FibromyalgiaNCT01333566
Qigong Exercise May Benefit Patients With Fibromyalgia
A study testing Intervention Group in people with Fibromyalgia, run by University of Kansas Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University Of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
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.
- Conditions
- Fibromyalgia
- Being tested
- Intervention Group, Placebo Comparator: Control Group
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupBehavioural
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 GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Not described Receives: Behavioral: Intervention Group |
| Control Group | Placebo comparator | Not described Receives: Behavioral: Placebo Comparator: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the effect of qigong exercise on pain
Measured: up to 3months
Secondary outcomes (3)
To investigate the effect of qigong exercise on fatigue
Measured: up to 3 months
To investigate the effect of qigong exercise on sleep quality
Measured: up to 3 months
To investigate the effect of qigong exercise the quality of life in FM patients.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2011 (estimated)
- Study startJul 2009
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wen Liu, PhD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01333566
- Sponsor's protocol ID
- 11889
- Status last verified
- Jul 2016
- First submitted
- 8 Apr 2011
- Last updated
- 4 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qigong Exercise May Benefit Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT01333566
- Acronym / sponsor ID
- 11889
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 12 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Intervention Group |
| Control Group | Placebo comparator | Behavioral: Placebo Comparator: Control Group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention GroupThe 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. | Behavioural | Intervention Group |
| Placebo Comparator: Control GroupSubjects 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. | Behavioural | Control Group |
Primary outcome
To investigate the effect of qigong exercise on pain
Time frame: up to 3months
3 secondary outcomes
To investigate the effect of qigong exercise on fatigue
Time frame: up to 3 months
To investigate the effect of qigong exercise on sleep quality
Time frame: up to 3 months
To investigate the effect of qigong exercise the quality of life in FM patients.
Time frame: up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wen Liu, PhD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Fibromyalgia, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To investigate the effect of qigong exercise on pain (time frame: up to 3months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2016; AzTrials last refreshed its copy on 6 Nov 2026.