Back to resultsQigong Exercise May Benefit Patients With Fibromyalgia
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention Group
Placebo Comparator: Control Group
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia
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).
Sites / Locations
- University Of Kansas Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intervention Group
Control Group
Arm Description
Outcomes
Primary Outcome Measures
To investigate the effect of qigong exercise on pain
Secondary Outcome Measures
To investigate the effect of qigong exercise on fatigue
To investigate the effect of qigong exercise on sleep quality
To investigate the effect of qigong exercise the quality of life in FM patients.
Full Information
NCT ID
NCT01333566
First Posted
April 8, 2011
Last Updated
July 1, 2016
Sponsor
University of Kansas Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01333566
Brief Title
Qigong Exercise May Benefit Patients With Fibromyalgia
Official Title
Qigong Exercise May Benefit Patients With Fibromyalgia
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Title
Control Group
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Intervention Group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Placebo Comparator: Control Group
Intervention Description
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 Outcome Measure Information:
Title
To investigate the effect of qigong exercise on pain
Time Frame
up to 3months
Secondary Outcome Measure Information:
Title
To investigate the effect of qigong exercise on fatigue
Time Frame
up to 3 months
Title
To investigate the effect of qigong exercise on sleep quality
Time Frame
up to 3 months
Title
To investigate the effect of qigong exercise the quality of life in FM patients.
Time Frame
up to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen Liu, PhD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
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Qigong Exercise May Benefit Patients With Fibromyalgia
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