11
Orthotic devices for treating patellofemoral pain syndrome (Review) D’hondt NE, Struijs PAA, Kerkhoffs GMMJ, Verheul C, Lysens R, Aufdemkampe G, Van Dijk CN This is a reprint of a Cochrane review, prepared and maintained by The Cochrane Collaboration and published in The Cochrane Library 2002, Issue 2 http://www.thecochranelibrary.com Orthotic devices for treating patellofemoral pain syndrome (Review) Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Orthotic devices for treating patellofemoral pain syndrome

Embed Size (px)

Citation preview

Orthotic devices for treating patellofemoral pain syndrome

(Review)

D’hondt NE, Struijs PAA, Kerkhoffs GMMJ, Verheul C, Lysens R, Aufdemkampe G, Van Dijk

CN

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

2002, Issue 2

http://www.thecochranelibrary.com

Orthotic devices for treating patellofemoral pain syndrome (Review)

Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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

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

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

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

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

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

3RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5AUTHORS’ CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

6REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

9SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

9NOTES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

9INDEX TERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

iOrthotic devices for treating patellofemoral pain syndrome (Review)

Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

[Intervention Review]

Orthotic devices for treating patellofemoral pain syndrome

NE D’hondt, PAA Struijs, GMMJ Kerkhoffs, C Verheul, R Lysens, G Aufdemkampe, Van CN Dijk

Contact address: Mr Norman D’hondt, Physiotherapist, Sports & Orthopaedic Rehabilitation Centre, Van Huis & Van’t Kloosterv,

Physiotherapists, Catharijnesingel 73, Utrecht, 3511 GM, NETHERLANDS. [email protected].

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

Publication status and date: Unchanged, published in Issue 4, 2008.

Review content assessed as up-to-date: .

Citation: D’hondt NE, Struijs PAA, Kerkhoffs GMMJ, Verheul C, Lysens R, Aufdemkampe G, Van Dijk CN. Orthotic devices

for treating patellofemoral pain syndrome. Cochrane Database of Systematic Reviews 2002, Issue 2. Art. No.: CD002267. DOI:

10.1002/14651858.CD002267.

Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

A B S T R A C T

Background

Patellofemoral pain syndrome is a frequently reported condition in active adults. A wide variety of conservative treatment strategies

have been described. As yet, no optimal strategy has been identified. Application of orthotic devices e.g. knee braces, knee straps, forms

of taping of the knee, active training devices, knee sleeves and in-shoe orthotics to support the foot have been advocated to treat this

condition.

Objectives

To assess the effectiveness of foot and knee orthotics for treatment of patellofemoral pain syndrome.

Search strategy

We searched the Cochrane Musculoskeletal Injuries Group specialised register (December 2001), the Cochrane Controlled Trials

register (Issue 2, 2000), MEDLINE (January 1966 to March 2000; EMBASE (January 1988 to March 2000); CINAHL (January

1982 to March 2000) and PEDro (up to March 2000). Relevant orthotic companies were contacted.

Selection criteria

All randomised and quasi-randomised trials comparing the effectiveness of knee or foot orthotics for treatment of patellofemoral pain

syndrome were selected. Trials describing the use of orthotic devices in conjunction with operative treatment were excluded.

Data collection and analysis

Three reviewers independently assessed methodological quality of the identified trials by use of a modified version of the Cochrane

Musculoskeletal Injuries Group assessment tool, consisting 11 items. Two reviewers extracted data without blinding. Trialists were

contacted to obtain missing data.

Main results

Five trials involving 362 participants were included in this review. Five other trials await possible inclusion if further information can be

obtained and one awaits further assessment. Due to clinical heterogeneity, we refrained from statistical pooling and conducted analysis

by grading the strength of scientific evidence. The level of obtained research-based evidence was graded as limited as all trials were of

low methodological quality.

This limited research-based evidence showed the Protonics orthosis at six week follow-up was significantly more effective for decrease in

pain (weighted mean difference (WMD) between groups 3.2; 95% confidence interval (CI) 2.8 to 3.6), functional improvement on the

1Orthotic devices for treating patellofemoral pain syndrome (Review)

Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Kujala score (WMD 45.6; 95% CI 43.4 to 47.7) and change in patellofemoral congruence angle (WMD 17.2; 95% CI 14.1 to 20.3)

when compared to no treatment. A comprehensive programme including tape application was significantly superior to a monitored

exercise programme without tape application for decrease in worst pain (WMD 1.6; 95% CI 0.4 to 2.8) and usual pain (WMD 1.2;

95% CI 0.2 to 2.1), and clinical change and functional improvement questionnaire scores (WMD 10, 95% CI 2.07 to 17.93) at four

weeks follow-up. The trials reported statistically significant differences in patient satisfaction after applied therapy (WMD 3.3; 95%

CI 0.5 to 6.1) in favour of the McConnell regimen compared with the Coumans bandage at six weeks follow-up.

Authors’ conclusions

The evidence from randomised controlled trials is currently too limited to draw definitive conclusions about the use of knee and foot

orthotics for the treatment of patellofemoral pain. Future high quality trials in this field are warranted.

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

Not enough evidence from trials to determine the effect of knee and foot orthotics (tape, braces, straps, sleeves or in-shoe pads) in

easing kneecap pain

Patellofemoral pain syndrome (soreness around the area of the kneecap) is common in active adolescents and adults. It seems to be

made worse after activities involving heavy knee loads such as walking up stairs, running, or cycling. It can be treated either by surgery

or, more commonly, by using orthotics (tape, braces, straps, sleeves or inlay soles). These are usually used alongside some type of exercise

therapy. This review of trials found that there was not enough information on any of these orthotics to be able to say if they relieve

patellofemoral pain syndrome. More research is needed.

B A C K G R O U N D

Patellofemoral pain syndrome (PFPS), is a frequently diagnosed

entity in active adolescents and adults. The Dutch Institute for Re-

search in Health Care (NIVEL) reports that 56,000 new patients

per year contact their general practitioner with patellofemoral

complaints in The Netherlands alone (Van der Velden 1991).

Characteristically, PFPS develops gradually with diffuse peripatel-

lar and retropatellar pain, often accompanied by complaints of

“giving way” and crepitus (Van Linge 1995; Nissen 1998; Powers

1998). The onset of pain seems to be triggered by overuse of the

patellofemoral joint, as symptoms are typically provoked by phys-

ical activity. These can include such activities as walking up and

down stairs, running, cycling or prolonged sitting (theatre sign),

and are likely to be relieved by rest (Powers 1998; Nissen 1998;

Zomerdijk 1998).

There is no consensus in the medical literature concerning defini-

tion, etiology, diagnosis of patellofemoral pain syndrome (Holmes

1998; Wilk 1998) and no clear association is present between

the severity of symptoms and arthroscopic or radiological findings

(Natri 1998; Nissen 1998; Lindberg 1986). Current concepts on

the genesis of patellofemoral pain suggest that it is unlikely that

hyaline articular cartilage damage is a direct source of pain because

it is completely free of free nerve endings. On the contrary, the

patella’s subchondral bone and its surrounding structures (such

as the lateral and medial retinacula, the peripatellar synovium,

the medial plicae, the patellar and quadriceps tendon and the in-

frapatellar fat pad) were found to have these free nerve endings.

This indicates that several structures may participate in the genesis

of patellofemoral pain (Jackson 2001; Dye 2001; Biedert 2001).

Therefore it is difficult to have a clear diagnosis of PFPS as other

conditions associated with these structures, such as infrapatellar

fat pad impingement or insertion tendinopathy of the quadriceps

muscles, may be present.

Patellofemoral mal-alignment is frequently mentioned as an etio-

logic mechanism in the genesis of PFPS (Zomerdijk 1998). Mal-

alignment may lead to a deviant tracking pattern of the patella

with respect to the femoral groove, which could cause an ab-

normal distribution of the joint’s reaction stress on the patella’s

subchondral bone and impingement of surrounding soft tissues

(Badalamente 1989; Grelsamer 1998). Tight anatomical struc-

tures (Puniello 1993; Nissen 1998), an unbalanced m. vastus me-

diales oblique / m. vastus lateralis response-reaction time ratio

(Witvrouw 1996) and deviation of anatomy (Holmes 1998) may

predispose to patellofemoral mal-alignment. Furthermore, deviant

tracking of the patella may also be induced by a dynamically in-

2Orthotic devices for treating patellofemoral pain syndrome (Review)

Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

creased valgus angle (also termed “kneeing-in”). Absence of ade-

quate muscle control and excessive pronation of the foot, result-

ing in an internal rotation of the lower extremity, could provoke

this. In a large two-year follow-up study, it was suggested that the

development of patellofemoral pain in an athletic population is

predisposed by a shortened quadriceps muscle, an altered vastus

mediales obliques muscle reflex response time, a decreased explo-

sive strength, and a hyper-mobile patella (Witvrouw 2000).

Conservative treatment of PFPS is generally preferred to operative

treatment, consisting of releasing the lateral retinaculum or reposi-

tioning the tibial tuberosity (Brody 1998; Shelton 1991; Scunderi

1992). A wide variety of conservative strategies is reported in the

literature, varying from quadriceps strengthening exercises, the use

of non-steroidal anti-inflammatory drugs (NSAIDs), and the ap-

plication of orthotic devices (Arroll 1997, Zomerdijk 1998). In

one systematic review, (Arroll 1997), five clinical trials on non-op-

erative management of PFPS were identified. It was concluded that

insufficient evidence was present to draw definitive conclusions

on the effectiveness of conservative treatment strategies. Another

systematic review, which identified six randomised clinical trials

on conservative treatment, confirmed this conclusion (Zomerdijk

1998).

The use of in-shoe orthotics and knee orthotics, both tending to

influence the patella’s tracking pattern, were previously advocated

for treatment of patellofemoral pain syndrome (Eng 1993; Gerrard

1989; Harrison 1999; Klingman 1997; Powers 1998; Saxena 1998;

Shellock 1994; Shelton 1991), and remain a treatment of choice.

Types of orthotic modalities vary from knee braces, knee straps,

knee sleeves and taping techniques. These are meant to directly

support patellar tracking or re-distribute stress on the articulating

patellar surface and, in-shoe orthotics, to support the medial arch

of the foot. The latter prevents excessive pronation of the foot.

This review has been undertaken to assess the effectiveness of these

knee and foot orthotics in the treatment of PFPS.

O B J E C T I V E S

The objective of this review was to assess the use of foot and knee

orthotics (e.g. brace, sleeve, taping techniques, bandage, straps,

in-shoe orthotics) as a conservative treatment strategy for PFPS in

active adolescents and adults, without limiting for sex, or level of

physical activity.

The specific null hypothesis was:

There are no differences in treatment outcome for PFPS when

managed with or without the use of orthotic devices.

Comparisons included:

a) no treatment versus orthotic devices;

b) one type of orthotics versus other(s);

c) another conservative treatment versus orthotic devices.

R E S U L T S

Due to the clinical heterogeneity of interventions investigated, no

pooling of data from the included studies was undertaken.

McCONNELL REGIMEN VERSUS COUMANS BANDAGE

Wijnen 1996 compared the McConnell regimen to the applica-

tion of a Coumans bandage. This trial involved only 18 subjects.

Three subjects dropped out of the study and were not taken into

account in the statistical analysis. Although there was a trend show-

ing that the McConnell regimen could have been more effective

than the Coumans bandage, the only statistically significant dif-

ference between the groups was found in rating of satisfaction of

applied therapy. The weighted mean difference (WMD) between

the groups was 3.3 (95%CI 0.5 to 6.1) in favour of the McConnell

regimen.

Pain was measured during ascending and descending stairs, after

prolonged sitting and during squatting. It was rated on an 11

point numeric rating scale (0-10). Both groups showed a reduction

in pain after six weeks. The McConnell group presented a larger

mean reduction in pain rating, but none of the differences were

statistically significant. The WMDs between groups for decrease

in pain for ascending and descending stairs was 0.3 (95% CI -2.9

to 3.5); prolonged sitting, 1.2 (95% CI -2.7 to 5.1) and squatting,

2.0 (95% CI -1.2 to 5.2). Functional improvement was assessed

by use of the Ranawatt score and the Kujala score. No significant

difference in mean improvement was identified for either score.

The WMD between the groups for improvement in the Ranawatt

score was 7.9 (95% CI -2.7 to 18.5) and the Kujala score, 11.0

(95% CI -2.2 to 24.2).

An improved isokinetic muscle strength was reported at both 300°

per second and 60° per second for both groups, with the only

significant result reported at 300° for flexion, in favour of the Mc-

Connell group (WMD 15.1 95% CI 0.3 to 29.9). The remain-

ing WMDs between the groups for improvement in isokinetic

strength were, at 300° per second, 7.6 (95% CI -11.1 to 26.3) for

extension; and at 60° per second 5.4 (95% CI -6.4 to 17.2) for

extension and 0.5 (95% CI -13.2 to 14.2) for flexion.

PALUMBO BRACE VERSUS CHO-PAT STRAP

Miller 1997 compared the Palumbo brace with the Cho-Pat knee

strap, both in conjunction with a physical therapy programme

and both were compared with a group exposed only to the co-

intervention. Fifty-nine subjects participated at baseline. Eight

subjects were lost to follow-up and were not taken into account

for statistical analysis. Although the study describes a follow-up

period of eight weeks, only data from the second (one week) and

third visit (two or three weeks) were presented.

3Orthotic devices for treating patellofemoral pain syndrome (Review)

Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Pain and motivation were both assessed on a 100mm VAS. No

statistically significant differences between groups were identified

for either of these outcomes measures. The calculated WMDs

between the groups for the average decrease in pain between the

first and the second visit were 0.4 (95% CI -1.1 to 1.9) when

comparing the no-brace group to the Palumbo group; 0.9 (95% CI

-0.6 to 2.4) when comparing the no-brace group to the Cho-Pat

group, and 0.5 (95% CI -1.1 to 2.0) when comparing the Palumbo

group to the Cho-Pat group. The calculated WMDs between the

groups for the average decrease in pain between the first and third

visit were 1.4 (95% CI -0.5 to 3.3) comparing the no-brace group

to the Palumbo group; 1.1 (95% CI -1.1 to 3.3) comparing the

no-brace group with the Cho-Pat group, and 0.26 (95% CI -1.8

to 2.3) comparing the Palumbo group with the Cho-Pat group.

PROTONICS ORTHOSIS VERSUS NO TREATMENT

Timm 1998 used a sample of 100 participants to determine the

difference in effect of using a Protonics orthosis for treating PFPS

compared with no treatment. During a four week follow-up pe-

riod, pain associated with ascending and descending stairs, rising

from sitting, squatting, and prolonged sitting, was assessed by use

of a 100mm visual analogue scale (VAS). Functional improvement

was assessed by use of the 0 to 100 point Kujala score. Further-

more, the so-called patellofemoral congruence angle (PFCA) was

determined by use of a Merchant x-ray view. All outcome measures

presented statistically significant differences between the groups

in favour of the Protonics orthosis.

The WMDs between the groups for decrease in pain were 3.2

(95% CI 2.8 to 3.6), for functional improvement assessed by the

Kujala score 45.6 (95% CI 43.4 to 47.7) and for change in PFCA

-17.2 (95% CI -20.2 to -14.1).

HOME EXERCISE VERSUS SAME WITH MONITORED

THERAPY VERSUS SAME WITH McCONNELL TAPE AND

BIOFEEDBACK

Harrison 1999 compared three strategies for treating

patellofemoral pain syndrome. At baseline, 113 participants were

randomly assigned to one of the three trial arms consisting of 1)

a home exercise programme; 2) a home exercise programme in

conjunction with stretching of tight lateral structures monitored

by a physical therapist; and 3) a home exercise programme in con-

junction with stretching of tight lateral structures, application of

McConnell tape and biofeedback. Treatment was maintained for

four weeks.

Five types of outcome measures were used to determine the treat-

ment effect. A 100mm VAS was used to measure worst and usual

pain. Functional improvement was measured by use of the Reid

Patellofemoral Function Scale (PF scale) and by use of a modified

version of the Chesworth Functional Index Questionnaire (FIQ).

Furthermore, a subjective clinical change was measured and a step

performance test was conducted. Assessments were performed at

four weeks of treatment and after three months, six months and

one year without treatment.

Significant differences were found for decrease in worst and usual

pain, clinical change and FIQ scores at four weeks follow-up pe-

riod when comparing groups two and three. On all three measures,

group three scored significantly better than two. Only sufficient

data on pain, patellofemoral scale scores and step test were pro-

vided for further statistical analysis. The WMDs between group

two and three at one month follow-up were 1.6 (95% CI 0.4,

2.8) for decrease in worst pain, and 1.2 (95% CI 0.2 to 2.1) for

decrease in usual pain. At one month, the WMD between groups

on the PF scale was significantly in favour of group three (WMD

10, 95% CI 2.07 to 17.93).

No significant differences were found between the groups for the

other follow-up periods of three months, six months or one year,

or patellofemoral scale scores and step test outcome.

CONCENTRIC VERSUS ECCENTRIC EXERCISE PRO-

GRAMME

Gaffney 1992 conducted a multi-centred trial in order to deter-

mine the difference in effect between a concentric exercise treat-

ment programme and an eccentric exercise treatment programme,

in conjunction with tape application. A follow-up period of six

weeks was conducted. At baseline 72 participants were randomised

to the two trial arms, and 60 participants completed the study.

Reasons given for withdrawal were that it was too far to attend (one

case), work commitments/travel (two cases) and two people with-

drew due to another injury. The reason for the seven remaining

withdrawals were unknown. Pain was partly measured by use of

an 11 point numeric VAS and partly by use of a three point rating

scale. Furthermore, improvement in function was also scored on

a three point rating scale. Subjective success was measured using

a dichotomous system. No statistically significant differences be-

tween groups were identified for any of these outcome measures.

The trial report only provided adequate data on subjective success,

with a non-significant difference between groups in favour of the

concentric programme (RR 0.84, 95% CI 0.66 to 1.07).

In conclusion, the reviewed level C research based evidence sug-

gested that the Protonics orthosis was effective for decreasing pain

(WMD 3.2; 95% CI 2.8 to 3.6), functional improvement (WMD

45.6; 95% CI 43.4 to 47.7) and change in PFCA (WMD 17.2;

95% CI 14.1 to 20.3) when compared with no treatment at six

weeks follow-up; secondly, a comprehensive exercise and stretch-

ing programme including tape application was significantly supe-

rior to a monitored programme without tape application on de-

crease in worst pain (WMD 1.6; 95% CI 0.4 to 2.8) and usual

pain (WMD 1.2; 95% CI 0.2 to 2.1) and on functional improve-

ment questionnaire scores (WMD 10, 95% CI 2.07 to 17.93) at

four weeks follow-up; thirdly, the McConnell regimen was supe-

rior when compared to the Coumans bandage for satisfaction rate

(WMD 3.3; 95% CI 0.5 to 6.1) at six weeks follow-up; fourthly,

4Orthotic devices for treating patellofemoral pain syndrome (Review)

Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

there were no significant differences in effect between the Cho-Pat

strap, the Palumbo brace and no brace at three weeks follow-up;

and lastly, there were no significant differences in effect between

a concentric training programme and an eccentric training pro-

gramme both in conjunction with tape application at six weeks

follow-up.

D I S C U S S I O N

The lack of properly described randomised clinical trials in this

field is disappointing for the overall assessment of orthotics for

patellofemoral pain syndrome. Initially, we assessed the method-

ological quality of the 10 trials which met our inclusion criteria.

In general the methodological quality of these trials varied from

moderate to poor. The mean overall quality score of the retrieved

trials was 12.4 (10 to 17 out of a maximum score of 22). Only one

trial (Eng 1993) was graded as a high quality trial and achieved 17

points (77%).

Seven trials (Arcand 1998; Eng 1993; Finestone 1993; Eburne

1996; Kowall 1996; Handfield 2000; Cameron 1997) have been

placed in Studies Awaiting Assessment due to insufficient data

provision or needing further classification, and may be included

in a future update of the review. The methodological quality of

the five remaining studies (Gaffney 1992; Wijnen 1996; Timm

1998; Miller 1997; Harrison 1999) appeared to be moderate to

poor.

Four of the five included trials did not describe the means of se-

lecting who received the intervention of interest. Therefore, it re-

mained unclear if adequate concealment of allocation was per-

formed. By leaving the selection of treatment up to the providers

and the recipients of care, decisions on whether or not to partic-

ipate can be related to prognosis and probable responsiveness to

treatment. This could cause an overestimation of the treatment

effect. That is, the effectiveness of the presented strategies might

be overestimated. Motivation is also likely to be higher in the par-

ticipating patients when compared to the total patient population.

All trials presented methodological flaws on blinding of both pa-

tients (item E) and treatment providers (item F). In trials concern-

ing physical rehabilitation and orthotic devices blinding seems to

be difficult to achieve. As these items are associated with the in-

troduction of performance bias (Karlowski 1975; Colditz 1989;

Schulz 1995), it is unlikely the possibility of this type of bias can

be eliminated completely in these trials.

The four to eight week follow-up periods most commonly used

in these trials might not be sufficient to detect clinically relevant

changes. Based on our own clinical experience we feel that the

short-term follow-up period should involve at least eight weeks.

Furthermore, it would be interesting to see if a positive effect is

maintained for a longer period after treatment.

To increase the evidence base for practice, there is an obvious need

for high quality, appropriately powered and reported RCTs on this

topic.

To avoid flawed reporting of a trial, it is recommended that future

trials adhere to the standards of reporting presented in the CON-

SORT statement (Begg 1996; Altman 2001). This will lead to a

higher standard of trial reporting. It should increase the applicabil-

ity of the trial report in practice and allow incorporation into sys-

tematic reviews. Furthermore, newly conducted trials should use

adequate outcome measures to evaluate effectiveness of treatment

strategies. They should have sufficient statistical power to detect

clinically relevant changes in outcome measures. In addition there

should be greater uniformity of outcome measures. These mea-

sures will increase the comparability of RCTs and may contribute

to avoidance of statistical heterogeneity.

In a review on physical rehabilitation, Karjalainen 2002 advocated

the evaluation of baseline expectations for the rehabilitation re-

sponse of both patients and therapists for both the intervention

and control groups. In addition, adequate methods of allocation

concealment should be applied to avoid any manipulation of the

randomisation process and it is recommended that future trials in-

volve a short-term (less than eight weeks), intermediate-term and

a long-term follow-up period.

A U T H O R S ’ C O N C L U S I O N S

Implications for practice

As the strength of retrieved evidence was graded as limited, it seems

inappropriate to make any clinical recommendation concerning

the use of knee and foot orthotics in the conservative treatment of

patellofemoral pain syndrome. At present the decision on whether

or not to use orthotic devices depends on the patient’s preference

and the clinician’s clinical experience. Current trial results should

be interpreted with caution.

Implications for research

There is an obvious need for high quality trials to provide clear

evidence for treatment in this area. It is important that the ef-

fectiveness of orthotic devices is assessed in such a way that bias

is reduced to a minimum. Future RCTs in this field should use

a high quality methodological design. Sufficient statistical power

is needed to show statistically significant differences in clinically

meaningful changes of relevant outcome measures. Furthermore,

studies should include an active systematic follow-up of patients

focused on short-, intermediate- and long-term effects. Clear de-

scription of data and methodology contributes to a valuable inter-

pretation of the trial’s results and conclusions. To achieve this, it

is strongly recommended that journal editors should rely on the

CONSORT statement when considering a trial for being pub-

lished (Begg 1996; Altman 2001).

5Orthotic devices for treating patellofemoral pain syndrome (Review)

Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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

This study served as the basis for a Master’s thesis for the degree

of a Master of Science in Physiotherapy at the Department of

Physiotherapy, Faculty of Physical Education & Physiotherapy at

the Katholieke Universiteit, Leuven. The thesis was supervised by

Prof R Lysens and G Aufdemkampe, MSc PT.

We would like to thank Dr Helen Handoll and Ms Leeann Morton

for their help and advice in constructing the protocol. We also

would like to thank Prof Dan Carr, Prof Bill Gillespie, Mr Peter

Herbison, Dr Bruce Arroll, Dr John Kellett, Mrs Lesley Gillespie,

Prof Rajan Madhok and Prof Marc Swiontkowski for their helpful

comments at editorial review.

We thank Mr Wolbert van den Hoorn for his contribution to the

search for trials.

R E F E R E N C E S

References to studies included in this review

Gaffney 1992 {published data only}

Gaffney K, Fricker P, Dwyer T, Barret E, Skibinski K,

Coutts R. Patellofemoral joint pain: A comparison of two

treatment programmes. Excel 1992;8:179–189.

Harrison 1999 {published data only}

Harrison EL, Sheppard MS, McQuarrie AM. A randomised

controlled trial of physical therapy treatment programs in

patellofemoral pain syndrome. Physiotherapy Canada 1999;

51(2):93–100,106.

Miller 1997 {published data only}

Miller MD, Hinkin DT, Wisnowski JW. The efficacy of

orthotics for anterior knee pain in military trainees. A

preliminary report. American Journal of Knee Surgery 1997;

10(1):10–13.

Timm 1998 {published data only}

Timm KE. Randomized controlled trial of Protonics on

patellar pain, position, and function. Medicine and Science

in Sports and Exercise 1998;30(5):665–670.

Wijnen 1996 {published data only}

Wijnen LACM, Lenssen AF, Kuys-Wouters YSM,

De Bie RA, Borghouts JAJ, Bulstra SK. McConnel-

therapy versus Coumansbandage in Patellofemoral

Pain [McConnel–therapie versus Coumansbandage bij

patellofemorale pijnklachten]. Nederlands Tijdschrift voor

Fysiotherapie 1996;Sept(Special):12–17.

References to studies excluded from this review

Beetsma 1996

Beetsma AJ, Zomerdijk TE, Van Horn JR, Van Wijck R.

Funktionele behandeling van het Patellofemoraal Pijnsyndroom

bij adolescente meisjes - Is het McConnellprogramma efectief?

- Een pilot studie [Functional treatment of the patellofemoral

pain syndrome in adolescent girls - is the McConnell program

efficacious? - a pilot study ] [thesis]. Groningen (NL): RUG

Univ of Groningen, 1996.

BenGal 1997

BenGal S, Lowe J Mann G, Finsterbush A, Matan Y. The

role of the knee brace in the prevention of anterior knee

pain syndrome. American Journal of Sports Medicine 1997;

25(1):118–122.

Hoefsloot 2000

Hoefsloot W, Groenenberg M, Hopman MTE. Protonics:

A new therapy for the patellofemoral pain syndrome?

[Protonics: een nieuwe therapie voor het patellofemorale

pijn syndroom?]. Geneeskunde en Sport 2000;33(1):17–24.

Moller 1989

Moller BN, Krebs B. Dynamic knee brace in the treatment

of patellofemoral disorders. Archives of Orthopaedic and

Trauma Surgery 1986;104(6):377–379.

References to studies awaiting assessment

Arcand 1998

Arcand MA, Klion M, Jabbour A, Reider B, Gray D.

The efficacy of McConnell taping for intermediate pain

relief in patellofemoral pain syndrome: preliminary results

[abstract]. Journal of Bone and Joint Surgery. British Volume

1998;80 Suppl 1:7–8.

Eburne 1996

Eburne J, Bannister G. The McConnell regimen versus

isometric quadriceps exercises in the management of

anterior knee pain. A randomised prospective controlled

trial. The Knee 1996;3:151–153.

Eng 1993

Eng JJ, Pierrynowski MR. Evaluation of soft foot orthotics

in the treatment of patellofemoral pain syndrome. Physical

Therapy 1993;73(2):62–68.

6Orthotic devices for treating patellofemoral pain syndrome (Review)

Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Finestone 1993

Finestone A, Radin EL, Lev B, Shlamkovitch N, Wiener

M, Milgrom C. Treatment of overuse patellofemoral pain.

Prospective randomized controlled clinical trial in a military

setting. Clinical Orthopaedics and Related Research 1993;

293:208–10.

Handfield 2000

Handfield T, Kramer J. Effect of McConnell taping on

perceived pain and knee extensor torques during isokinetic

exercise performed by patients with patellofemoral pain

syndrome. Physiotherapy Canada 2000;52(1):39–44.

Kowall 1996∗ Kowall MG, Kolk G, Nuber GW, Cassisi JE, Stern SH.

Patellar taping in the treatment of patellofemoral pain. A

prospective randomized study. American Journal of Sports

Medicine 1996;24(1):61–66.

Additional references

Altman 2001

Altman DG, Schulz KF, Moher D, Egger M, Davidoff F,

Elbourne D, et al.The revised CONSORT statement for

reporting randomized trials: explanation and elaboration.

Annals of Internal Medicine 2001;134(8):663–694.

Arroll 1997

Arroll B, Ellis-Pegler E, Edwards A, Sutcliffe G.

Patellofemoral Pain Syndrome: A critical review of the

clinical trials on nonoperative therapy. American Journal of

Sports Medicine 1997;25:207–212.

Badalamente 1989

Badalamente MA, Cherney SB. Periosteal and vascular

innervation of the human patella in degenerative joint

disease. Seminars in Arthritis and Rheumatism 1989;18(4

Suppl 2):61–66.

Begg 1996

Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin

I, et al.Improving the quality of reporting of randomized

controlled trials. The CONSORT statement. JAMA 1996;

276(8):637–639.

Biedert 2001

Biedert RM, Kernen V. Neurosensory Characteristic of the

Patellofemoral Joint: What is the Genesis of Patellofemoral

Pain?. Sports Medicine and Arthroscopy Review 2001;9(4):

295–300.

Brody 1998

Brody LT, Thein JM. Nonoperative treatment for

patellofemoral pain. Journal of Orthopaedic and Sports

Physical Therapy 1998;28(5):336–343.

Clarke 2001a

Clarke M, Oxman AD, editors. Optimal search strategy

for RCTs. Cochrane Reviewers Handbook 4.1.2 [updated

March 2001]; Appendix 5c. In: The Cochrane Library,

Issue 2, 2001. Oxford: Update Software. Updated

quarterly.

Clarke 2001b

Clarke M, Oxman AD, editors. Assessment of study quality.

Cochrane Reviewers Handbook 4.1.2 [updated March

2001]; Section 6. In: The Cochrane Library, Issue 2, 2001.

Oxford: Update Software. Updated quarterly.

Colditz 1989

Colditz GA, Miller JN, Mosteller F. How study design

affects outcomes in comparisons of therapy. I: Medical.

Statistics in Medicine 1989;8:441–454.

Dye 2001

Dye SF. Therapeutic implications of a tissue homeostasis

approach to patellofemoral pain. Sports Medicine and

Arthroscopy Review 2001;9(4):306–311.

Gerrard 1989

Gerrard B. The patello-femoral pain syndrome: A clinical

trial of the McConnell programme. Australian Journal of

Physiotherapy 1989;35(2):71–79.

Grelsamer 1998

Grelsamer RP, Klein JR. The biomechanics of the

patellofemoral joint. Journal of Orthopaedic and Sports

Physical Therapy 1998;28(5):286–298.

Harrison 1999

Harrison EL, Sheppard MS, McQuarrie AM. Randomised

controlled trial of physical therapy programs in

patellofemoral pain syndrome. Physiotherapy Canada 1999;

51(2):93–106.

Holmes 1998

Holmes SW, Glancy WG. Clinical classification of

patellofemoral pain and dysfunction. Journal of Orthopaedic

and Sports Physical Therapy 1998;28(5):299–306.

Jackson 2001

Jackson AM. Review article: anterior knee pain. The Journal

of Bone and Joint Surgery. British Volume 2001;83-B(7):

937–948.

Jadad 1996

Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds

DJ, Gavaghan DJ, et al.Assessing the quality of reports of

randomized clinical trials: is blinding necessary?. Clinical

Controlled Trials 1996;17(1):1–12.

Karjalainen 2002

Karjalainen K, Malmivaara A, van Tulder M, Roine R,

Jauhiainen M, Hurri H, et al.Biopsychosocial rehabilitation

for upper limb repetitive strain injuries in working age

adults (Cochrane review). The Cochrane Library 2002, Issue

2.

Karlowski 1975

Karlowski TR, Chalmers TC, Frenkel LD, Kapikian AZ,

Lewis TL, Lynch JM. Ascorbic acid for the common cold.

A prophylactic and therapeutic trial. JAMA 1975;231(10):

1038–1042.

Klingman 1997

Klingman RE, Liaos SM, Hardin KM. The effect of subtalar

joint posting on patellar glide position in subjects with

excessive rearfoot pronation. Journal of Orthopaedic and

Sports Physical Therapy 1997;25(3):185–191.

7Orthotic devices for treating patellofemoral pain syndrome (Review)

Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Kujala 1993

Kujala UM, Jaakkola LH, Koskinen SK, Taimela S, Hurme

M, Nelimarkka O. Scoring of patellofemoral disorders.

Arthroscopy 1993;9(2):159–163.

Landis 1977

Landis JR, Koch GG. An application of hierarchical kappa-

type statistics in the assessment of majority agreement

among multiple observers. Biometrics 1977;33(2):363–374.

Lindberg 1986

Lindberg U, Lysholm J, Gillquist J. The correlation between

arthroscopic findings and the patellofemoral pain syndrome.

Arthroscopy 1986;2(2):103–107.

Lysholm 1982

Lysholm J, Gillquist J. Evaluation of knee ligament surgery

results with special emphasis on use of a scoring scale.

American Journal of Sports Medicine 1982;10(3):150–154.

Natri 1998

Natri A, Kannus P, Jarvinen M. Which factors predict

the long-term outcome in chronic patellofemoral pain

syndrome? A 7-year prospective follow-up study. Medicine

and Science in Sports and Exercise 1998;30(11):1572–1577.

Nissen 1998

Nissen CW, Cullen MC, Hewett TE, Noyes FR.

Physical and arthroscopic examination techniques of the

patellofemoral joint. Journal of Orthopaedic and Sports

Physical Therapy 1998;28(5):277–285.

Powers 1998

Powers CM. Rehabilitation of patellofemoral joint disorders:

a critical review. Journal of Orthopaedic and Sports Physical

Therapy 1998;28(5):345–353.

Puniello 1993

Puniello MS. Iliotibial band tightness and medial patellar

glide in patients with patellofemoral dysfunction. Journal

of Orthopaedic and Sports Physical Therapy 1993;17(3):

144–148.

Revman 2000

Review Manager (RevMan) [Computer program]. Version

4.1 for Windows. Oxford, England: The Cochrane

Collaboration, 2000. CD-ROM, Internet.

Saxena 1998

Saxena A, Haddad J. The effect of foot orthoses on

patellofemoral pain syndrome. The Lower Extremity 1998;5

(2):95–102.

Schulz 1994

Schulz KF, Chalmers I, Grimes DA, Altman DG. Assesssing

the quality of randomization from reports of controlled

trials published in obstetrics and gynaecology journals.

JAMA 1994;272(2):125–128.

Schulz 1995

Schulz KF, Chalmers I, Hayes RJ, Altman D. Empirical

evidence of bias. JAMA 1995;273(5):408–412.

Scunderi 1992

Scunderi GR. Surgical treatment for patellar instability.

Orthopedic Clinics of North America 1992;23(4):619–630.

Shellock 1994

Shellock FG, Mink JH, Deutch AL, Fox J, Molnar T,

Kvitne R, et al.Effect of patellar realignment brace on

patellofemoral relationships: evaluation with kinematic MR

imaging. Journal of Magnetic Resonance Imaging 1994;4(4):

590–594.

Shelton 1991

Shelton GL, Thigpen LK. Rehabilitation of patellofemoral

dysfunction: a review of literature. Journal of Orthopaedic

and Sports Physical Therapy 1991;14(6):243–249.

Van der Velden 1991

Van der Velden J, Bakker de DH, Claessens AAMC,

Schellevis FG. Een nationale studie naar ziekten en

verrichtingen in de huisartsenpraktijk. Basisrapport:

Morbiditeit in de huisartsenpraktijk [Morbidity in General

Practice. Dutch National Survey of General Practice].

Utrecht: Nederlands Instituut voor Onderzoek van de

Eerstelijnsgezondheidszorg, 1991.

Van Linge 1995

Van Linge B, Heijboer MP. Clinical examination. In:

Linden AJ van der, Cleassens H editor(s). Leerboek

orthopedie. 8. Houten/ Diegem: Bohn Stafleu Van

Loghum, 1995:331–342.

Van Tulder 1997

Van Tulder MW, Assendelft WJJ, Koes BWK, Bouter LM.

Methodologic guidelines for systematic reviews in the

Cochrane Collaboration Back Review Group for Spinal

Disorders. Spine 1997;22(20):2323–2330.

Verhagen 1998

Verhagen AP, De Vet HCW, De Bie RA, Kessels AGH, Boers

M, Knipschild PG. Balneotherapy and quality assessment:

interobserver reliability of the Maastricht criteria list and

the need for blinded quality assessment. Journal of Clinical

Epidemiology 1998;51(4):335–341.

Wilk 1998

Wilk KE, Davies GJ, Mangine RE, Malone TR.

Patellofemoral disorders: a classification system and

clinical guidelines for nonoperative rehabilitation. Journal

of Orthopaedic and Sports Physical Therapy 1998;28(5):

307–322.

Witvrouw 1996

Witvrouw E, Sneyers C, Lysens R, Victor J, Bellemans

J. Reflex response times of vastus medialis oblique and

vastus lateralis in normal subjects and in subjects with

patellofemoral pain syndrome. Journal of Orthopaedic and

Sports Physical Therapy 1996;24(3):160–165.

Witvrouw 2000

Witvrouw E, Lysens R, Bellemans J, Cambier D,

Vanderstraeten G. Intrinsic risk factors for the development

of anterior knee pain in an athletic population. A two-

year prospective study. American Journal of Sports Medicine

2000;28(4):480–489.

Zomerdijk 1998

Zomerdijk TE, Beetsma AJ, Dekker R, Van Wijck R, Van

Horn JR. Conservative treatment of the patellofemoral pain

8Orthotic devices for treating patellofemoral pain syndrome (Review)

Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

syndrome -a systematic review of literature [Conservative

behandeling van het patellofemoraal pijnsyndroom – Een

systematisch literatuuronderzoek]. Nederlands Tijdschrift fur

Fysiotherapie 1998;108(4):95–102.∗ Indicates the major publication for the study

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

External sources of support

• No sources of support supplied

Internal sources of support

• No sources of support supplied

N O T E S

The title of the protocol was “Orthotics for anterior knee pain”.

I N D E X T E R M S

Medical Subject Headings (MeSH)

Arthralgia [∗therapy]; ∗Femur; ∗Orthotic Devices; ∗Patella; Randomized Controlled Trials as Topic; Syndrome

MeSH check words

Humans

9Orthotic devices for treating patellofemoral pain syndrome (Review)

Copyright © 2008 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.