FibromyalgiaNCT02401386
Eight Brocades (Ba Duan Jin) for Treating Patients With Fibromyalgia
A study testing The Eight Brocades in people with Fibromyalgia, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
In this randomized, usual therapy-controlled study, 62 patients with fibromyalgi (FM) were recruited with a ratio of 1:1. Trained and guided by Eight Brocades (EB) certified physicians, participant practiced EB one hour, twice a week for 12 weeks. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- The Eight Brocades
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- Mar 2015to Aug 2017
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Age 18 years or older.
- Fulfills the American College of Rheumatology (ACR) 1990 classification criteria for FM.
- On a stable variety and dosage of pharmacologic for FM ≥4 weeks
Who cannot join
- • Prior experience with EB or other similar types of Complementary and Alternative Medicine in the past 1 year such as Qi gong, Tai Chi and yoga since these share some of the principles of EB.
- Dementia, cancer, or other serious medical conditions limiting ability to participate in the Eight Brocades or strength training, as determined by the study physicians.
- Any other diagnosed medical condition known to contribute to FM symptomatology that is not under adequate control for the study period such as thyroid disease, inflammatory arthritis, systemic lupus erythematosus, rheumatoid arthritis, myositis, vasculitis or Sjogren's syndrome.
- Positive urine pregnancy test at baseline or planning pregnancy within the study period.
- Reside >70 miles from the research site.
Trial locations and contacts
1 site in 1 country.
China1 site
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100053
About this study
Official title: A Randomized Controlled Trial of Eight Brocades (Ba Duan Jin) to Improve Quality of Life in Patients With Fibromyalgia
In this randomized, usual therapy-controlled study, 62 patients with fibromyalgi (FM) were recruited with a ratio of 1:1. Trained and guided by Eight Brocades (EB) certified physicians, participant practiced EB one hour, twice a week for 12 weeks. Evaluation will be based on standard scales of pain, FM symptoms severity, degree of fatigue, depression, sleep quality and quality of life.
Read the detailed description
The EB, also written as Ba Duan Jin, or Baduanjin, or Eight-Section Brocade, is a set of Qigong exercises that originated in China and date back thousands of years. It is a mind-body practice that combines meditation with slow, gentle, graceful movements, as well as deep breathing and relaxation, to move vital energy (or qi) throughout the body and is practiced as a rehabilitation exercise for various kinds of diseases. It is considered a complex, multicomponent intervention that integrates physical, psychosocial, emotional, spiritual, and behavioral elements. Participants in the EB group received a modified EB adapted by Chinese Medicine Master Zhi-zheng Lu, which was added several joint exercise movements to the traditional EB forms to specifically tailor it for patients with rheumatic diseases.
FM is a common and complex clinical syndrome characterized by chronic and widespread musculoskeletal pain, fatigue, sleep disturbance, and physical and psychological impairment. Evidence-based guidelines suggest that exercise is beneficial for FM and has been advocated as a core component of its treatment. Because of EB's mind-body attributes and it is easy to learn, we assume that it could be well suited for the treatment of FM.
Patients enrolled in this trial will be randomly allocated into one of two groups: EB group and usual therapy-controlled group. Patients will be evaluated at baseline, at week 4, 8 and 12. The primary outcome measure was a Visual Analogue Scales for pain (PVAS). Secondary outcome measures included the following: the Revised FM Impact Questionnaire (FIQR), the Multidimensional Assessment of Fatigue (MAF), the Pittsburgh Sleep Quality Index (PSQI), the Beck Depression Inventory (BDI), the Perceived Stress Scale (PSS), and the Tender Points Count (TPC).
- Conditions
- Fibromyalgia
- Being tested
- The Eight Brocades
- Keywords
- Fibromyalgia; Eight Brocades; Baduanjin; Qigong; Pain severity
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Eight BrocadesBehavioural
Patients received closely supervised, group-format EB program and practiced EB revised by Chinese Medicine Master Zhi-zheng Lu for one hour, twice weekly for 12 weeksmovements, a review of principles, and breathing techniques in EB. Participants will be asked to practice EB at home for at least 16 minutes each day which is how long it takes to complete an EB exercise, using an instructional Digital Video Disc. The program will be taught by experienced EB masters.
| Study group | Role | What they receive |
|---|---|---|
| EB group | Experimental | Trained and guided by EB certified physicians, patients in EB group received closely supervised, group-format EB program and practiced EB for one hour, twice weekly for 12 weeks in the Guang'anmen Hospital. Receives: Behavioral: The Eight Brocades |
| Control group | No intervention | The participants in usual therapy-controlled group will stay on their previous treatment through 12 weeks. As compensation, they will be invited to receive LEB training for 12 weeks after the end of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of Visual Analogue Scales for pain (PVAS) from baseline to 12 weeks.
Measured: baseline, 4 weeks, 8 weeks, 12 weeks
The change of Fibromyalgia Impact Questionnaire (FIQ) from baseline to 12 weeks
Measured: baseline, 4 weeks, 8 weeks, 12 weeks
Secondary outcomes (5)
The change of the Short Form-36 Health Status Questionnaire (SF-36) from baseline to 12 weeks
Measured: baseline, 4 weeks, 8 weeks, 12 weeks
The change of Multidimensional Assessment Fatigue (MAF) from baseline to 12 weeks
Measured: baseline, 4 weeks, 8 weeks, 12 weeks
The change of Beck depression inventory (BDI) from baseline to 12 weeks
Measured: baseline, 4 weeks, 8 weeks, 12 weeks
The change of Perceived Stress Scale (PSS) from baseline to 12 weeks
Measured: baseline, 4 weeks, 8 weeks, 12 weeks
The change of Pittsburgh sleep quality index (PSQI) from baseline to 12 weeks
Measured: baseline, 4 weeks, 8 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionFeb 2017
- Study completionAug 2017
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
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Municipal Science & Technology Commission
- Responsible party
- Principal investigator, Juan Jiao, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Juan Jiao, M.D.,PhD, Principal investigator, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02401386
- Sponsor's protocol ID
- Z141107002514094
- Status last verified
- Jan 2018
- First submitted
- 24 Mar 2015
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Eight Brocades (Ba Duan Jin) to Improve Quality of Life in Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT02401386
- Acronym / sponsor ID
- Z141107002514094
- Conditions
- Fibromyalgia
- Keywords
- Fibromyalgia; Eight Brocades; Baduanjin; Qigong; Pain severity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- Beijing Municipal Science & Technology Commission
- Study start
- Mar 2015 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 27 Mar 2015 (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.
In this randomized, usual therapy-controlled study, 62 patients with fibromyalgi (FM) were recruited with a ratio of 1:1. Trained and guided by Eight Brocades (EB) certified physicians, participant practiced EB one hour, twice a week for 12 weeks. Evaluation will be based on standard scales of pain, FM symptoms severity, degree of fatigue, depression, sleep quality and quality of life.
Detailed description
The EB, also written as Ba Duan Jin, or Baduanjin, or Eight-Section Brocade, is a set of Qigong exercises that originated in China and date back thousands of years. It is a mind-body practice that combines meditation with slow, gentle, graceful movements, as well as deep breathing and relaxation, to move vital energy (or qi) throughout the body and is practiced as a rehabilitation exercise for various kinds of diseases. It is considered a complex, multicomponent intervention that integrates physical, psychosocial, emotional, spiritual, and behavioral elements. Participants in the EB group received a modified EB adapted by Chinese Medicine Master Zhi-zheng Lu, which was added several joint exercise movements to the traditional EB forms to specifically tailor it for patients with rheumatic diseases.
FM is a common and complex clinical syndrome characterized by chronic and widespread musculoskeletal pain, fatigue, sleep disturbance, and physical and psychological impairment. Evidence-based guidelines suggest that exercise is beneficial for FM and has been advocated as a core component of its treatment. Because of EB's mind-body attributes and it is easy to learn, we assume that it could be well suited for the treatment of FM.
Patients enrolled in this trial will be randomly allocated into one of two groups: EB group and usual therapy-controlled group. Patients will be evaluated at baseline, at week 4, 8 and 12. The primary outcome measure was a Visual Analogue Scales for pain (PVAS). Secondary outcome measures included the following: the Revised FM Impact Questionnaire (FIQR), the Multidimensional Assessment of Fatigue (MAF), the Pittsburgh Sleep Quality Index (PSQI), the Beck Depression Inventory (BDI), the Perceived Stress Scale (PSS), and the Tender Points Count (TPC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EB group | Experimental | Behavioral: The Eight BrocadesTrained and guided by EB certified physicians, patients in EB group received closely supervised, group-format EB program and practiced EB for one hour, twice weekly for 12 weeks in the Guang'anmen Hospital. |
| Control group | No intervention | –The participants in usual therapy-controlled group will stay on their previous treatment through 12 weeks. As compensation, they will be invited to receive LEB training for 12 weeks after the end of the study. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • Age 18 years or older.
Key exclusion criteria (5 listed)
- • Prior experience with EB or other similar types of Complementary and Alternative Medicine in the past 1 year such as Qi gong, Tai Chi and yoga since these share some of the principles of EB.
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 |
|---|---|---|
| The Eight BrocadesPatients received closely supervised, group-format EB program and practiced EB revised by Chinese Medicine Master Zhi-zheng Lu for one hour, twice weekly for 12 weeksmovements, a review of principles, and breathing techniques in EB. Participants will be asked to practice EB at home for at least 16 minutes each day which is how long it takes to complete an EB exercise, using an instructional Digital Video Disc. The program will be taught by experienced EB masters. | Behavioural | EB group |
Primary outcome
The change of Visual Analogue Scales for pain (PVAS) from baseline to 12 weeks.
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks
The change of Fibromyalgia Impact Questionnaire (FIQ) from baseline to 12 weeks
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks
5 secondary outcomes
The change of the Short Form-36 Health Status Questionnaire (SF-36) from baseline to 12 weeks
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks
The change of Multidimensional Assessment Fatigue (MAF) from baseline to 12 weeks
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks
The change of Beck depression inventory (BDI) from baseline to 12 weeks
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks
The change of Perceived Stress Scale (PSS) from baseline to 12 weeks
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks
The change of Pittsburgh sleep quality index (PSQI) from baseline to 12 weeks
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks
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 23 Jan 2018.
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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.
Juan Jiao, M.D.,PhD principal investigator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Eight Brocades in people with Fibromyalgia, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
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 5 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 23 Jan 2018. 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 China. 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 change of Visual Analogue Scales for pain (PVAS) from baseline to 12 weeks. (time frame: baseline, 4 weeks, 8 weeks, 12 weeks). The study lists 2 primary outcomes in all. 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 23 Jan 2018.