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. 2015 Mar 16;2015(3):CD004020. doi: 10.1002/14651858.CD004020.pub3

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
Interventions I = full‐length (5º) wedged insole into shoe (n = 103) vs C = neutral insole into shoe (n = 97)
Follow‐up: 12 months
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