View Clinical Trial (Medical Research Study)
Qigong Exercise May Benefit Patients With Fibromyalgia
| City: |
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Kansas City |
| State: |
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Kansas |
| Zip Code: |
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66160 |
| Conditions: |
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Fibromyalgia |
| Purpose: |
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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.
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| Study Summary: |
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| Criteria: |
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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).
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| NCT ID: |
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NCT01333566 |
| Primary Contact: |
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Principal Investigator
Wen Liu, PhD
University of Kansas
Wen Liu, PhD
Phone: 913-588-4565
Email: wliu@kumc.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Kansas City, Kansas 66160
United States
Wen Liu, PhD
Phone: 913-588-4565
Email: wliu@kumc.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
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