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Tai Chi Mind-Body Therapy for Knee Osteoarthritis
This study is ongoing, but not recruiting participants.
First Received: August 9, 2006   Last Updated: March 26, 2008   History of Changes
Sponsored by: National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier: NCT00362453
  Purpose

The purpose of this study is to compare the safety and effectiveness of Tai Chi with a stretching and wellness education program in 40 patients with OA of the knee.


Condition Intervention
Knee Osteoarthritis
Behavioral: 12-week tai Chi program
Behavioral: 12-week stretching and wellness education program

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Tai Chi Mind-Body Therapy for Knee Osteoarthritis: a Pilot Single-Blind Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:
  • Knee symptoms (WOMAC questionnaire)

Secondary Outcome Measures:
  • Physical function, clinical knee examination, knee joint proprioception, health related quality of life, outcome expectation measure, occurrence of adverse events, and adherence.

Estimated Enrollment: 40
Study Start Date: August 2005
Estimated Study Completion Date: March 2008
Detailed Description:

Osteoarthritis (OA) is the most common form of arthritis in the United States, affecting 21 million older people.

Symptomatic knee OA in the elderly is one of the most frequent causes of loss of independence and physical disability. There are currently no satisfactory pharmacological or non-pharmacological therapies for knee OA. New strategies to improve functional capacity, quality of life and reduce long-term disability in people with knee OA are urgently needed. Our long-term goal is to demonstrate the physical and psychological benefits of Tai Chi exercise as a complementary treatment for people with knee OA. Tai Chi is a traditional Chinese discipline with both physical and mental components that appear to benefit a variety of conditions. The physical component provides exercise that is consistent with recommendations for OA (range of motion, flexibility, muscle conditioning and aerobic cardiovascular exercise), while the mental component has the potential to increase psychological well-being, life satisfaction, and perceptions of health. These effects are especially pertinent for the treatment of older adults with knee OA.

Over a three-year period, 40 patients with symptomatic knee OA will be randomly assigned to receive a 12-week Tai Chi program or stretching and wellness education program. Each participant will be in the study for 1 year. Outcome measurements will be obtained at baseline and on completion of the 12-week program, as well as 3 month and 6 month follow-up period. We will compare changes in knee pain, stiffness, and physical function using the well-validated Western Ontario and McMaster University Index, as well as clinical knee examination, lower extremity functional, knee joint proprioception, and health related quality of life.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • · Age 55 or older

    • Body Mass Index (BMI) <= 40 kg/m
    • 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 in bed at night)105
    • Radiographic evidence of knee OA, defined as the presence of Osteophytes in the tibiofemoral compartment and

      • or the patellofemoral compartment, as assessed on standing anterior/posterior and lateral views
    • WOMAC pain subscale score, at least 1 of 5 (range 0 to 100 each) >= 40 (visual analog version)
    • Physically able to participate in both the Tai Chi and stretching and education programs
    • Willing to complete the 12-week study, including twice-a-week Tai Chi or stretching and education sessions
    • Willing to abstain from Tai Chi until completion of the program, if randomized to the stretching and education sessions
    • Willing to abstain from stretching and education sessions until completion of the program, if randomized to Tai Chi

Exclusion Criteria:

  • Prior experience with Tai Chi or other similar types of Complementary and Alternative Medicine such as Qi gong, yoga, and acupuncture since these share some of the principles of Tai Chi
  • Dementia, neurological disease, cardiovascular disease, pulmonary disease, metabolic disease, renal disease, liver disease, or other serious medical conditions limiting ability to participate in either the Tai Chi or stretching programs as determined by primary care physicians
  • Any intra-articular steroid injections in the previous 3 months or reconstructive surgery on the affected knee
  • Any intra-articular Synvisc or Hyalgan injections in the previous 6 months
  • Inability to pass the Mini-Mental Status examination (with a score below 24)
  • Enrollment in any other clinical trial within the last 30 days
  • Plan to permanently relocate from the region during the trial period
  • Non English Speaking
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00362453

Locations
United States, Massachusetts
Tufts-New England Medical Center, Division of Rheumatology
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Investigators
Principal Investigator: Chenchen Wang, MD Tufts Medical Center
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Study ID Numbers: R21 AT002161
Study First Received: August 9, 2006
Last Updated: March 26, 2008
ClinicalTrials.gov Identifier: NCT00362453     History of Changes
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Osteoarthritis, Knee
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases

Additional relevant MeSH terms:
Osteoarthritis, Knee
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 02, 2009