Qigong Exercise May Benefit Patients With Fibromyalgia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- To investigate the effect of qigong exercise on pain
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- 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).
Arms & Interventions
Control Group
Intervention: Placebo Comparator: Control Group (Behavioral)
Intervention Group
Intervention: Intervention Group (Behavioral)
Outcomes
Primary Outcomes
To investigate the effect of qigong exercise on pain
Time Frame: up to 3months
Secondary Outcomes
- To investigate the effect of qigong exercise on sleep quality(up to 3 months)
- To investigate the effect of qigong exercise on fatigue(up to 3 months)
- To investigate the effect of qigong exercise the quality of life in FM patients.(up to 3 months)