FibromyalgiaNCT03890133

Exploration the Mechanism of Ba-Duan-Jin Therapy in the Management of Fibromyalgia

A study testing Ba-Duan-Jin and Pregabalin capsule in people with Fibromyalgia, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for: Fibromyalgia
What is being tested?: Ba-Duan-Jin and Pregabalin capsule
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteChina
Study dates: 1 Apr 2019to 31 Dec 2022
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
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

meet the 1990 American College of Rheumatology (ACR) Research Classification Criteria for fibromyalgia and 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria;
be between the ages of 18 to 70 years;
not taking medication for FM for at least 4 weeks;
no special eating habits.

Who cannot join

had practiced Ba-Duan-Jin, Tai Chi, yoga or other forms of Qigong exercise within 12 months of their recruitment to the study;
be less than 40mm of pain VAS score;
had renal failure, severe depression or anxiety;
had any poorly-controlled comorbid medical conditions, such as dementia, cancer, thyroid disease, inflammatory arthritis;
pregnancy or planned pregnancy within the study period;
patients residing more than 70 miles from the research site;

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patients with a history of head trauma;
a smoker or drinker;
contraindications for MRI,including metal implants, cardiac pacemaker,false tooth, surgical artery clips, metal tattoos or claustrophobia;
patients with cerebral infarction or cerebral hemorrhage.

Trial locations and contacts

1 site in 1 country.

China1 site

GAMhospital
Beijing, Beijing Municipality

Other trials in China

About this study

Official title: Exploration the Therapeutic Mechanism of Ba-Duan-Jin in the Treatment of Fibromyalgia by Improving Intestinal Microecology

Fibromyalgia (FM) is a chronic debilitating musculoskeletal pain syndrome. "Central sensitization" is an important mechanism of the disease. Recent studies have shown that "microbiome-gut-brain axis" imbalance may be one of the important mechanisms of "central sensitization". The purpose of this study was to investigate the therapeutic mechanism of Ba-Duan-Jin therapy in the treatment of fibromyalgia by improving intestinal microecology. The mechanism was evaluated by comparing the results of brain functional MRI (fMRI) and microbacterial analysis of the patients' stool pre and post treatment .

Conditions: Fibromyalgia
Being tested: Ba-Duan-Jin, Pregabalin capsule
Keywords: Fibromyalgia, Ba-Duan-Jin, Gut microbiota, Mechanism
Medical subject headings: Fibromyalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ba-Duan-JinBehavioural
Also called Baduanjin, Eight Brocades, Eight-Section Brocade
Ba-Duan-Jin is a common form of "self-healthcare" Qigong exercise that has been practiced by Chinese people for at least eight hundred years.It consists of eight sets of simple movements. By combining meditation with slow, graceful movements,deep breathing, and relaxation, Ba-Duan-Jin practitioners believe it has the ability to move vital energy (Qi) throughout the body. Ba-Duan-Jin is also considered to be a multicomponent intervention that integrates physical, psychosocial, emotional, spiritual, and behavioral elements. While the biological mechanisms remain unclear.
Pregabalin capsuleDrug
Pregabalin is one of the three medications (pregabalin, duloxetine, and milnacipran) that have been approved by the Food and Drug Administration (FDA) to treat fibromyalgia in US, and the only medicine that has been approved in China.

Study groups in NCT03890133
Study group	Role	What they receive
Ba-Duan-Jin group	Experimental	The participants will be guided by a research staff to do the Ba-Duan-Jin therapy for 50 minutes twice weekly for 12 weeks, in the outpatient section of the hospital; Pregabalin placebo treatment will be administered at bedtime once a day, starting at 150 mg for the first week, and increase to the dose of 300 mg from the second week. After one week, if 300 mg dose is tolerable, then maintain it for 10 additional weeks, if not, then go back to the 150 mg dose for 10 additional weeks. Receives: Behavioral: Ba-Duan-Jin
Pregabalin group	Active comparator	Wellness education and muscle relaxation exercise program: This program will be held for 50 minutes twice weekly for twelve weeks, containing 10-minute wellness education, 10-minute doctor-patient discussion, and 30-minute guided muscle relaxation exercise. Active pregabalin capsules: As same usage as the placebo pregabalin capsules. Receives: Drug: Pregabalin capsule
Healthy control group	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

The change of the Visual Analogue Scale (VAS) for pain from baseline.
Pain VAS, range from 0 to 100 mm with higher score indicating more severe pain.
Measured: Baseline, week4, week8, week12, week24

Secondary outcomes (6)

Gut microbiota sequencing results by analyzing metagenomes of microbial genes
Fecal samples are obtained from the experimental group and control group. After extracting DNA from fecal samoles, high-throughput Illumina sequencing, gene classification, abundance calculation, functional and metabolic annotation will be performed on the extracted DNA. The Bowtie2, BWA and Soap2 will be selected for the comparison software. The condition of comparison is to obtain the comparison results of 95% identity (and above).
Measured: Baseline, week12
Serum Brain Derived Neurotrophic Factor (BDNF) levels
Serum BDNF levels were measured in healthy control group and FM patients
Measured: Baseline, week12
The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline.
A self-administered questionnaire with 10 subscales, measuring fibromyalgia symptoms and function domains. FIQR total score ranges from 0 to 100, with higher scores indicating more severe symptoms
Measured: Baseline, week 4, week 8, and week 12.
Global Impression of Change (PGIC) questionnaire evaluated at week 12.
A questionnaire determine any change in overall symptom status from the beginning of the study to its conclusion (score range, 1 [very much improved] to 7 [very much worse).
Measured: Week 12.
fMRI of the brain in patients with fibromyalgia
To compare the changes in structure, connectivity and metabolic function of the brain in patients with fibromyalgia before and after treatment by fMRI.
Measured: Baseline, week12
Serum Tyrosine kinase B (TrkB) levels
Serum TrkB levels were measured in healthy control group and FM patients
Measured: Baseline, week12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Apr 201931 Dec 2022

First posted26 Mar 2019
Study start1 Apr 2019
Primary completion31 May 2022
Study completion31 Dec 2022

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 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: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03890133
Sponsor's protocol ID: 81873294
Status last verified: Oct 2024
First submitted: 17 Mar 2019
Last updated: 21 Oct 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Jiao J, Russell IJ, Wang W, Wang J, Zhao YY, Jiang Q. Ba-Duan-Jin alleviates pain and fibromyalgia-related symptoms in patients with fibromyalgia: results of a randomised controlled trial. Clin Exp Rheumatol. 2019 Nov-Dec;37(6):953-962. Epub 2019 Feb 15.
PubMed 30789154
Wu S, Jing B, Wang Y, Long M, Li Y, Li Z, Jiao J. Two Neuroanatomical Subtypes in Fibromyalgia Patients: Distinct Morphological Patterns and Treatment Outcomes. CNS Neurosci Ther. 2025 Jul;31(7):e70500. doi: 10.1111/cns.70500.
PubMed 40589353

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
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Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
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Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
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Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
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Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
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All Fibromyalgia trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Exploration the Therapeutic Mechanism of Ba-Duan-Jin in the Treatment of Fibromyalgia by Improving Intestinal Microecology
ClinicalTrials.gov ID: NCT03890133
Acronym / sponsor ID: 81873294
Conditions: Fibromyalgia
Keywords: Fibromyalgia, Ba-Duan-Jin, Gut microbiota, Mechanism
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
Study start: 1 Apr 2019 (actual)
Primary completion: 31 May 2022 (actual)
Study completion: 31 Dec 2022 (actual)
First posted: 26 Mar 2019 (actual)
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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Ba-Duan-Jin group	Experimental	Behavioral: Ba-Duan-JinThe participants will be guided by a research staff to do the Ba-Duan-Jin therapy for 50 minutes twice weekly for 12 weeks, in the outpatient section of the hospital; Pregabalin placebo treatment will be administered at bedtime once a day, starting at 150 mg for the first week, and increase to the dose of 300 mg from the second week. After one week, if 300 mg dose is tolerable, then maintain it for 10 additional weeks, if not, then go back to the 150 mg dose for 10 additional weeks.
Pregabalin group	Active comparator	Drug: Pregabalin capsuleWellness education and muscle relaxation exercise program: This program will be held for 50 minutes twice weekly for twelve weeks, containing 10-minute wellness education, 10-minute doctor-patient discussion, and 30-minute guided muscle relaxation exercise. Active pregabalin capsules: As same usage as the placebo pregabalin capsules.
Healthy control group	No intervention	–

Who may qualify

Ages: 18 to 70 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

meet the 1990 American College of Rheumatology (ACR) Research Classification Criteria for fibromyalgia and 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria;
be between the ages of 18 to 70 years;
not taking medication for FM for at least 4 weeks;
no special eating habits.

Key exclusion criteria (10 listed)

had practiced Ba-Duan-Jin, Tai Chi, yoga or other forms of Qigong exercise within 12 months of their recruitment to the study;
be less than 40mm of pain VAS score;
had renal failure, severe depression or anxiety;
had any poorly-controlled comorbid medical conditions, such as dementia, cancer, thyroid disease, inflammatory arthritis;
pregnancy or planned pregnancy within the study period;

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
Ba-Duan-JinAlso: Baduanjin, Eight Brocades, Eight-Section BrocadeBa-Duan-Jin is a common form of "self-healthcare" Qigong exercise that has been practiced by Chinese people for at least eight hundred years.It consists of eight sets of simple movements. By combining meditation with slow, graceful movements,deep breathing, and relaxation, Ba-Duan-Jin practitioners believe it has the ability to move vital energy (Qi) throughout the body. Ba-Duan-Jin is also considered to be a multicomponent intervention that integrates physical, psychosocial, emotional, spiritual, and behavioral elements. While the biological mechanisms remain unclear.	Behavioural	Ba-Duan-Jin group
Pregabalin capsulePregabalin is one of the three medications (pregabalin, duloxetine, and milnacipran) that have been approved by the Food and Drug Administration (FDA) to treat fibromyalgia in US, and the only medicine that has been approved in China.	Drug	Pregabalin group

Primary outcome

The change of the Visual Analogue Scale (VAS) for pain from baseline.
Time frame: Baseline, week4, week8, week12, week24
Pain VAS, range from 0 to 100 mm with higher score indicating more severe pain.

6 secondary outcomes

Gut microbiota sequencing results by analyzing metagenomes of microbial genes
Time frame: Baseline, week12
Serum Brain Derived Neurotrophic Factor (BDNF) levels
Time frame: Baseline, week12
The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline.
Time frame: Baseline, week 4, week 8, and week 12.
Global Impression of Change (PGIC) questionnaire evaluated at week 12.
Time frame: Week 12.
fMRI of the brain in patients with fibromyalgia
Time frame: Baseline, week12
Serum Tyrosine kinase B (TrkB) levels
Time frame: Baseline, week12

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 21 Oct 2024.
Background: PubMed 30789154Jiao J, Russell IJ, Wang W, Wang J, Zhao YY, Jiang Q. Ba-Duan-Jin alleviates pain and fibromyalgia-related symptoms in patients with fibromyalgia: results of a randomised controlled trial. Clin Exp Rheumatol. 2019 Nov-Dec;37(6):953-962. Epub 2019 Feb 15.
Derived from this study: PubMed 40589353Wu S, Jing B, Wang Y, Long M, Li Y, Li Z, Jiao J. Two Neuroanatomical Subtypes in Fibromyalgia Patients: Distinct Morphological Patterns and Treatment Outcomes. CNS Neurosci Ther. 2025 Jul;31(7):e70500. doi: 10.1111/cns.70500.
Ba-Duan-Jin alleviates pain and fibromyalgia-related symptoms in patients with fibromyalgia: results of a randomised controlled trial.Link provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Fibromyalgia

Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
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Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
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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 Ba-Duan-Jin and Pregabalin capsule 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 4 inclusion and 10 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 21 Oct 2024. 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 the Visual Analogue Scale (VAS) for pain from baseline. (time frame: Baseline, week4, week8, week12, week24). 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 NCT03890133, 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 21 Oct 2024.