Qigong Exercise May Benefit Patients With Fibromyalgia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University of Kansas.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Wen Liu, Ph.D., University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01333566
First received: April 8, 2011
Last updated: June 4, 2012
Last verified: June 2012
  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

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • To investigate the effect of qigong exercise on pain [ Time Frame: up to 3months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01333566

Contacts
Contact: Wen Liu, PhD 913-588-4565 wliu@kumc.edu

Locations
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         
Sponsors and Collaborators
Wen Liu, Ph.D.
Investigators
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 August 20, 2014