MULTISITE RCT INVESTIGATING THE EFFICACY OF MASSAGE IN OSTEOARTHRITIS

Duke University, Durham NC

Investigators

Linked publications, trials & patents

Abstract

DESCRIPTION (provided by applicant): Osteoarthritis (OA) is a slowly progressive degenerative disease of the joints that afflicts approximately 27 million Americans. Already the most frequently reported chronic condition in the elderly, OA is projected to affect more than 67 million Americans by 2030. Conventional therapies for OA are incompletely effective and at times impose serious side effects, leaving many facing surgery or chronic, often debilitating, pain, muscle weakness, lack of stamina, and loss of function. OA of the hip or knee is particularly disabling because it limits ambulation. In a 2004 pilot RCT of massage therapy for osteoarthritis (OA) of the knee (CDC SIP-14-00), we demonstrated the feasibility, safety, and apparent efficacy of Swedish massage, with benefits of increased function and decreased pain persisting eight weeks following treatment cessation. A Phase 2 dose-finding study (NIH/NCCAM R01AT004623) to determine the optimal dose and frequency of Swedish massage for the treatment of OA of the knee is near completion. Proposed is the next step in this line of inquiry: a blinded, dual-site RCT to verify the efficacy of the optimal dose of manualized massage, assess the utility of maintenance dosing, and gather data to support subsequent cost-effectiveness analysis. This study will utilize a practical 'optimal' dose of massage determined by our Phase 2 study. The proposed study utilizes several novel approaches: 1) a nonpharmacological intervention defined by a formal dose-finding trial, 2) incorporation of a manualized massage intervention with demonstrated feasibility and clinical response, 3) the use of both active and passive controls for massage therapy, and 4) the investigation of the durability of the intervention over a one-year period, as well as the utility of maintenance dosing. We aim to: 1) Verify the efficacy of an 8-week course of Swedish massage, at an optimized dose, for reducing pain and increasing function compared to an active (light touch) control and passive (usual care) control in 219 adults with OA of the knee 2) Assess the duration of therapeutic effect of 8 weeks of Swedish massage, and 3) Assess the utility of maintenance doses of massage or light-touch bodywork. 4) Collect cost and utilization data to subtend a formal, cost-effectiveness analysis. This study by an experienced team of collaborators is an integral step in a line of inquiry with the potential to change clinical practice. Demonstrating massage to be a valuable and viable treatment option, and laying the foundation to establish it as a reimbursable one, constitutes a highly significant innovation for the standard clinical management of OA.