded.

VAS = visual analogue scale

Characteristics of ongoing studies [ordered by study ID]

KP Trial

Trial name or title A randomised controlled trial to evaluate the effectiveness of insoles to treat anterior knee (patella femoral)

pain

Methods Randomised, subject-blinded, single-centre trial

Participants 100 male or female participants meeting the following criteria

1. Aged between 18 and 65 years

2. With self-reported anterior knee pain (pain at the front of the knee) with a minimum of 4 weeks duration



KP Trial (Continued)

3. With self-reported anterior knee pain who score at least 40 mm on a 100 mm visual analogue scale (VAS)

for pain

4. With self-reported anterior knee pain in the 2 days prior to recruitment

5. Who agree to wear the insoles provided for at least 4 hours each day and complete diary cards and postal

questionnaire as required

6. Who give written informed consent

Interventions The participants will be randomly allocated to the following two arms:

1. Orthaheel® regular. This is a 3/4 length insole with arch shape. It is inserted into shoes and worn daily

for 12 months

2. Sham control insole. This is a full length 3 mm deep soft flat insole. It is inserted into shoes and worn daily

for 12 months

Outcomes 1. Knee pain

2. Knee function

Starting date 28/03/2008

Contact information Dr Christopher Nester

Director Centre for Rehabilitation & Human Performance Research

Brian Blatchford Building, University of Salford, Salford

United Kingdom, M6 6PU

Notes This study was funded by a commercial foot care firm. The lead investigator has confirmed that the study is

complete but the findings have not yet been reported. There was significant loss to follow-up in this series.



D A T A A N D A N A L Y S E S

Comparison 1. Orthoses versus insole

Outcome or subgroup titleNo. of

studies

No. of

participants Statistical method Effect size

1 Knee pain: numbers with ’global

improvement’

1 Risk Ratio (M-H, Fixed, 95% CI) Totals not selected

1.1 6 weeks (end of treatment) 1 Risk Ratio (M-H, Fixed, 95% CI) Not estimable

1.2 52 weeks 1 Risk Ratio (M-H, Fixed, 95% CI) Not estimable

2 Worst knee pain during

preceding week (VAS: 0 to 100

mm: worst pain)

1 Mean Difference (IV, Fixed, 95% CI) Totals not selected

2.1 6 weeks (end of treatment) 1 Mean Difference (IV, Fixed, 95% CI) Not estimable

2.2 52 weeks 1 Mean Difference (IV, Fixed, 95% CI) Not estimable

3 Functional index questionnaire

(0 to 16: no disability)


3.1 at 6 weeks (end of

treatment)

1 Mean Difference (IV, Fixed, 95% CI) Not estimable


4 Knee function: anterior knee

pain (0 to 100: no disability)




5 Concurrent analgesic use 1 Risk Ratio (M-H, Fixed, 95% CI) Totals not selected

6 Adverse effects 1 Risk Ratio (M-H, Fixed, 95% CI) Totals not selected

Comparison 2. Orthoses plus physiotherapy versus physiotherapy alone


studies

No. of



improvement’

2 Risk Ratio (M-H, Fixed, 95% CI) Subtotals only

1.1 6 or 8 weeks (end of

treatment)

2 101 Risk Ratio (M-H, Fixed, 95% CI) 1.00 [0.86, 1.17]

1.2 52 weeks 1 85 Risk Ratio (M-H, Fixed, 95% CI) 1.01 [0.82, 1.23]



mm: worst pain)




3 SF36 pain scale (change scores at

8 weeks: positive scores = pain

reduction)







4.1 at 6 weeks 1 Mean Difference (IV, Fixed, 95% CI) Not estimable







6 SF36 physical function (change

scores at 8 weeks: positive

scores = decrease in function)


7 Concurrent use of analgesics 2 101 Risk Ratio (M-H, Fixed, 95% CI) 0.56 [0.28, 1.13]

Comparison 3. Orthoses versus physiotherapy


studies

No. of



improvement’

2 Risk Ratio (M-H, Fixed, 95% CI) Subtotals only

1.1 6 or 8 weeks (end of

treatment)

2 105 Risk Ratio (M-H, Fixed, 95% CI) 0.99 [0.80, 1.21]

1.2 52 weeks 1 87 Risk Ratio (M-H, Fixed, 95% CI) 1.04 [0.86, 1.27]



mm: worst pain)



treatment)



3 SF36 pain scale (change scores at

8 weeks: positive scores = pain

reduction)






treatment)








6 SF36 physical function (change

scores at 8 weeks: positive

scores = decrease in function)

1 Std. Mean Difference (IV, Fixed, 95% CI) Totals not selected

7 Concurrent analgesic use 2 101 Risk Ratio (M-H, Fixed, 95% CI) 0.81 [0.44, 1.49]



Analysis 1.1. Comparison 1 Orthoses versus insole, Outcome 1 Knee pain: numbers with ’global

improvement’.

Review: Foot orthoses for patellofemoral pain in adults

Comparison: 1 Orthoses versus insole

Outcome: 1 Knee pain: numbers with ’global improvement’

Study or subgroup Orthoses Insole Risk Ratio Risk Ratio

n/N n/N M-H,Fixed,95% CI M-H,Fixed,95% CI

1 6 weeks (end of treatment)

Collins 2008a 35/41 23/40 1.48 [ 1.11, 1.99 ]

2 52 weeks

Collins 2008a 38/45 30/41 1.15 [ 0.92, 1.44 ]

0.5 0.7 1 1.5 2

Favours insole Favours orthoses

Analysis 1.2. Comparison 1 Orthoses versus insole, Outcome 2 Worst knee pain during preceding week

(VAS: 0 to 100 mm: worst pain).



Outcome: 2 Worst knee pain during preceding week (VAS: 0 to 100 mm: worst pain)

Study or subgroup Orthoses Insole Mean Difference Mean Difference

N Mean(SD) N Mean(SD) IV,Fixed,95% CI IV,Fixed,95% CI


Collins 2008a 41 39.8 (21.7) 40 48 (21.8) -8.20 [ -17.67, 1.27 ]

2 52 weeks

Collins 2008a 45 27.6 (23.7) 41 26.1 (23.9) 1.50 [ -8.57, 11.57 ]

-50 -25 0 25 50

Favours orthoses Favours insole



Analysis 1.3. Comparison 1 Orthoses versus insole, Outcome 3 Functional index questionnaire (0 to 16: no

disability).



Outcome: 3 Functional index questionnaire (0 to 16: no disability)



1 at 6 weeks (end of treatment)

Collins 2008a 41 11.8 (2.3) 40 11.1 (2.3) 0.70 [ -0.30, 1.70 ]

2 52 weeks

Collins 2008a 45 13 (2.6) 41 13.4 (2.6) -0.40 [ -1.50, 0.70 ]

-4 -2 0 2 4


Analysis 1.4. Comparison 1 Orthoses versus insole, Outcome 4 Knee function: anterior knee pain (0 to 100:

no disability).



Outcome: 4 Knee function: anterior knee pain (0 to 100: no disability)




Collins 2008a 41 79.1 (9.1) 40 74.8 (9.1) 4.30 [ 0.34, 8.26 ]

2 52 weeks

Collins 2008a 45 85.5 (9.7) 41 86.9 (9.7) -1.40 [ -5.50, 2.70 ]

-20 -10 0 10 20




Analysis 1.5. Comparison 1 Orthoses versus insole, Outcome 5 Concurrent analgesic use.



Outcome: 5 Concurrent analgesic use



Collins 2008a 11/40 12/39 0.89 [ 0.45, 1.78 ]

0.01 0.1 1 10 100


Analysis 1.6. Comparison 1 Orthoses versus insole, Outcome 6 Adverse effects.



Outcome: 6 Adverse effects



Collins 2008a 31/43 15/39 1.87 [ 1.21, 2.91 ]

0.01 0.1 1 10 100




Analysis 2.1. Comparison 2 Orthoses plus physiotherapy versus physiotherapy alone, Outcome 1 Knee pain:

numbers with ’global improvement’.


Comparison: 2 Orthoses plus physiotherapy versus physiotherapy alone


Study or subgroup Orthoses plus physio Physiotherapy alone Risk Ratio Weight Risk Ratio


1 6 or 8 weeks (end of treatment)

Collins 2008a 38/42 38/41 92.8 % 0.98 [ 0.86, 1.11 ]

Wiener-Ogilvie 2004 4/9 3/9 7.2 % 1.33 [ 0.41, 4.33 ]

Subtotal (95% CI) 51 50 100.0 % 1.00 [ 0.86, 1.17 ]

Total events: 42 (Orthoses plus physio), 41 (Physiotherapy alone)

Heterogeneity: Chi2 = 0.38, df = 1 (P = 0.54); I2 =0.0%

Test for overall effect: Z = 0.03 (P = 0.98)

2 52 weeks

Collins 2008a 35/43 34/42 100.0 % 1.01 [ 0.82, 1.23 ]

Subtotal (95% CI) 43 42 100.0 % 1.01 [ 0.82, 1.23 ]


Heterogeneity: not applicable


0.2 0.5 1 2 5

Favours physio only Favours orthoses + phy

Analysis 2.2. Comparison 2 Orthoses plus physiotherapy versus physiotherapy alone, Outcome 2 Worst

knee pain during preceding week (VAS: 0 to 100 mm: worst pain).




Study or subgroup Orthoses plus physio Physiotherapy alone Mean Difference Mean Difference



Collins 2008a 42 28.5 (21.6) 41 32.2 (21.6) -3.70 [ -12.99, 5.59 ]

2 52 weeks

Collins 2008a 43 18.8 (23.9) 42 22.2 (23.7) -3.40 [ -13.52, 6.72 ]

-20 -10 0 10 20

Favours orthoses + phy Favours physio only



Analysis 2.3. Comparison 2 Orthoses plus physiotherapy versus physiotherapy alone, Outcome 3 SF36 pain

scale (change scores at 8 weeks: positive scores = pain reduction).



Outcome: 3 SF36 pain scale (change scores at 8 weeks: positive scores = pain reduction)



Wiener-Ogilvie 2004 9 0 (13.27) 9 -9.6 (25.17) 9.60 [ -8.99, 28.19 ]

-20 -10 0 10 20


Analysis 2.4. Comparison 2 Orthoses plus physiotherapy versus physiotherapy alone, Outcome 4 Functional

index questionnaire (0 to 16: no disability).






1 at 6 weeks

Collins 2008a 42 13.3 (2.3) 41 12.9 (2.3) 0.40 [ -0.59, 1.39 ]

2 52 weeks

Collins 2008a 43 13.8 (2.6) 42 14.2 (2.6) -0.40 [ -1.51, 0.71 ]

-4 -2 0 2 4

Favours physio only Favours orthoses + physio



Analysis 2.5. Comparison 2 Orthoses plus physiotherapy versus physiotherapy alone, Outcome 5 Knee

function: anterior knee pain (0 to 100: no disability).







Collins 2008a 42 83.6 (9.1) 41 83.4 (9.1) 0.20 [ -3.72, 4.12 ]

2 52 weeks

Collins 2008a 43 91.5 (9.7) 42 87.9 (9.7) 3.60 [ -0.52, 7.72 ]

-20 -10 0 10 20


Analysis 2.6. Comparison 2 Orthoses plus physiotherapy versus physiotherapy alone, Outcome 6 SF36

physical function (change scores at 8 weeks: positive scores = decrease in function).



Outcome: 6 SF36 physical function (change scores at 8 weeks: positive scores = decrease in function)



Wiener-Ogilvie 2004 9 -8.9 (16.78) 9 -4.4 (10.28) -4.50 [ -17.36, 8.36 ]

-20 -10 0 10 20




Analysis 2.7. Comparison 2 Orthoses plus physiotherapy versus physiotherapy alone, Outcome 7

Concurrent use of analgesics.



Outcome: 7 Concurrent use of analgesics

Study or subgroup Orthoses plus physio Physiotherapy alone Risk Ratio Weight Risk Ratio


Collins 2008a 7/40 13/43 75.8 % 0.58 [ 0.26, 1.30 ]

Wiener-Ogilvie 2004 2/9 4/9 24.2 % 0.50 [ 0.12, 2.08 ]

Total (95% CI) 49 52 100.0 % 0.56 [ 0.28, 1.13 ]




0.05 0.2 1 5 20


Analysis 3.1. Comparison 3 Orthoses versus physiotherapy, Outcome 1 Knee pain: numbers with ’global

improvement’.


Comparison: 3 Orthoses versus physiotherapy


Study or subgroup Orthoses Physiotherapy Risk Ratio Weight Risk Ratio


1 6 or 8 weeks (end of treatment)

Collins 2008a 38/45 34/42 92.1 % 1.04 [ 0.86, 1.27 ]

Wiener-Ogilvie 2004 1/9 3/9 7.9 % 0.33 [ 0.04, 2.63 ]

Subtotal (95% CI) 54 51 100.0 % 0.99 [ 0.80, 1.21 ]

Total events: 39 (Orthoses), 37 (Physiotherapy)

Heterogeneity: Chi2 = 1.37, df = 1 (P = 0.24); I2 =27%


2 52 weeks

Collins 2008a 38/45 34/42 100.0 % 1.04 [ 0.86, 1.27 ]

0.05 0.2 1 5 20

Favours physiotherapy Favours orthoses

(Continued . . . )



(. . . Continued)Study or subgroup Orthoses Physiotherapy Risk Ratio Weight Risk Ratio


Subtotal (95% CI) 45 42 100.0 % 1.04 [ 0.86, 1.27 ]


Heterogeneity: not applicable


0.05 0.2 1 5 20


Analysis 3.2. Comparison 3 Orthoses versus physiotherapy, Outcome 2 Worst knee pain during preceding

week (VAS: 0 to 100 mm: worst pain).




Study or subgroup Orthoses Physiotherapy Mean Difference Mean Difference



Collins 2008a 41 39.8 (21.7) 41 32.2 (21.6) 7.60 [ -1.77, 16.97 ]

2 at 52 weeks

Collins 2008a 45 27.6 (23.7) 42 22.2 (23.7) 5.40 [ -4.57, 15.37 ]

-100 -50 0 50 100

Favours orthoses Favours physiotherapy



Analysis 3.3. Comparison 3 Orthoses versus physiotherapy, Outcome 3 SF36 pain scale (change scores at 8

weeks: positive scores = pain reduction).



Outcome: 3 SF36 pain scale (change scores at 8 weeks: positive scores = pain reduction)



Wiener-Ogilvie 2004 9 3.7 (23.48) 9 -9.6 (25.17) 13.30 [ -9.19, 35.79 ]

-20 -10 0 10 20


Analysis 3.4. Comparison 3 Orthoses versus physiotherapy, Outcome 4 Functional index questionnaire (0

to 16: no disability).







Collins 2008a 41 11.8 (2.3) 41 12.9 (2.3) -1.10 [ -2.10, -0.10 ]

2 52 weeks

Collins 2008a 45 13 (2.6) 42 14.2 (2.6) -1.20 [ -2.29, -0.11 ]

-4 -2 0 2 4




Analysis 3.5. Comparison 3 Orthoses versus physiotherapy, Outcome 5 Knee function: anterior knee pain

(0 to 100: no disability).






1 at 6 weeks

Collins 2008a 41 79.7 (9.1) 41 83.4 (9.1) -3.70 [ -7.64, 0.24 ]

2 at 52 weeks

Collins 2008a 45 85.5 (9.7) 42 87.9 (9.7) -2.40 [ -6.48, 1.68 ]

-10 -5 0 5 10


Analysis 3.6. Comparison 3 Orthoses versus physiotherapy, Outcome 6 SF36 physical function (change

scores at 8 weeks: positive scores = decrease in function).



Outcome: 6 SF36 physical function (change scores at 8 weeks: positive scores = decrease in function)

Study or subgroup Orthoses Physiotherapy Std. Mean Difference Std. Mean Difference


Wiener-Ogilvie 2004 9 -1.1 (14.97) 9 -4.4 (10.28) 0.24 [ -0.68, 1.17 ]

-2 -1 0 1 2




Analysis 3.7. Comparison 3 Orthoses versus physiotherapy, Outcome 7 Concurrent analgesic use.



Outcome: 7 Concurrent analgesic use

Study or subgroup Orthoses Physiotherapy Risk Ratio Weight Risk Ratio


Collins 2008a 11/40 13/43 75.8 % 0.91 [ 0.46, 1.79 ]

Wiener-Ogilvie 2004 2/9 4/9 24.2 % 0.50 [ 0.12, 2.08 ]

Total (95% CI) 49 52 100.0 % 0.81 [ 0.44, 1.49 ]




0.01 0.1 1 10 100


A P P E N D I C E S

Appendix 1. Search strategies

Cochrane Central Register of Controlled Trials (Wiley InterScience interface)

#1 MeSH descriptor Patellofemoral Pain Syndrome, this term only

#2 MeSH descriptor Patella, this term only

#3 MeSH descriptor Knee Joint, this term only

#4 MeSH descriptor Knee, this term only

#5 (#2 OR #3 OR #4)

#6 MeSH descriptor Arthralgia, this term only

#7 MeSH descriptor Pain, this term only

#8 (#6 OR #7)

#9 (#5 AND #8)

#10 (anterior knee pain):ti,ab,kw

#11 ((patell* or femoropatel* or femoro-patell* or retropatell*) NEAR/2 (pain or syndrome or dysfunction)):ti,ab,kw

#12 ((lateral compression or lateral facet or lateral pressure or odd facet) NEAR syndrome) :ti,ab,kw

#13 ((chondromalac* or chondropath*) NEAR/2 (knee* or patell* or femoropatell* or femoro-patell* or retropatell*)):ti,ab,kw

#14 MeSH descriptor Chondromalacia Patellae, this term only

#15 (#1 OR #9 OR #10 OR #11 OR #12 OR #13 OR #14)

#16 MeSH descriptor Orthotic Devices, this term only

#17 MeSH descriptor Braces, this term only

#18 (orthos?s or orthotic* or insert):ti,ab,kw

#19 (#16 OR #17 OR #18)

#20 MeSH descriptor Foot, this term only



#21 MeSH descriptor Shoes, this term only

#22 (foot or feet or shoe*):ti,ab,kw

#23 (#20 OR #21 OR #22)

#24 (#19 AND #23)

#25 (#15 AND #24)

MEDLINE (Ovid interface)

1. Patellofemoral Pain Syndrome/

2. Patella/ or Knee Joint/ or Knee/

3. Arthralgia/ or Pain/

4. and/2-3

5. anterior knee pain.tw

6. ((patell$ or femoropatell$ or femoro-patell$ or retropatell$) adj2 (pain or syndrome or dysfunction)).tw.

7. ((lateral compression or lateral facet or lateral pressure or odd facet) adj syndrome).tw.

8. ((chondromalac$ or chondropath$) adj2 (knee$1 or patell$ or femoropatell$ or femoro-patell$ or retropatell$)).tw.

9. Chondromalacia Patellae/

10. or/1,4-9

11. Orthotic Devices/ or Braces/

12. (orthos#s or orthotic$ or insert).tw.

13. or/11-12

14. Foot/ or Shoes/

15. (foot or feet or shoe$).tw.

16. or/14-15

17. and/3,16

18. and/10,17

19. randomized controlled trial.pt.

20. controlled clinical trial.pt.

21. randomized.ab.

22. placebo.ab.

23. randomly.ab.

24. trial.ab.

25. groups.ab.

26. or/19-25

27. exp Animals/ not Humans/

28. 26 not 27

29. and/18,28

EMBASE (Ovid interface)

1. Patellofemoral Pain Syndrome/

2. Patellofemoral Joint/ or Patella/ or Knee/

3. Arthralgia/ or Pain/

4. and/2,3

5. Knee Pain/

6. anterior knee pain.tw.

7. ((patell$ or femoropatell$ or femoro-patell$ or retropatell$) adj2 (pain or syndrome or dysfunction)).tw.

8. ((lateral compression or lateral facet or lateral pressure or odd facet) adj syndrome).tw.

9. ((chondromalac$ or chondropath$) adj2 (knee$1 or patell$ or femoropatell$ or femoro-patell$ or retropatell$)).tw.

10. Patella Chondromalacia/

11. or/1,4-10

12. “Prostheses and Orthoses”/ or Foot orthosis/ or Orthosis/

13. (orthos#s or orthotic$ or insert).tw.



14. or/12-13

15. Foot/ or Shoe/ or Orthopedic Shoe/

16. (foot or feet or shoe$).tw.

17. or/15-16

18. and/14,17

19. and/11,18

20. Clinical trial/

21. Randomized controlled trial/

22. Randomization/

23. Single blind procedure/

24. Double blind procedure/

25. Crossover procedure/

26. Placebo/

27. Randomi?ed controlled trial$.tw.

28. Rct.tw.

29. Random allocation.tw.

30. Randomly allocated.tw.

31. Allocated randomly.tw.

32. (allocated adj2 random).tw.

33. Single blind$.tw.

34. Double blind$.tw.

35. ((treble or triple) adj blind$).tw.

36. Placebo$.tw.

37. Prospective study/

38. or/20-37

39. Case study/

40. Case report.tw.

41. Abstract report/ or letter/

42. or/39-41

43. 38 not 42

44. limit 43 to human

45. and/19,44

Lines 20-43 = Scottish Intercollegiate Guidelines Network search filter for randomised controlled trials

CINAHL Plus (EBSCOhost)

S1 (MH “Patellofemoral Pain Syndrome”)

S2 (MH “Patella”) or (MH “Knee Joint”) or (MH “Knee”)

S3 (MH “Arthralgia”) or (MH “Pain”)

S4 S2 and S3

S5 TX anterior knee pain

S6 TX ( patell* or femoropatell* or retropatell* ) and TX ( pain or syndrome or dysfunction )

S7 TX ( lateral compression or lateral facet or lateral pressure or odd facet ) and TX syndrome

S8 TX ( chondromalac* or chondropath* ) and TX ( knee* or patell* or femoropatell* or femoro-patell* or retropatell* )

S9 (MH “Chondromalacia Patella”)

S10 S1 or S4 or S5 or S6 or S7 or S8 or S9

S11 (MH “Foot Orthoses”) or (MH “Orthoses”) or (MH “Orthoses Design”) or (MH “Orthoses Fitting”)

S12 TX orthos?s or orthotic$*or insert

S13 S11 or S12

S14 (MH “Foot”) or (MH “Shoes”) or (MH “Orthopedic Footwear”)

S15 TX foot or feet or shoe*

S16 S14 or S15

S17 S13 and S16



S18 S10 and S17

S19 (MH “Clinical Trials+”)

S20 (MH “Evaluation Research+”)

S21 (MH “Comparative Studies”)

S22 (MH “Crossover Design”)

S23 PT Clinical trial

S24 S19 or S20 or S21 or S22 or S23

S25 TX ( clinical or controlled or comparative or placebo or prospective or randomised or randomized ) and TX ( trial or study

)

S26 TX random* and TX ( allocat* or allot* or assign* or basis* or divid* or order* )

S27 TX ( singl* or doubl* or trebl* or tripl* ) and TX ( blind* or mask* )

S28 TX crossover* or cross-over or “cross over”

S29 TX ( allocat* or allot* or assign* or divid* ) and TX ( condition* or experiment* or intervention* or treatment* or therap* or

control* or group*

S30 S25 or S26 or S27 or S28 or S29

S31 S24 or S30

S32 S18 and S31

H I S T O R Y

Protocol first published: Issue 3, 2010

Review first published: Issue 1, 2011

C O N T R I B U T I O N S O F A U T H O R S

MH conceived the idea for the review and developed and finalised it with advice from PJ and AB. MH wrote the preliminary draft

which was revised by PA, AB and PJ. MH and PA developed the search strategy with the help of Joanne Elliott (Trials Search Co-

ordinator, Cochrane Bone, Joint and Muscle Trauma Group). MH and PA independently extracted data and judged risk of bias of the

included studies. This was reviewed and adjudicated by PJ. MH analysed and interpreted data which was overseen by PJ and AB. MH

wrote the final draft of the review which was revised by PJ and AB. PJ provided clinical expertise in interpretation and analysis. AB

provided general advice for the review at all stages.

D E C L A R A T I O N S O F I N T E R E S T

None known

S O U R C E S O F S U P P O R T



Internal sources

• Betsy Cadwaladr University Health Board, Bangor, UK.

• University of Oxford, UK.

• University Hospitals of Birmingham, UK.

External sources

• No sources of support supplied

D I F F E R E N C E S B E T W E E N P R O T O C O L A N D R E V I E W

We clarified that foot orthoses did not include flat insoles.

We extended the scope of the review to include comparisons of foot orthoses plus any another physical therapy intervention versus the

same physical therapy intervention on its own; and comparisons of foot orthoses versus any other physical therapy interventions.



Documents

Foot orthoses for patellofemoral pain in adults