Multisite RCT Investigating the Efficacy of Massage in Osteoarthritis

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DESCRIPTION (provided by applicant): Osteoarthritis (OA), the most common form of arthritis, is a slowly progressive degenerative disease of joint cartilage that afflicts 40 million Americans. Existing pharmacologic therapies (acetaminophen, non- steroidal anti-inflammatories (NSAIDs), & COX-II inhibitors) can help to control pain, but their use is often limited by toxicity, and they often fail to fully alleviate symptoms. Massage therapy and other complementary and alternative medication (CAM) interventions, are being utilized by OA sufferers and represent attractive, potentially effective alternatives. Swedish massage, generally used to relieve pain for musculoskeletal conditions, has a high safety, low adverse event profile when administered by trained massage therapists. In 2004, UMDNJ-SHRP & the Yale-Griffin Prevention Research Center conducted a CDC-supported pilot trial of massage therapy for OA of the knee. That study, published in Archives of Internal Medicine in 2006, randomized 68 subjects to massage intervention or wait-listed control and demonstrated efficacy of Swedish massage therapy in the treatment of OA of the knee, with benefits persisting 8 weeks beyond treatment. This application is to conduct a follow-up, controlled trial to determine conclusively the therapeutic efficacy of this treatment. Proposed is a multi-site randomized wait-list controlled trial (n=170), informed by an initial dose- finding phase, to determine the utility of massage for OA of the knee. The main objective is to identify and evaluate a suitable dose of massage for therapeutic efficacy as a treatment for OA of the knee. The hypothesis is that a standardized dose of Swedish massage therapy over an 8-week period will lead to clinically significant improvement in intervention vs control subjects with OA of the knee as assessed by the Western Ontario & McMaster Universities OA Index (WOMAC), a validated self- administered tool to assess pain, stiffness and function. Secondary Aims include: 1) A dose-finding phase of 4 different regimens (n=80 total) of 8 weeks of Swedish massage in OA patients to determine the most suitable dose for thorough evaluation; 2) Determine the safety profile of 8 weeks of massage therapy; 3) Identify clinically significant improvements in other surrogate outcomes as a result of Swedish massage; 4) Assess the duration of therapeutic effects of massage; 5) Investigate the mechanism of action of massage for OA the knee through the quantitation of inflammatory cytokines, type II collagen breakdown & synthesis biomarkers, high sensitivity C-Reactive Protein and an anti-stress & anti-inflammatory hormone (DHEA-S); and 6) Measure resource utilization and direct medical, direct non-medical and productivity costs associated with OA management and the massage intervention. The proposed trial will establish the proper place for massage therapy among treatment options for OA sufferers. PUBLIC HEALTH RELEVANCE: Osteoarthritis (OA), the most common form of arthritis, is a slowly progressive, debilitating degenerative disease of joint cartilage that afflicts 30 million Americans. Conventional therapies for OA often fail to eliminate symptoms fully and have potential toxicities, which has necessitated the need to explore additional treatments. This study is being conducted to ascertain the utility of massage therapy as a treatment for patients afflicted with pain and disability secondary to OA of the knee and therefore may lead to a lessening of suffering for millions of individuals world-wide.