Barrios 2009.
Methods | RCT; block randomisation | |
Participants | Medial tibiofemoral OA: n = 66 Male/female: 29/37 Mean age (years): 62 Mean BMI (kg/m2): 33 Grade of OA according to Kellgren & Lawrence: II = 27, III = 24, IV = 15 |
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Interventions | I = full‐length (9º) wedged insole into shoe (n = 35) vs C = non‐custom neutral insole into shoe (n = 31) Follow‐up: 12 months |
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Outcomes | WOMAC, 6‐minute walking test, stair negotiation test | |
Notes | Mean and P values are presented, but SD values are missing | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "a block‐randomization was performed based on OA grade, gender, and age (greater or less than 55 years)" |
Allocation concealment (selection bias) | Low risk | Quote: "the allocation was done by an administrative assistant unaware of the methodologies used" |
Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "the subjects were blinded from group assignment" |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants assigned to the treatment group were tested to determine the amount of wedging Quote: "subjects who had no pain relieve (after wedging) were excluded from the study" |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding of assessors was not mentioned |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Intention‐to‐treat |
Selective reporting (reporting bias) | High risk | Quote: "subjects who had no pain relieve (after wedging) were excluded from the study" |