Bennell 2011.
Methods | RCT; computer‐generated block randomisation | |
Participants | Painful medial knee osteoarthritis: n = 200 Male/ female: 82/118 Mean age (years): 64 Mean BMI (kg/m2): 29.2 Mean varus (degrees): 181 Grade of medial OA according to Kellgren & Lawrence: II = 95, III = 105 |
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Interventions | I = full‐length (5º) wedged insole into shoe (n = 103) vs C = neutral insole into shoe (n = 97) Follow‐up: 12 months |
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Outcomes | NRS scale (pain), WOMAC scale, physical activity scale for the elderly, average number of steps taken per day | |
Notes | No competing interests | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Participants were stratified by disease severity (Kellgren and Lawrence grades 2 and 3) and sex and randomly allocated in permuted blocks of 6 to 12" |
Allocation concealment (selection bias) | Low risk | Quote: "An independent investigator used a computer program to generate the randomisation sequence a priori. Allocation was sealed in opaque and consecutively numbered envelopes held centrally. Envelopes were opened sequentially by an independent person" |
Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "a double blind randomised controlled trial" |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Participants were informed that two types of insoles were being compared but the insoles and study hypotheses were not described" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "A blinded examiner assessed the participants at baseline and 12 months" according to patient‐reported outcome measures; participants were blinded as well |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Intention‐to‐treat |
Selective reporting (reporting bias) | Low risk | Complete data were reported |