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Abstract
Grant Number: 5R21AT001352-02 Project Title: Qigong Therapy for Osteoarthritis at Knees
PI Information: Name Title CHEN, KEVIN W. kchen@compmed.umm.edu Abstract: DESCRIPTION (provided by applicant): This dual-blinded randomized trial with placebo control investigates the clinical effectiveness of external Qigong therapy (EQT) for pain relief and symptom improvement in patients with osteoarthritis (OA) at the knees. Arthritis is the leading cause of disability in America. Current pharmacological therapies for OA are effective to various degrees in controlling symptoms with significant drawbacks like cost, toxicity and other potential detrimental effects. Qigong therapy might be an effective non-pharmacological treatment for arthritis with less cost and no side effect. The specific aims include: (1) to investigate the effectiveness of external qigong therapy for treating osteoarthritis; (2) to examine the short-term and long-term ability of Qigong therapy to decrease negative mood such as anxiety or depression among arthritis patients; and (3) to test suggestibility as a predictor of pain reduction and whether it modifies the effect of Qigong treatment, such that the treatment might be less effective among less suggestible subjects. These aims will be achieved through a controlled clinical trial of 70 patients with OA at knees, and randomly assign them into either the qigong or the sham treated group. Qigong treatment consists of "qi emission" by the therapist toward the affected joint area for 5-10 minutes in each session, for a total of 5 sessions within 2 weeks. A follow-up 3 months after the treatment is planned to evaluate the long-term effectiveness. The measures of efficacy will be primarily by WOMAC OA index, which includes three subscales for pain, stiffness and physical difficulty, as wells as the McGill Pain Questionnaire (SF), Spielberger Anxiety Scale, Beckman Depression Inventory, Lorig's self-efficacy scale, and swollen/tender joint count. In addition, a history of average daily NSAID and analgesics dosages and other CAM therapies at the baseline and throughout the intervention will be monitored to assess possible changes after the treatment. Differences in the degree of improvement between the treatment groups will be assessed with Student t test. The mixed effect model and MANOVA with repeated measures will be used to examine changes in degree of pain, stiffness, physical difficulty and anxiety, with control for demographics, pain history, drug dosage and other potential confounders. The proposed trial of EQT is not a definitive study of the therapy but a proof of principle. This pilot trial should provide a foundation for a more systematic exploration of the benefits of qigong exercise (self-practice) and EQT in reducing or eliminating chronic arthritis pain.
Public Health Relevance:
This Public Health Relevance is not available.Thesaurus Terms:
alternative medicine, arthritis therapy, behavior prediction, human therapy evaluation, osteoarthritis
anxiety, chronic pain, clinical trial, depression, functional ability, knee, suggestion
behavioral /social science research tag, clinical research, human subject, patient oriented research, questionnaire
Institution: UNIV OF MED/DENT NJ-R W JOHNSON MED SCH ROBERT WOOD JOHNSON MEDICAL SCH PISCATAWAY, NJ 088548021 Fiscal Year: 2005 Department: Psychiatry Project Start: 15-SEP-2004 Project End: 30-SEP-2006 ICD: NATIONAL CENTER FOR COMPLEMENTARY & ALTERNATIVE MEDICINE IRG: ZAT1