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Completed

NCT Number: NCT01333566

Qigong Exercise May Benefit Patients With Fibromyalgia

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Intervention Group

Behavioral

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

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.

Primary outcomes

  1. To investigate the effect of qigong exercise on pain

    Time frame: up to 3months

Secondary outcomes

  1. To investigate the effect of qigong exercise on fatigue

    Time frame: up to 3 months

  2. To investigate the effect of qigong exercise on sleep quality

    Time frame: up to 3 months

  3. To investigate the effect of qigong exercise the quality of life in FM patients.

    Time frame: up to 3 months

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Apr 12, 2011
Registry last updated
Jul 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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