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Osteoarthritis - Boston MA (Clinical Trial # 15512)

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City: Boston
State: MA
Zip Code: 02111
Study summary: Osteoarthritis (OA) causes pain and long-term disability, and the public health impact will increase as the population ages. In addition to inconsistent effectiveness, current treatments such as nonsteroidal anti-inflammatory drugs, knee replacement, and physical therapy may be expensive, resulting in serious adverse effects, reducing physical function, and failing to improve mental well-being. Finding effective treatments to maintain function and quality of life in OA patients is one of the national priorities identified this year by the Institute of Medicine.

We propose to conduct the first comparative effectiveness and cost-effectiveness trial of Tai Chi vs. physical therapy (PT) in a large symptomatic Knee OA population. A single-blind, randomized, controlled trial of Tai Chi vs. Physical Therapy will be conducted in 180 patients who meet the American College of Rheumatology criteria for Knee OA. Patients will be randomized to 12 weeks of treatment with Tai Chi (2x/week) or Standard Physical Therapy (2x/week for 6 weeks, followed by 6 weeks of rigorous supervised home exercise) with 24 and 52 week follow-ups.
Qualified participants must: • Be at least 40 years of age
• Have experienced pain on more than half the days of the past month during at least one of the following activities: walking, going up or down stairs, standing upright, or lying in bed at night
• Agree to an X-ray confirming osteoarthritis of the knee (provided free of charge)
• Agree to a clinical examination confirming knee pain or discomfort or instability referable to the knee joint
• Be physically able to participate in both the Tai Chi and Physical Therapy programs
• Be willing to undergo testing and intervention procedures and willing to abstain from Tai Chi until completion of the program, if randomized to Physical Therapy and willing to abstain from Physical Therapy until completion of the program, if randomized to Tai Chi
Participants may receive: Up to $200 in compensation and physical therapy or Tai Chi sessions at no cost.
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Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials or take the Participation Quiz to find out if you are a good candidate for clinical trial participation.


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