The purpose of this study is to evaluate the effectiveness of Qigong therapy, an ancient Chinese practice, for pain relief and symptom improvement in people with knee osteoarthritis (OA).

Study hypotheses: 1) Qigong therapy will result in greater reduction of pain and greater symptom improvement than sham treatment. 2) Individuals with a history of complementary and alternative medicine (CAM) use will be more likely to experience benefits of Qigong therapy than those without such experience.

Condition	Treatment or Intervention
Osteoarthritis	Procedure: External Qigong therapy

Further Study Details: 

Primary Outcomes: Pain, stiffness, and physical function scale results
Secondary Outcomes: McGill Pain Questionnaire (MPQ-SF) results; Spielberger State-Trait Anxiety Scale (STAI) results; Daily dosage of drugs for pain relief; Range of motion for knees; Time to walk 50 feet
Expected Total Enrollment:  100

OA is the leading cause of disability in the United States. Standard treatment for OA is drug therapy; however, cost, side effects, and varying levels of effectiveness warrant the need for development of new treatments. Qigong therapy, which involves deep meditation, breathing exercises, and the harnessing of energy, may be an effective treatment for OA.

According to traditional Chinese medicine, Qi (Chi) is the "life force" that flows through the body and keeps people healthy and vital. In the practice of traditional Chinese medicine, arthritis is thought to be due to a blockage of the flow of Qi or a buildup of abnormal or damaging Qi. It is believed that releasing this buildup or breaking the blockage of Qi through Qigong therapy may relieve OA symptoms.

Participants will be randomly assigned to receive five sessions of either Qigong therapy or sham treatment over a period of 2 weeks. During Qigong therapy, a therapist will send his or her Qi to the arthritic knees through touch and meditation. Similar body work will be performed during the sham treatment, but no Qi will be harnessed. Self-report scales that measure pain, stiffness, anxiety, daily drug use, CAM use, and overall functioning will be used to assess participants. The assessments will occur at study start and at a 3-month follow-up visit.

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Diagnosis of osteoarthritis at least 6 months prior to study entry
• Able to understand English

Exclusion Criteria:

• Inflammatory joint disease affecting leg movement
• Knee replacement surgery on the OA knee
• Depo-corticosteroids knee injections within 3 months prior to study entry
• Pain in hips or lower back affecting leg movement
• New arthritis drugs or other painkillers within 2 weeks prior to study entry
• Investigational drugs within 30 days prior to study entry
• Asthma requiring oral corticosteroids within 4 weeks prior to study entry

Joy Staller, BA      732-235-3453    stalleje@umdnj.edu

New Jersey
      University of Medicine and Dentistry, New Jersey-Robert Wood Johnson Medical School, Piscataway,  New Jersey,  08854,  United States; Recruiting
      University of Medicine and Dentistry, New Jersey-Robert Wood Johnson Medical School, Newark,  New Jersey,  07103,  United States; Recruiting

Study chairs or principal investigators

Kevin W. Chen, PhD MPH,  Principal Investigator,  Division of Addiction Psychiatry, University of Medicine and Dentistry, New Jersey-Robert Wood Johnson Medical School   
Leonard Sigal, MD,  Principal Investigator,  Rheumatology Department - Biomedical Sciences Program, University of Medicine and Dentistry, New Jersey-Robert Wood Johnson Medical School   

Study ID Numbers:  R21-AT001352-01A2
Record last reviewed:  February 2005
Last Updated:  February 25, 2005
Record first received:  February 23, 2005
ClinicalTrials.gov Identifier:  NCT00104156
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08