Background: Patients with osteoarthritis of the knee can be treated with a brace or orthosis (shoe insole). The main purpose of these aids is to reduce pain, improve physical function and, possibly, to slow disease progression.
Objectives: To assess the effectiveness of a brace or orthosis in the treatment of osteoarthritis of the knee.
Search strategy: We searched Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE (Current contents, Health STAR) up to October 2002. The reference lists of the publications in the identified trials were also screened.
Selection criteria: Extracted studies were included in the final analysis if they met the pre-defined inclusion criteria: 1) a randomised controlled clinical trial or a controlled clinical trial, 2) all patients had osteoarthritis of the knee, 3) the intervention in one of the studied groups was a brace or an orthosis.
Data collection and analysis: Two reviewers independently selected the trials and assessed the methodological quality using the Delphi-list and one additional question about care programs. Three reviewers independently extracted the data on the intervention, type of outcome measures, follow-up, loss to follow-up, and results, using a pre-tested standardized form. Study authors were contacted for additional information.
Main results: Four trials involving a total of 444 people were included in this review. One study investigated a knee brace and three studies examined different types of orthoses for medial compartment osteoarthritis of the knee. Two studies were of high methodological quality while the other two studies were low. Notably, the randomisation and the blinding procedures were either insufficient or not described. The follow-up period (six weeks to six months) was too short to demonstrate long-term results. Pooling was difficult primarily due to the heterogeneity of the data and the way the information was presented. The pain, stiffness and physical function (WOMAC and MACTAR) scores of a brace group showed greater improvement at six months compared with a neoprene sleeve group, which showed greater improvement compared with a control group. The numbers of days of non-steroidal anti-inflammatory drug (NSAID) intake decreased significantly (relative percentage difference 23.9%) compared with baseline in a group with laterally wedged insoles,and remained unchanged in the neutrally wedged group. Patient compliance with the laterally wedged insole was significantly better compared with the neutrally wedged insole. In one study, the Visual Analogue Pain (VAS) pain score was significantly decreased from baseline in a strapped insole group (RPD - 24%), but not in the traditional lateral wedge group, but this strapped insole showed more adverse effects (popliteal pain, low back pain, and foot sole pain) compared with the traditional lateral wedge insole. Pain during bed rest, after getting up, after getting up from seated position and walking distance was significantly improved in a subtalar strapped group compared with baseline, and no improvement was found in a sock type group. No studies were found that assessed the effectiveness of a brace or orthosis to treat lateral compartment osteoarthritis or general osteoarthritis of the knee, or that compared a knee brace with a wedge insole, or that compared a brace or orthosis with operative treatment.
Authors' conclusions: Based on one brace study we conclude there is limited evidence that: a brace has additional beneficial effect (WOMAC, MACTAR, function tests) for knee osteoarthritis compared with medical treatment alone.(Silver) a sleeve has additional beneficial effect (WOMAC, function tests) for knee osteoarthritis compared with medical treatment alone.(Silver) a brace is more effective (WOMAC, function tests) than a neoprene sleeve.(Silver) Based on 3 orthoses studies, of which 2 were high quality, (n=2) we conclude there is limited evidence that: a laterally wedged insole decreases NSAID intake compared with a neutral insole. (Silver) patient compliance is better in the laterally wedged insole compared with a neutral insole. (Silver) a strapped insole has more adverse effects than a lateral wedge insole. (Silver).