A Cochrane review [Abstract] 1 included 13 studies with a total of 1356 subjects. Studies reported results when study participants with early to severe knee OA (Kellgren & Lawrence grade I-IV) were treated with a knee brace (valgus knee brace, neutral brace or neoprene sleeve) or an orthosis (laterally or medially wedged insole, neutral insole, variable or constant stiffness shoe) or were given no treatment. The main comparisons included (1) brace versus no treatment; (2) foot/ankle orthosis versus no treatment or other treatment; and (3) brace versus foot/ankle orthosis.
Four studies compared brace versus no treatment, but only one provided useful data for meta-analysis at 12-month follow-up. One study (n = 117) showed lack of evidence of an effect on visual analogue scale (VAS) pain scores (absolute percent change 0%, MD 0.0, 95% CI -0.84 to 0.84), function scores (absolute percent change 1%, MD 1.0, 95% CI -2.98 to 4.98) and health-related quality of life scores (absolute percent change 4%, MD -0.04, 95% CI -0.12 to 0.04) after 12 months. Many participants stopped their initial treatment because of lack of effect (24 of 60 participants in the brace group and 14 of 57 participants in the no treatment group; absolute percent change 15%, RR 1.63, 95% CI 0.94 to 2.82. The other studies reported some improvement in pain, function and health-related quality of life (P value ≤ 0.001). Stiffness and treatment failure (need for surgery) were not reported in the included studies.
For the comparison of laterally wedged insole versus no insole, one study (n = 40) showed a lower VAS pain score in the laterally wedged insole group (absolute percent change 16%, MD -1.60, 95% CI -2.31 to -0.89) after nine months. Function, stiffness, health-related quality of life, treatment failure and adverse events were not reported in the included study.
For the comparison of laterally wedged versus neutral insole after pooling of three studies (n = 358), little evidence was found of an effect on numerical rating scale (NRS) pain scores (absolute percent change 1.0%, MD 0.1, 95% CI -0.45 to 0.65), Western Ontario-McMaster Osteoarthritis Scale (WOMAC) stiffness scores (absolute percent change 0.1%, MD 0.07, 95% CI -4.96 to 5.1) and WOMAC function scores (absolute percent change 0.9%, MD 0.94, 95% CI - 2.98 to 4.87) after 12 months. Evidence of an effect on health-related quality of life scores (absolute percent change 1.0%, MD 0.01, 95% CI -0.05 to 0.03) was lacking in one study (n = 179, moderate-quality evidence). Treatment failure and adverse events were not studied for this comparison in the included studies.
Data for the comparison of laterally wedged insole versus valgus knee brace could not be pooled. After six months' follow-up, no statistically significant difference was noted in VAS pain scores (absolute percent change -2.0%, MD -0.2, 95% CI -1.15 to 0.75) and WOMAC function scores (absolute percent change 0.1%, MD 0.1, 95% CI -7.26 to 0.75) in one study (n = 91, low-quality evidence); however both groups showed improvement. Stiffness, health-related quality of life, treatment failure and adverse events were not reported in the included studies for this comparison.
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