Qigong Exercise May Benefit Patients With Fibromyalgia
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Purpose
The long-term goal of our research program is to develop an effective and cost-saving mind-body therapy to help patients with FM. The objective of this pilot study is to gather pilot data of the effect on pain, fatigue, sleep quality, and quality of life in FM patients using a specific type of qigong exercise, i.e. "six healing sound" qigong. Changes in relevant brain activity will be monitored in study subjects before and after the qigong exercise program, which may help us in better understanding the underlying mechanism of the qigong exercise. Data collected in this pilot study will help the investigators in preparation for a future clinical trial with a larger sample size. Our central hypothesis for the future clinical trial is that qigong exercise will lead to a significantly greater improvement in pain, fatigue, sleep quality, and quality of life in the experimental group compared to the control group.
| Condition | Intervention |
|---|---|
|
Fibromyalgia |
Behavioral: Intervention Group Behavioral: Placebo Comparator: Control Group |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Qigong Exercise May Benefit Patients With Fibromyalgia |
- To investigate the effect of qigong exercise on pain [ Time Frame: up to 3months ] [ Designated as safety issue: No ]
- To investigate the effect of qigong exercise on fatigue [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
- To investigate the effect of qigong exercise on sleep quality [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
- To investigate the effect of qigong exercise the quality of life in FM patients. [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Intervention Group |
Behavioral: Intervention Group
The study will include one week baseline phase, 6-week intervention phase, and a 3-month follow-up evaluation. Subjects in the intervention group will go through three training sessions during the baseline phase, weekly group exercise sessions once per week and daily home exercises two times each day during the intervention phase, and a follow-up evaluation in three months after the intervention phase.
|
| Placebo Comparator: Control Group |
Behavioral: Placebo Comparator: Control Group
Subjects in the control group will be monitored during the baseline and intervention phase without participating in the interventional exercise. At the end of intervention phase, the subjects will have the option to stop their participation or switch to the intervention group.
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with a diagnosis of primary FM, based on the 1990 American College of Rheumatology criteria (Wolfe et al, 1990),
- between the ages of 18 and 70 years;
- willing to withdraw from CNS-active therapies commonly used to treat FM; willing to discontinue treatment with transcutaneous electrical nerve stimulation, biofeedback, tender- and trigger-point injections, acupuncture, and anesthetic or narcotic patches;
- with a raw score > 4 on the physical function component of the Fibromyalgia Impact Questionnaire (FIQ) (Burckhardt et al, 1991);
- and a mean visual analog scale (VAS) pain score > 40 on a scale from 0 to 100.
Exclusion Criteria:
- severe psychiatric illness;
- a current major depressive episode (as determined by a Beck Depression Inventory (Beck et al, 1961) score >25);
- significant suicide risk;
- abuse of alcohol, benzodiazepines, or other drugs; a history of behavior that would prohibit compliance for the duration of the study;
- active cardiovascular, pulmonary, hepatic, renal, gastrointestinal, or autoimmune disease (except Hashimoto's or Graves' disease that had been stable for 3 months before screening);
- current systemic infection; active cancer (except basal cell carcinoma); unstable endocrine disease; severe sleep apnea;
- prostate enlargement or other genitourinary disorder (male patients);
- or pregnancy or breastfeeding (female patients).
Contacts and Locations| Contact: Wen Liu, PhD | 913-588-4565 | wliu@kumc.edu |
| United States, Kansas | |
| University Of Kansas Medical Center | Recruiting |
| Kansas City, Kansas, United States, 66160 | |
| Contact: Wen Liu, PhD 913-588-4565 wliu@kumc.edu | |
| Principal Investigator: Wen Liu, PhD | |
| Principal Investigator: | Wen Liu, PhD | University of Kansas |
More Information
No publications provided
| Responsible Party: | Wen Liu, Ph.D., Associate Professor, University of Kansas Medical Center Research Institute |
| ClinicalTrials.gov Identifier: | NCT01333566 History of Changes |
| Other Study ID Numbers: | 11889 |
| Study First Received: | April 8, 2011 |
| Last Updated: | June 4, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases |
Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013