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

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
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
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"