The Patella Pro study — effect of a knee brace on patellofemoral pain syndrome: design of a randomized clinical trial (DRKS-ID:DRKS00003291)

BACKGROUND: Patellofemoral pain syndrome (PFPS) is a frequent cause of anterior knee pain predominantly affecting young female patients who do not have significant chondral damage. Development of PFPS is probably multifactorial, involving various knee, hip, and foot kinematic factors. Biomechanical studies have described patellar maltracking and dynamic valgus (functional malalignment) in patients with patellofemoral pain syndrome. The literature provides evidence for short-term use of nonsteroidal anti-inflammatory drugs; short-term medially directed taping; and exercise programs focusing on the lower extremity, hip, and trunk muscles. Evidence supporting the use of patellar braces is limited because previous studies have been low quality. The aim of this article is to publish the design of a prospective randomized trial that examines the outcomes of patients with PFPS after treatment with a new patellar brace (Patella Pro) that applies medially directed force on the patella. METHODS/DESIGN: For this multicenter trial, 156 patients (adolescents and young adults) with PFPS were recruited from orthopedic practices and orthopedic hospitals and randomly allocated to 3 months of supervised physiotherapy in combination with the Patella Pro brace or supervised physiotherapy alone. The primary outcome measures are pain (numerical analog scale); knee function (Kujala score and Knee Injury and Osteoarthritis Outcome Score); and self-reported perception of recovery at baseline, 6 weeks, 3 months, and 1 year. DISCUSSION: Only limited evidence for the use of a patellar brace for the treatment of PFPS exists in the literature. Disputable evidence for the use of orthoses for PFPS patients has been presented in one meta-analysis, in which only one of three studies found the effect of a medially directed patellar brace to be significant. Because of these low-quality studies, the authors concluded that this evidence should be regarded as limited, and we feel there is a need for further well-designed studies to evaluate the effect of patellar bracing on PFPS-related pain. The Patella Pro study is a prospective randomized trial in which supervised physiotherapy in combination with a patellar brace is compared with supervised physiotherapy alone. This trial started in April 2012 and finished in October 2013. TRIAL REGISTRATION: DRKS-ID:DRKS00003291, January 3(rd), 2012