Effect of Orthotics on Exercise for Patellofemoral Pain
A literature search was conducted in MEDLINE, CINAHL, EMBASE, Cochrane and PEDro by two independent researchers (MvM and NMS). Wherever possible, the Cochrane Library search filter for randomised controlled trials (RCT)and controlled clinical trials (CCT) was applied to make a restriction for the design. If it was impossible to use the filter in the database, the specific limits options were used for RCT and CCT. Studies were collected from 1990 up to January 2010 with a language restriction for English, German and Dutch studies (online appendix 1). Finally, the reference lists of the included articles were searched for more relevant articles.
Studies were included if they met the following criteria: (1) RCT or CCT. (2) The study population had to include patients diagnosed with PFPS or anterior knee pain. (3) The intervention had to consist of exercise therapy aiming at muscle strengthening and stretching exercises, combined with foot or knee orthotics (including tape, braces and insoles). The control group had to receive an identical exercise programme with or without sham orthotics. (4) The outcome measures assessed were pain and function either reported by the patient using a questionnaire or by the assessor using an objective performance measure of the knee.
Studies were excluded when they did not fulfil the above-mentioned inclusion criteria on design, intervention and outcome.
Two review authors (NMS, MvM) working independently from one another examined all citations (including titles and abstracts) from the electronic search. Full articles were obtained for those citations thought to fulfil the inclusion criteria. A third reviewer (SMAB-Z) was consulted if consensus was not reached.
The risk of bias assessment was conducted using the 12 criteria recommended by the Cochrane Back Review Group and evaluated independently by two researchers (RvL and NMS) (online appendix 2). The 12 questions were answered with 'yes', 'no' or 'unclear'. If there was a difference in the scores between the assessors, agreement was reached after discussion. Studies with six or more positive items were considered to have a low risk of bias. This cut-off point is supported by empirical evidence.
Agreement between the two authors was calculated by Cohen's κ. Values of κ between 0.40 and 0.59 have been considered to reflect fair agreement, between 0.60 and 0.74 to reflect good agreement and 0.75 or more to reflect excellent agreement.
Data extraction was performed independently by two researchers (SMAB-Z and NMS). The following data were extracted: study design, baseline characteristics, duration of the complaints, duration and specific details of the intervention, outcome measures and results. Data were extracted for short (0−12 weeks) and long-term (>12 weeks) outcomes. The change scores over time were extracted from the studies or in the absence calculated for the orthotic (O) and the control (C) groups. Subsequently, the differences in change scores between O and C were extracted or calculated, together with a 95% CI. If the raw data were not presented in the study, data were extracted from the figures. The authors were not contacted for data that were not provided. If studies do not provide enough information to calculate the 95% CI, information about significant differences between the groups is abstracted from the studies. Effect sizes (ES) were calculated by dividing the mean difference between O and C by the pooled SD of the baseline scores, when available. Cohen labelled an ES small if d=0.20, medium if d=0.50 and large if d=0.80.
A qualitative data analysis was applied using a best evidence synthesis, consisting of five levels to assess the power of the results. A modified version recommended by the Cochrane Back Review Group was used and outlined below:
Methods
A literature search was conducted in MEDLINE, CINAHL, EMBASE, Cochrane and PEDro by two independent researchers (MvM and NMS). Wherever possible, the Cochrane Library search filter for randomised controlled trials (RCT)and controlled clinical trials (CCT) was applied to make a restriction for the design. If it was impossible to use the filter in the database, the specific limits options were used for RCT and CCT. Studies were collected from 1990 up to January 2010 with a language restriction for English, German and Dutch studies (online appendix 1). Finally, the reference lists of the included articles were searched for more relevant articles.
Criteria for Considering Studies for This Review
Studies were included if they met the following criteria: (1) RCT or CCT. (2) The study population had to include patients diagnosed with PFPS or anterior knee pain. (3) The intervention had to consist of exercise therapy aiming at muscle strengthening and stretching exercises, combined with foot or knee orthotics (including tape, braces and insoles). The control group had to receive an identical exercise programme with or without sham orthotics. (4) The outcome measures assessed were pain and function either reported by the patient using a questionnaire or by the assessor using an objective performance measure of the knee.
Studies were excluded when they did not fulfil the above-mentioned inclusion criteria on design, intervention and outcome.
Two review authors (NMS, MvM) working independently from one another examined all citations (including titles and abstracts) from the electronic search. Full articles were obtained for those citations thought to fulfil the inclusion criteria. A third reviewer (SMAB-Z) was consulted if consensus was not reached.
Assessment of Risk of Bias in Included Studies
The risk of bias assessment was conducted using the 12 criteria recommended by the Cochrane Back Review Group and evaluated independently by two researchers (RvL and NMS) (online appendix 2). The 12 questions were answered with 'yes', 'no' or 'unclear'. If there was a difference in the scores between the assessors, agreement was reached after discussion. Studies with six or more positive items were considered to have a low risk of bias. This cut-off point is supported by empirical evidence.
Agreement between the two authors was calculated by Cohen's κ. Values of κ between 0.40 and 0.59 have been considered to reflect fair agreement, between 0.60 and 0.74 to reflect good agreement and 0.75 or more to reflect excellent agreement.
Data Extraction
Data extraction was performed independently by two researchers (SMAB-Z and NMS). The following data were extracted: study design, baseline characteristics, duration of the complaints, duration and specific details of the intervention, outcome measures and results. Data were extracted for short (0−12 weeks) and long-term (>12 weeks) outcomes. The change scores over time were extracted from the studies or in the absence calculated for the orthotic (O) and the control (C) groups. Subsequently, the differences in change scores between O and C were extracted or calculated, together with a 95% CI. If the raw data were not presented in the study, data were extracted from the figures. The authors were not contacted for data that were not provided. If studies do not provide enough information to calculate the 95% CI, information about significant differences between the groups is abstracted from the studies. Effect sizes (ES) were calculated by dividing the mean difference between O and C by the pooled SD of the baseline scores, when available. Cohen labelled an ES small if d=0.20, medium if d=0.50 and large if d=0.80.
Data Synthesis
A qualitative data analysis was applied using a best evidence synthesis, consisting of five levels to assess the power of the results. A modified version recommended by the Cochrane Back Review Group was used and outlined below:
Strong evidence—consistent findings among multiple low risk of bias RCT (vonsistency: ≥75% of the trials report the same findings).
Moderate evidence—consistent findings among multiple high risk of bias RCT and/or CCT and/or one low risk of bias RCT.
Limited evidence—one high risk of bias RCT and/or CCT or consistent findings among multiple CCT.
Conflicting evidence—inconsistent findings among multiple RCT and/or CCT.
No evidence from trials—no RCT or CCT could be found.
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