Clinical trial NCT01333566: Qigong Exercise May Benefit Patients With Fibromyalgia
Official title: Qigong Exercise May Benefit Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2011-04-12
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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).

Primary outcomes:
measure: To investigate the effect of qigong exercise on pain
timeFrame: up to 3months
Secondary outcomes:
measure: To investigate the effect of qigong exercise on fatigue
timeFrame: up to 3 months
measure: To investigate the effect of qigong exercise on sleep quality
timeFrame: up to 3 months
measure: To investigate the effect of qigong exercise the quality of life in FM patients.
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University Of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Wen Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References: