Research question
This summary of a Cochrane review presents what we know from research about the effects of braces and foot/ankle orthoses in the treatment of patients with osteoarthritis of the knee. We searched for evidence up to March 2014. We found 13 studies (n = 1356) and included in this update six additional studies (n = 529 participants).
Study characteristics
We included studies reporting results in patients with early to severe knee OA (Kellgren & Lawrence grade I-IV) treated with a knee brace (valgus knee brace, neutral brace, neoprene sleeve) or an orthosis (laterally or medially wedged insole, neutral insole, variable or constant stiffness shoe) or given no treatment.
Background: What is osteoarthritis and what are braces and orthoses?
Osteoarthritis is the most common form of arthritis that can affect the hands, hips, shoulders and knees. In osteoarthritis, the cartilage that protects the ends of bones breaks down, causing pain and swelling. Osteoarthritis can occur in different areas of the knee or can affect the whole knee. Depending on the area, osteoarthritis can change the alignment of joints.
Braces and orthoses are devices that you wear to support your knee joint. Orthoses are insoles that fit comfortably inside your shoes. Braces are made of combinations of metal, foam, plastic, elastic material and straps. A knee brace can be fitted specially for the person wearing it.
Key results
This review shows the following in people with osteoarthritis of the knee.
Wearing a knee brace compared with no brace:
• may result in little or no difference in reducing pain and improving knee function and quality of life after 12 months (low-quality evidence); and
• causes many patients to stop their initial treatment because of lack of effect in both groups.
Stiffness and treatment failure (need for surgery) were not reported.
Wearing a laterally wedged insole compared with no insole:
• may result in little or no difference in reducing pain (low-quality evidence).
Function, stiffness, health-related quality of life, treatment failure and side effects were not reported.
Wearing a laterally wedged insole compared with wearing a neutral insole:
• probably results in little or no difference in reducing pain and improving function, stiffness and quality of life after 12 months (moderate-quality evidence).
Treatment failure and side effects were not reported.
Wearing a laterally wedged insole compared with a valgus knee brace:
• may result in little or no difference in reducing pain and improving function after sx months (low-quality evidence).
Stiffness, health-related quality of life, treatment failure and side effects were not reported
We often do not have precise information about side effects and complications. Side effects may include pain in the back of the knee, low back pain, foot sole pain or skin irritation.
Quality of the evidence
• Low-quality evidence suggests that people with OA who use a knee brace may have little or no reduction in pain, improved knee function and improved quality of life.
• Moderate-quality evidence suggests that people with OA of the knee who wear laterally wedged insoles or neutral insoles probably have little or no improvement in pain, function and stiffness.
Evidence was inconclusive for the benefits of bracing for pain, stiffness, function and quality of life in the treatment of patients with medial compartment knee OA. On the basis of one laterally wedged insole versus no treatment study, we conclude that evidence of an effect on pain in patients with varus knee OA is lacking. Moderate-quality evidence shows lack of an effect on improvement in pain, stiffness and function between patients treated with a laterally wedged insole and those treated with a neutral insole. Low-quality evidence shows lack of an effect on improvement in pain, stiffness and function between patients treated with a valgus knee brace and those treated with a laterally wedged insole. The optimal choice for an orthosis remains unclear, and long-term implications are lacking.
Individuals with osteoarthritis (OA) of the knee can be treated with a knee brace or a foot/ankle orthosis. The main purpose of these aids is to reduce pain, improve physical function and, possibly, slow disease progression. This is the second update of the original review published in Issue 1, 2005, and first updated in 2007.
To assess the benefits and harms of braces and foot/ankle orthoses in the treatment of patients with OA of the knee.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE (current contents, HealthSTAR) up to March 2014. We screened reference lists of identified trials and clinical trial registers for ongoing studies.
Randomised and controlled clinical trials investigating all types of braces and foot/ankle orthoses for OA of the knee compared with an active control or no treatment.
Two review authors independently selected trials and extracted data. We assessed risk of bias using the 'Risk of bias' tool of The Cochrane Collaboration. We analysed the quality of the results by performing an overall grading of evidence by outcome using the GRADE (Grades of Recommendation, Assessment, Development and Evaluation) approach. As a result of heterogeneity of studies, pooling of outcome data was possible for only three insole studies.
We included 13 studies (n = 1356): four studies in the first version, three studies in the first update and six additional studies (n = 529 participants) in the second update. We included studies that 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. Seven studies had low risk, two studies had high risk and four studies had unclear risk of selection bias. Five studies had low risk, three studies had high risk and five studies had unclear risk of detection bias. Ten studies had high risk and three studies had low risk of performance bias. Nine studies had low risk and four studies had high risk of reporting bias.
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, low-quality evidence) showed lack of evidence of an effect on visual analogue scale (VAS) pain scores (absolute percent change 0%, mean difference (MD) 0.0, 95% confidence interval (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%, risk ratio (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, low-quality evidence) 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, moderate-quality evidence), 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.