Fibromyalgia PainNCT00938834
Qigong For Treatment Of Fibromyalgia
A study testing CFQ Qigong in people with Fibromyalgia Pain, run by Nova Scotia Health Authority at 1 site in Canada.
Trial summary
Fibromyalgia is a syndrome characterized by widespread musculoskeletal pain and hyperalgesia with a prevalence of 2-4% in the general population; it is often accompanied by fatigue, insomnia, anxiety, depression and other conditions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia Pain
- What is being tested?
- CFQ Qigong
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2009to Sep 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 years
- A diagnosis of fibromyalgia according to American College of Rheumatology criteria
- Moderate to severe pain, as defined by an average 7-day pain score of greater than 4.0 on an 11-point numerical rating scale for pain intensity
- Pain medications must have been stable for at least 14 days.
- Ability to follow the protocol (with reference to cognitive and situational conditions, (e.g. stable housing, ability to attend follow-up visits, motivation and commitment to self practice of CFQ Qigong for 45-60 minutes per day).
- Willing and able to give written informed consent
Who cannot join
- Presence of clinically significant medical disorder on history or physical exam that would compromise the participants' safety in the trial as judged by the study physician
- Already practicing CFQ Qigong on a regular basis
- Unable to commit to 45-60 minutes of CFQ Qigong practice per day
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial Of Qigong For Treatment Of Fibromyalgia
Fibromyalgia is a syndrome characterized by widespread musculoskeletal pain and hyperalgesia with a prevalence of 2-4% in the general population; it is often accompanied by fatigue, insomnia, anxiety, depression and other conditions. It is a difficult condition to treat, and only recently have drugs been approved by the FDA specifically for the treatment of this condition (Lyrica was approved in 2007, Duloxetine in 2008). There are now several clinical trials of drugs commonly used to treat neuropathic pain (amitriptyline, gabapentin, pregabalin, acetaminophen/tramadol, duloxetine, minserin) reporting some degree of efficacy in treating fibromyalgia. This efficacy makes it practical to consider fibromyalgia along with other neuropathic pain conditions. However, such drug trials report only partial efficacy in relieving pain and/or other symptoms. Current treatment recommendations indicate the need for a multimodal approach; this includes medical management using appropriate drug therapies, psychological therapies, exercise and complementary approaches. The current proposal is for a randomized controlled trial to compare qigong (a complementary modality) to a wait list control to determine if qigong is a useful complementary therapy for fibromyalgia.
The investigators recently completed a pilot trial in which they examined a specific form of qigong (CFQ Qigong, available locally in Halifax), and observed beneficial effects against pain, fibromyalgia impact, and on quality of life scores; importantly, these benefits were all sustained for 6 months to the end of the trial. On the basis of these preliminary observations, the investigators now propose a controlled trial in which CFQ Qigong is compared to a wait list control group. The latter group will be offered qigong training at the end of the trial, so could really be characterized as a delayed treatment group. The study will consist of a 3-day training period, weekly review of technique sessions for 8 weeks, daily practice for 8 weeks, with assessments at baseline, at 8 weeks following the training and practice, and follow-up assessments at 4 and 6 months. Study outcomes will include: (a) pain (numeric rating scale - pain intensity), (b) impact (fibromyalgia impact questionnaire), (c) quality of life measures (SF-36), (d) patient assessments (patient global impression of change and satisfaction scales), (e) sleep measures (Pittsburgh sleep quality index, actigraphy, sleep diary). In addition to these assessments, the investigators will also conduct qualitative assessments in which participants provide a more open-ended assessment of their health status at these same intervals. The main hypothesis being examined is that CFQ Qigong will produce benefits compared to the wait list group.
- Conditions
- Fibromyalgia Pain
- Being tested
- CFQ Qigong
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CFQ QigongOther
CFQ Qigong training session training will consist of three half days of training in the technique. Following the training sessions, participants will return to the study site on a weekly basis for the first 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| CFQ Qigong training group | Active comparator | Qigong training con- sisted of an initial workshop conducted over three con- secutive half-days by a qualified CFQ instructor. Participants received training in level 1 CFQ; this con- sisted of instruction in seven key movements known as "the hexagram" and ancillary exercises. Hexagram move- ments consist of choreographed movements that emphasize softness, relaxation, downward releases and full body distribution of "qi". Once initial training was complete, participants were asked to practice CFQ at home for 45 to 60 minutes per day for eight weeks; time could be broken up into shorter sessions during the day. Participants returned for a 60 minute weekly review/group practice sessions for these eight weeks. Receives: Other: CFQ Qigong |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure will be the change in mean daily pain diary score from baseline (average pain score over 7 days pre-treatment) to the final week of Qigong treatment.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2009 (estimated)
- Study startAug 2009
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fibromyalgia PainStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary Lynch, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00938834
- Sponsor's protocol ID
- CDHA-RS/2010-094
- Status last verified
- Oct 2012
- First submitted
- 13 Jul 2009
- Last updated
- 1 Nov 2012
- Results posted
- No
Publications
Lynch M, Sawynok J, Hiew C, Marcon D. A randomized controlled trial of qigong for fibromyalgia. Arthritis Res Ther. 2012 Aug 3;14(4):R178. doi: 10.1186/ar3931.
PubMed 22863206Castro MP, Goldstein N. Mismatch repair deficiency associated with complete remission to combination programmed cell death ligand immune therapy in a patient with sporadic urothelial carcinoma: immunotheranostic considerations. J Immunother Cancer. 2015 Dec 15;3:58. doi: 10.1186/s40425-015-0104-y. eCollection 2015.
PubMed 26674132
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Of Qigong For Treatment Of Fibromyalgia
- ClinicalTrials.gov ID
- NCT00938834
- Acronym / sponsor ID
- CDHA-RS/2010-094
- Conditions
- Fibromyalgia Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 14 Jul 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 syndrome characterized by widespread musculoskeletal pain and hyperalgesia with a prevalence of 2-4% in the general population; it is often accompanied by fatigue, insomnia, anxiety, depression and other conditions. It is a difficult condition to treat, and only recently have drugs been approved by the FDA specifically for the treatment of this condition (Lyrica was approved in 2007, Duloxetine in 2008). There are now several clinical trials of drugs commonly used to treat neuropathic pain (amitriptyline, gabapentin, pregabalin, acetaminophen/tramadol, duloxetine, minserin) reporting some degree of efficacy in treating fibromyalgia. This efficacy makes it practical to consider fibromyalgia along with other neuropathic pain conditions. However, such drug trials report only partial efficacy in relieving pain and/or other symptoms. Current treatment recommendations indicate the need for a multimodal approach; this includes medical management using appropriate drug therapies, psychological therapies, exercise and complementary approaches. The current proposal is for a randomized controlled trial to compare qigong (a complementary modality) to a wait list control to determine if qigong is a useful complementary therapy for fibromyalgia.
The investigators recently completed a pilot trial in which they examined a specific form of qigong (CFQ Qigong, available locally in Halifax), and observed beneficial effects against pain, fibromyalgia impact, and on quality of life scores; importantly, these benefits were all sustained for 6 months to the end of the trial. On the basis of these preliminary observations, the investigators now propose a controlled trial in which CFQ Qigong is compared to a wait list control group. The latter group will be offered qigong training at the end of the trial, so could really be characterized as a delayed treatment group. The study will consist of a 3-day training period, weekly review of technique sessions for 8 weeks, daily practice for 8 weeks, with assessments at baseline, at 8 weeks following the training and practice, and follow-up assessments at 4 and 6 months. Study outcomes will include: (a) pain (numeric rating scale - pain intensity), (b) impact (fibromyalgia impact questionnaire), (c) quality of life measures (SF-36), (d) patient assessments (patient global impression of change and satisfaction scales), (e) sleep measures (Pittsburgh sleep quality index, actigraphy, sleep diary). In addition to these assessments, the investigators will also conduct qualitative assessments in which participants provide a more open-ended assessment of their health status at these same intervals. The main hypothesis being examined is that CFQ Qigong will produce benefits compared to the wait list group.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CFQ Qigong training group | Active comparator | Other: CFQ QigongQigong training con- sisted of an initial workshop conducted over three con- secutive half-days by a qualified CFQ instructor. Participants received training in level 1 CFQ; this con- sisted of instruction in seven key movements known as "the hexagram" and ancillary exercises. Hexagram move- ments consist of choreographed movements that emphasize softness, relaxation, downward releases and full body distribution of "qi". Once initial training was complete, participants were asked to practice CFQ at home for 45 to 60 minutes per day for eight weeks; time could be broken up into shorter sessions during the day. Participants returned for a 60 minute weekly review/group practice sessions for these eight weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age greater than or equal to 18 years
- A diagnosis of fibromyalgia according to American College of Rheumatology criteria
- Moderate to severe pain, as defined by an average 7-day pain score of greater than 4.0 on an 11-point numerical rating scale for pain intensity
- Pain medications must have been stable for at least 14 days.
- Ability to follow the protocol (with reference to cognitive and situational conditions, (e.g. stable housing, ability to attend follow-up visits, motivation and commitment to self practice of CFQ Qigong for 45-60 minutes per day).
Key exclusion criteria (3 listed)
- Presence of clinically significant medical disorder on history or physical exam that would compromise the participants' safety in the trial as judged by the study physician
- Already practicing CFQ Qigong on a regular basis
- Unable to commit to 45-60 minutes of CFQ Qigong practice per day
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 |
|---|---|---|
| CFQ QigongCFQ Qigong training session training will consist of three half days of training in the technique. Following the training sessions, participants will return to the study site on a weekly basis for the first 8 weeks. | Other | CFQ Qigong training group |
Primary outcome
The primary outcome measure will be the change in mean daily pain diary score from baseline (average pain score over 7 days pre-treatment) to the final week of Qigong treatment.
Time frame: 7 days
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 1 Nov 2012.
- Results publication: PubMed 22863206Lynch M, Sawynok J, Hiew C, Marcon D. A randomized controlled trial of qigong for fibromyalgia. Arthritis Res Ther. 2012 Aug 3;14(4):R178. doi: 10.1186/ar3931.
- Derived from this study: PubMed 26674132Castro MP, Goldstein N. Mismatch repair deficiency associated with complete remission to combination programmed cell death ligand immune therapy in a patient with sporadic urothelial carcinoma: immunotheranostic considerations. J Immunother Cancer. 2015 Dec 15;3:58. doi: 10.1186/s40425-015-0104-y. eCollection 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CFQ Qigong in people with Fibromyalgia Pain, run by Nova Scotia Health Authority at 1 site in Canada.
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 6 inclusion and 3 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 1 Nov 2012. 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 Canada. 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?
The primary outcome measure will be the change in mean daily pain diary score from baseline (average pain score over 7 days pre-treatment) to the final week of Qigong treatment. (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00938834, which also lists 2 linked publications.
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 1 Nov 2012.