Massage Therapy for Osteoarthritis of the Knee
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 66
- Locations
- 2
- Primary Endpoint
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and functional scores
Study Overview
Brief Summary
The study is a randomized, controlled clinical trial that investigates the efficacy ogf massage therapy for 66 patients with pain secondary to osteoarthritis of the knee. It is a wait-list design where subjects and randomly assigned to either Group A or Group B. Group A receives two months of massage while Group B is wait-listed, receives two months of usual care. At the conclusion of the wait period, Group B receives two months of massage. In all cases, subjects continue to receive conventional medical care for their OA symptoms.
Outcome measures include a WOMAC questionnaire, a visual analog pain scale, time to walk fifty feet and range of motion of the knee (using a goniometer). A research assistant, competent in appropriate subject assessment obtains the outcome measures. Change in medication use is tracked by the use of patient diaries. Assessments of subjects, occurs at baseline, and week 8 and 16 in both the intervention and control groups.
Detailed Description
The Yale-Griffin Prevention Research Center has received funding from the Centers for Disease Control and Prevention to conduct the Complementary and Alternative Medicine (CAM) Outcomes Research Project (CORP). CORP includes a systematic review of the CAM literature and the development of pilot studies assessing selected CAM interventions. The first year efforts of the CORP research team have culminated in the selection of pilot studies involving three public health priority conditions (attention deficit hyperactivity disorder, asthma, and osteoarthritis) and common CAM interventions. A pilot study investigating the effects of a massage therapy intervention for osteoarthritis is detailed in this application.
Osteoarthritis (OA), the most common form of arthritis, is a slowly progressive degenerative disease of joint cartilage that afflicts 30 million Americans (Praemer A, Furner S, Rice D. Musculoskeletal Conditions in the United States, p 40: American Academy of Orthopaedic Surgeons, 1992). It becomes more prevalent with advancing age (Peyron JG. Osteoarthritis: The Epidemiologic ViewPoint. Clin Orthop, 213:13-19, 1986). Nearly half of America's elderly suffer from osteoarthritis, and arthritis is the most frequently reported chronic condition in the elderly (Praemer A, Furner S, Rice D. Musculoskeletal Conditions in the United States, p 36: American Academy of Orthopaedic Surgeons, 1992).
Osteoarthritis affects approximately 3 out of every 100 Americans below age 45 and more than a quarter of Americans between the ages of 45 and 64 suffer from this disabling disease (National Center for Health Statistics. Current Estimates from the National Health Interview Survey, 1988; Vital and Health Statistics. Series 10: No. 173, DHHS Pub. No. (PHS) 89-1501. Public Health Service, Hyattsville, MD, Oct. 1989; Kelsey JL, Hochberg MC. Epidemiology of Chronic Musculoskeletal Disorders. Am Rev Public Health, 91:379-401, 1988).
Osteoarthritis of the hip or knee is particularly disabling because it limits ambulation, but the affliction also strikes the hands, the spine, and the feet with the same destructive joint process (Felson DT. Epidemiology of Osteoarthritis: Prevalence and Risk Factors. Osteoarthritis Disorders, American Academy of Orthopaedic Surgeons, 1995). The endpoint of the OA disease process is total loss of joint cartilage in the affected area and the need for joint replacement.
The high prevalence of arthritis in the population is reflected in the economic burden engendered to treat those afflicted. The total cost of conventional treatments for arthritis in 1988, for example, was estimated at 54.6 billion dollars (Lazenby HC, Letsch SW. National Health Expenditures 1989; Health Care Financing Review, 12(2):1-26, 1990). Conventional treatments for OA include pain medication (NSAIDS and cox-2 inhibitors), exercises, hot/cold therapy, steroid injections and, eventually, surgery to repair the joint (Felson DT. Epidemiology of Osteoarthritis: Prevalence and Risk Factors. Osteoarthritis Disorders, American Academy of Orthopaedic Surgeons, 1995). Despite conventional treatment, OA is a progressive disease that frequently leads to chronic pain and disability.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 35 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Radiographically confirmed diagnosis of osteoarthritis
- •35 years of age or greater
- •pre-randomization VAS score between 4 and 9
Exclusion Criteria
- •Rheumatoid, arthritis, fibromyalgia, recurrent or active pseudo-gout, cancer or other serious medical condition
- •History of kidney or liver failure
- •Asthma requiring steroids
- •oral steroids within the last four weeks
- •Intra-articular knee depo-corticosteroids within the previous 3 months
- •Intra-articular hyaluronate within the previous 6 months
- •Arthroscopy of the knee within the previous year
- •Significant injury to the knee within the previous 6 months
- •rash or open wound over the knee
Outcomes
Primary Outcomes
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and functional scores
Visual Analog Scale (VAS)
Secondary Outcomes
- Range of motion
- Time to walk 50 feet
