Bracing the Patellofemoral Osteoarthritis: A Clinical Trial

Boston University Medical Campus, Boston MA

Investigators

Linked publications & trials

Abstract

Osteoarthritis (OA) is a significant public health challenge, being ranked as the leading cause of disability[unreadable] in elders. Relatively little heed has been paid to studying or treating the patellofemoral (PF) joint in OA,[unreadable] despite suggestions that disease there may be strongly correlated with lower extremity disability.[unreadable] The specific aims of this proposal are:[unreadable] 1) To undertake a 20 week randomized crossover clinical trial in patients with patellofemoral[unreadable] osteoarthritis to determine whether provision of patellofemoral bracing leads to lower pain scores and[unreadable] improved function during the time of this treatment than during the use of a placebo treatment;[unreadable] 2) To perform an open label follow-up study to track use and effectiveness of treatment.[unreadable] We propose a double blind, randomized crossover trial of a patellofemoral bracing for patients with[unreadable] patellofemoral osteoarthritis with the primary outcome being knee pain as assessed by the VAS scale on[unreadable] movement, and pain during an aggravating activity nominated by the participant. The two treatments will be[unreadable] as follows: TREATMENT A (CONTROL), a neutral brace without the donut (buttress) and realigning strap[unreadable] and TREATMENT B (ACTIVE), a patellofemoral brace (DonJoy Tru-pull advanced).[unreadable] A run-in design will be used to maximize the likelihood of recruiting subjects who will remain in the trial.[unreadable] Subjects will be randomized to treatment A or B for 6 weeks, with an 8 week washout. For each subject, the[unreadable] trial will last 20 weeks. Study evaluation will take place at the Boston University Medical Center GCRC. The[unreadable] subject's will then be followed for 6 months in an open-label follow-up.[unreadable] Recent estimates suggest that symptomatic knee OA occurs in 13% of persons age 60 and over. There has[unreadable] been a remarkable neglect of physical treatment modalities that is, in part, a consequence of drug[unreadable] development opportunities. The need to develop treatment approaches that are capable of ameliorating the[unreadable] symptoms of OA is an important research objective. This project constitutes an attempt to test a promising[unreadable] physical treatment modality. The short-term outcomes of this project will be to assess the efficacy of knee[unreadable] bracing for pain and disability in patellofemoral osteoarthritis. The longer-term outcome of demonstrating[unreadable] efficacy of such an intervention will be to reduce pain and disability arising from patellofemoral osteoarthritis[unreadable] in the wider community.[unreadable]