Toda 2001.
Methods | RCT; randomisation performed by date of birth. Blinded assessments of level of pain according to VAS, Lequesne index, radiographic outcome | |
Participants | American College of Rheumatology criteria for knee osteoarthritis (n = 90)
All female
Mean age (years): 65
Mean varus (FTA; degrees): 181 Degree of OA according to Kellgren & Lawrence: II = 55, III = 27, IV = 8 |
|
Interventions | I = strapped insole (n = 46) vs C = lateral wedge insole (n = 44) Follow‐up: 8 weeks, 6 months and 2 years | |
Outcomes | VAS, Lequesne (pain) index score, radiographic changes | |
Notes | In Table 3 of the first publication, median value of final VAS score in strapped insole group is incorrect No between‐groups analysis was performed | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Quote: "Randomisation was performed by date of birth" |
Allocation concealment (selection bias) | High risk | Quote: "Randomisation was performed by date of birth" |
Blinding (performance bias and detection bias) All outcomes | High risk | Participants were not blinded; outcome assessors were blinded; study used patient‐reported outcome measures; radiographic changes were measured blinded |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants were not blinded to the intervention. Research nurse was blinded to objectives of the study |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Study used patient‐reported outcome measures (PROMs). Outcome assessor of PROMS, namely, the participant, was not blinded in this study. However participant and research nurse were blinded to objectives of the study |
Incomplete outcome data (attrition bias) All outcomes | High risk | No intention‐to‐treat analysis |
Selective reporting (reporting bias) | Low risk | Complete data were reported |