FibromyalgiaNCT00966732
Yoga for Fibromyalgia
A study testing Yoga of Awareness Program in people with Fibromyalgia, run by Oregon Health and Science University at 1 site in United States.
Trial summary
Fibromyalgia is a common, costly and debilitating illness which affects mostly women. Fibromyalgia patients report widespread musculoskeletal pain, fatigue, stiffness, and distress. Several consensus statements indicate that optimal care combines medication, exercise, and psychology. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Yoga of Awareness Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Dec 2010
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women ≥21 years of age
- diagnosed with fibromyalgia by ACR criteria for at least 1 year
- on a stable regimen of pharmacologic and/or non-pharmacologic treatment for FM ≥3 months
Who cannot join
- reside >70 miles from the research site
- unavailable to attend the intervention at one of the scheduled times
- currently engaged in intensive yoga practice (practice >3 days/wk)
- score >29 on the Beck depression scale modified for fibromyalgia
- currently undergoing disability application or involved in litigation
- elective surgery scheduled during the study period
- physically disabled in a manner that precludes meaningful participation in the intervention (eg, quadriplegic paralysis)
- do not speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Yoga of Awareness Program for Fibromyalgia: A Randomized Clinical Trial
Fibromyalgia is a common, costly and debilitating illness which affects mostly women. Fibromyalgia patients report widespread musculoskeletal pain, fatigue, stiffness, and distress. Several consensus statements indicate that optimal care combines medication, exercise, and psychology. Yoga is a popular mind/body discipline which holds promise for reducing fibromyalgia symptoms. The aim of this pilot study is to evaluate the effects of an innovative program, Yoga of Awareness, in which yoga poses are complemented by meditation and breathing exercises, presentations on healthy coping, and group discussions. Fifty-six women with fibromyalgia will be recruited and randomly divided into two groups. One group will receive the yoga program right away, and the other group will wait 3 months before receiving the program. Information about fibromyalgia symptoms and functioning will be collected from both groups before and immediately after the first group receives the yoga program. When results from the 2 groups are compared, the investigators expect patients who received the yoga program will have greater gains in fibromyalgia symptoms, physical function and pain coping capacities then those waiting to receive the program. If this study shows the yoga program is effective, the investigators will use this data in 2010 to apply to the National Institutes of Health for a more complete study of its benefits.
- Conditions
- Fibromyalgia
- Being tested
- Yoga of Awareness Program
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga of Awareness ProgramBehavioural
The 8 week yoga program will meet in groups of about 8-10 persons. Each 2-hour session will include gentle stretching, strengthening, and balance poses; meditation exercises; breathing techniques; study of pertinent topics (eg, mind/body stress reactivity), and group discussions (eg, experiences while practicing yoga). Participants will be asked to practice yoga methods at home, guided by a DVD (or audio recordings). The program will be taught by a certified yoga teacher (RYT) who has extensive experience in teaching yoga to medical patients.
| Study group | Role | What they receive |
|---|---|---|
| yoga condition | Experimental | assigned to start the yoga program right away Receives: Behavioral: Yoga of Awareness Program |
| wait-list control condition | No intervention | This condition will control for any effects of symptom measurement reactivity in patients receiving routine fibromyalgia medical care. After the 3-month assessment, the yoga intervention program will be provided to these patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibromyalgia Impact Questionnaire Revised (FIQR)
Measured: baseline, 3 months, 6 months
Secondary outcomes (3)
Vanderbilt Multidimensional Pain Coping Inventory (VMPCI)
Measured: baseline, 3 months, 6 months
Chronic Pain Acceptance Questionnaire (CPAQ)
Measured: baseline, 3 months, 6 months
Coping Strategies Questionnaire Catastrophizing Subscale (CSQCAT)
Measured: baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2009 (estimated)
- Study startOct 2009
- Primary completionDec 2010
- Study completionDec 2010
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.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James W Carson, PhD, Oregon Health and Science University
- Investigators
- James W Carson, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00966732
- Sponsor's protocol ID
- Yoga for Fibromyalgia
- Status last verified
- Oct 2014
- First submitted
- 26 Aug 2009
- Last updated
- 16 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga of Awareness Program for Fibromyalgia: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00966732
- Acronym / sponsor ID
- Yoga for Fibromyalgia
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 27 Aug 2009 (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.
Fibromyalgia is a common, costly and debilitating illness which affects mostly women. Fibromyalgia patients report widespread musculoskeletal pain, fatigue, stiffness, and distress. Several consensus statements indicate that optimal care combines medication, exercise, and psychology. Yoga is a popular mind/body discipline which holds promise for reducing fibromyalgia symptoms. The aim of this pilot study is to evaluate the effects of an innovative program, Yoga of Awareness, in which yoga poses are complemented by meditation and breathing exercises, presentations on healthy coping, and group discussions. Fifty-six women with fibromyalgia will be recruited and randomly divided into two groups. One group will receive the yoga program right away, and the other group will wait 3 months before receiving the program. Information about fibromyalgia symptoms and functioning will be collected from both groups before and immediately after the first group receives the yoga program. When results from the 2 groups are compared, the investigators expect patients who received the yoga program will have greater gains in fibromyalgia symptoms, physical function and pain coping capacities then those waiting to receive the program. If this study shows the yoga program is effective, the investigators will use this data in 2010 to apply to the National Institutes of Health for a more complete study of its benefits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| yoga condition | Experimental | Behavioral: Yoga of Awareness Programassigned to start the yoga program right away |
| wait-list control condition | No intervention | –This condition will control for any effects of symptom measurement reactivity in patients receiving routine fibromyalgia medical care. After the 3-month assessment, the yoga intervention program will be provided to these patients. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- women ≥21 years of age
- diagnosed with fibromyalgia by ACR criteria for at least 1 year
- on a stable regimen of pharmacologic and/or non-pharmacologic treatment for FM ≥3 months
Key exclusion criteria (8 listed)
- reside >70 miles from the research site
- unavailable to attend the intervention at one of the scheduled times
- currently engaged in intensive yoga practice (practice >3 days/wk)
- score >29 on the Beck depression scale modified for fibromyalgia
- currently undergoing disability application or involved in litigation
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 |
|---|---|---|
| Yoga of Awareness ProgramThe 8 week yoga program will meet in groups of about 8-10 persons. Each 2-hour session will include gentle stretching, strengthening, and balance poses; meditation exercises; breathing techniques; study of pertinent topics (eg, mind/body stress reactivity), and group discussions (eg, experiences while practicing yoga). Participants will be asked to practice yoga methods at home, guided by a DVD (or audio recordings). The program will be taught by a certified yoga teacher (RYT) who has extensive experience in teaching yoga to medical patients. | Behavioural | yoga condition |
Primary outcome
Fibromyalgia Impact Questionnaire Revised (FIQR)
Time frame: baseline, 3 months, 6 months
3 secondary outcomes
Vanderbilt Multidimensional Pain Coping Inventory (VMPCI)
Time frame: baseline, 3 months, 6 months
Chronic Pain Acceptance Questionnaire (CPAQ)
Time frame: baseline, 3 months, 6 months
Coping Strategies Questionnaire Catastrophizing Subscale (CSQCAT)
Time frame: baseline, 3 months, 6 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 16 Oct 2014.
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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.
James W Carson, PhD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga of Awareness Program in people with Fibromyalgia, run by Oregon Health and Science University 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 3 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 16 Oct 2014. 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. 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?
Fibromyalgia Impact Questionnaire Revised (FIQR) (time frame: baseline, 3 months, 6 months). 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 16 Oct 2014.