More than 450 adult patients with symptomatic knee osteoarthritis were enrolled in a multicenter randomized trial evaluating compartment-specific knee bracing and patient-reported outcomes.
In the multicenter, parallel group, superiority study, researchers found that adding compartment-specific knee bracing with an adherence intervention to advice, written information, and exercise instruction resulted in greater improvement in the Knee Osteoarthritis Outcomes Score five-item composite at 6 months compared with usual nonpharmacologic care alone. They noted an adjusted mean difference of 3.39 points on a 0 to 100 scale between those who did and didn't receive knee bracing and a small effect size of 0.24. Improvements were also observed at 3 months and were attenuated by 12 months, when between-group differences were no longer statistically significant.
The study was conducted across four regions in England. The researchers enrolled 466 adult patients aged 45 years or older with clinically assessed knee osteoarthritis (OA) and moderate to severe pain during weight-bearing activity. The participants were randomly assigned in a 1:1 ratio to receive either advice, written information, and exercise instruction alone or the same intervention plus compartment-specific knee bracing. Randomization was stratified by site, predominant compartmental distribution of OA, and knee instability, and the trial statistician was blinded to treatment allocation.
The control intervention consisted of a single in-person consultation with a trained physiotherapist that included education on knee OA, self-management advice, written materials, and instruction in a home-based lower limb exercise program. The participants in the intervention group received the same care but also were fitted for a patellofemoral, tibiofemoral unloading, or neutral stabilizing knee brace informed by clinical and radiographic assessment. Additional components included a follow-up consultation at 2 weeks and adherence support delivered through brief motivational interviewing and automated text message prompts over 6 months. The participants were advised to wear the brace during painful weight-bearing activities, with duration increased gradually according to tolerance.
Secondary analyses indicated that treatment effects were driven primarily by reductions in pain and improvements in activities of daily living. At 6 months, the bracing group had greater improvement on the Knee Osteoarthritis Outcomes Score pain subscale, with an adjusted mean difference of 6.13 points, and reported lower pain during weight-bearing activity, with a mean reduction of 0.80 points on a 0 to 10 scale. The benefits were generally larger at 3 and 6 months compared with at 12 months. Adherence to brace use declined over time, although the participants meeting predefined adherence criteria experienced greater improvements. Adverse events were common but expected and mild, most frequently skin irritation or redness, and no unexpected serious adverse reactions were reported.
The researchers identified several limitations. For instance, the participants and physiotherapists couldn't be blinded to treatment allocation, and some outcome data were collected by unblinded staff because of COVID-19 pandemic–related disruptions. The intervention group received more physiotherapist contact time compared with the control group, raising the possibility of contextual effects. Brace adherence decreased over the follow-up period, and some participants in the control group reported using a knee brace, potentially diluting between-group differences. The study population was predominantly White, with limited representation from more socioeconomically deprived groups, which may limit generalizability. Additionally, because the intervention combined bracing with multiple adherence-support strategies, the relative contribution of individual components couldn't be determined.
Disclosures can be found in the study.
Source: The BMJ