FibromyalgiaNCT06410430
Exploration the Mechanism of Ba-Duan-Jin in the Treatment of Fibromyalgia Based on Brain-gut Axis
A study testing Ba-Duan-Jin in people with Fibromyalgia, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial summary
To investigate the mechanism by Ba-Duan-Jin in the treatment of fibromyalgia. Twenty eligible fibromyalgia patients were selected, and were trained and guided online by an experienced Ba-Duan-Jin instructor with reference to the standard operating procedure (SOP) for a 12-week course of 1 hour twice a week. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Ba-Duan-Jin
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 31 Jan 2024to 30 Jun 2024
- 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
- 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 or 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria;
- Be over 18 years of age;
- Female;
- Right-handedness;
- Sign informed consent.
Who cannot join
- be less than 40mm of pain VAS score;
- had received any treatments for fibromyalgia or probiotic bacteria within 2 weeks;
- had received antibiotics within 4 weeks;
- had practiced Ba-Duan-Jin, Tai Chi, yoga, or other forms of Qigong within previous 12 months;
- had severe depression or anxiety;
- pregnancy or planned pregnancy within the study period;
Show all 9Show fewer
- had any poorly-controlled comorbid medical conditions, such as dementia, cancer, thyroid disease, inflammatory arthritis;
- patients with a history of head trauma, cerebral infarction or cerebral haemorrhage
- contraindications for MRI,including metal implants, cardiac pacemaker,false tooth, surgical artery clips, metal tattoos or claustrophobia;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guang'anmen Hospital
Beijing, Beijing Municipality, 100053
Juan Jiao, PhD, +8688001060, jiao.juan@hotmail.com
About this study
Official title: Exploration the Therapeutic Mechanism of Ba-Duan-Jin in the Treatment of Fibromyalgia by Improving Gut Microbiota and Brain Magnetic Resonance Imaging
To investigate the mechanism by Ba-Duan-Jin in the treatment of fibromyalgia. Twenty eligible fibromyalgia patients were selected, and were trained and guided online by an experienced Ba-Duan-Jin instructor with reference to the standard operating procedure (SOP) for a 12-week course of 1 hour twice a week. The evaluation points were 0, 4, 8, and 12 weeks. The change of pain Visual Analogue Score (VAS) and tener point count (TPC) post-treatment were evaluated. And blood, feces, and brain fMRI were collected from the patients at 0 and 12 weeks to compare the changes in gut microbiota, metabolites, and brain function networks before and after the intervention with the 16SrRNA sequencing, targeted metabolomics, and real-time Quantitative Polymerase Chain Reaction (PCR).
- Conditions
- Fibromyalgia
- Being tested
- Ba-Duan-Jin
- 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 ovements,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.
| Study group | Role | What they receive |
|---|---|---|
| Ba-Duan-Jin group | Experimental | The participants will be trained and guided online by an experienced Ba-Duan-Jin instructor with reference to the standard operating procedure (SOP) for a 12-week course of 1 hour twice a week. Receives: Behavioral: Ba-Duan-Jin |
| 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
The change of Tender Point Count (TPC) from baseline
TPC, the 18 body points of the 1990 American College of Rheumatology (ACR) Research Classification Criteria for fibromyalgia, which in healthy subjects do not cause pain, whereas in patients with fibromyalgia no fewer than 11 are painful
Measured: Baseline, week4, week8, week12
Secondary outcomes (6)
Gut microbiota sequencing results by analyzing metagenomes of microbial genes
Fecal samples are obtained from the Ba-Duan-Jin 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 fatty acids metabolism results by UPLC-MS/MS
Blood samples are obtained from the Ba-Duan-Jin group and control group. Ultra Performance Liquid Chromatography Tandem Mass Spectrometry will be performed. The SIMCA will be selected for Orthogonal Partial Least Squares-Discriminant Analysis. The Kyoto encyclopedia of genes and genomes will be selected for functional enrichment analysis of differential metabolites.
Measured: Baseline, week12
Brain morphology in fibromyalgia patients measured by structural MRI
To compare the changes in brain structure and morphology in patients with fibromyalgia before and after treatment by structural MRI. The images were acquired by a Siemens 3.0T Skyra scanner (Siemens; Munich, Germany) using fast spoiled gradient-echo sequence. Images contain whole brain, grey matter, white matter, atlas-based regions of interest for the patient group and healthy controls. The structural MRI images were processed with CAT 12 software (Version12.7, r1700). In detail, the voxel-based morphometry pipeline includes initial and refined voxel-based processing.
Measured: Baseline, week12
Brain functional connectivity in fibromyalgia patients measured by function MRI
To compare the changes in connectivity and metabolic function of the brain in patients with fibromyalgia before and after treatment by function MRI. The scanning sequence is set up under the guidance of an imaging professional, while ensuring that the participants undergo the MRI scans with their eyes closed but awake; head movements do not exceed 1.5 mm in translation in any direction and 1.5° in rotation in any direction.
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, week4, week8, week12
The change of the Short Form-36 Health Status Questionnaire (SF-36) from baseline
The Short Form-36 Health Status Questionnaire (SF-36), which measured health-related quality of life (range, 0 to 100, with higher scores indicating better perceived health status
Measured: Baseline, week4, week8, week12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start31 Jan 2024
- Primary completion31 May 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Jiao, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410430
- Sponsor's protocol ID
- CI2021A0151
- Status last verified
- May 2024
- First submitted
- 24 Apr 2024
- Last updated
- 13 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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
Study at a glance
From the registry record, last updated by the sponsor on 13 May 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 Gut Microbiota and Brain Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT06410430
- Acronym / sponsor ID
- CI2021A0151
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 13 May 2024 (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.
To investigate the mechanism by Ba-Duan-Jin in the treatment of fibromyalgia. Twenty eligible fibromyalgia patients were selected, and were trained and guided online by an experienced Ba-Duan-Jin instructor with reference to the standard operating procedure (SOP) for a 12-week course of 1 hour twice a week. The evaluation points were 0, 4, 8, and 12 weeks. The change of pain Visual Analogue Score (VAS) and tener point count (TPC) post-treatment were evaluated. And blood, feces, and brain fMRI were collected from the patients at 0 and 12 weeks to compare the changes in gut microbiota, metabolites, and brain function networks before and after the intervention with the 16SrRNA sequencing, targeted metabolomics, and real-time Quantitative Polymerase Chain Reaction (PCR).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ba-Duan-Jin group | Experimental | Behavioral: Ba-Duan-JinThe participants will be trained and guided online by an experienced Ba-Duan-Jin instructor with reference to the standard operating procedure (SOP) for a 12-week course of 1 hour twice a week. |
| Healthy control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Meet the 1990 American College of Rheumatology (ACR) Research Classification Criteria for fibromyalgia or 2016 Revisions to the 2010/2011 fibromyalgia diagnostic criteria;
- Be over 18 years of age;
- Female;
- Right-handedness;
- Sign informed consent.
Key exclusion criteria (9 listed)
- be less than 40mm of pain VAS score;
- had received any treatments for fibromyalgia or probiotic bacteria within 2 weeks;
- had received antibiotics within 4 weeks;
- had practiced Ba-Duan-Jin, Tai Chi, yoga, or other forms of Qigong within previous 12 months;
- had severe depression or anxiety;
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 ovements,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 |
Primary outcome
The change of the Visual Analogue Scale (VAS) for pain from baseline
Time frame: Baseline, week4, week8, week12
Pain VAS, range from 0 to 100 mm with higher score indicating more severe pain
The change of Tender Point Count (TPC) from baseline
Time frame: Baseline, week4, week8, week12
TPC, the 18 body points of the 1990 American College of Rheumatology (ACR) Research Classification Criteria for fibromyalgia, which in healthy subjects do not cause pain, whereas in patients with fibromyalgia no fewer than 11 are painful
6 secondary outcomes
Gut microbiota sequencing results by analyzing metagenomes of microbial genes
Time frame: Baseline, week12
Serum fatty acids metabolism results by UPLC-MS/MS
Time frame: Baseline, week12
Brain morphology in fibromyalgia patients measured by structural MRI
Time frame: Baseline, week12
Brain functional connectivity in fibromyalgia patients measured by function MRI
Time frame: Baseline, week12
The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline
Time frame: Baseline, week4, week8, week12
The change of the Short Form-36 Health Status Questionnaire (SF-36) from baseline
Time frame: Baseline, week4, week8, week12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 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.
- Ba-Duan-Jin alleviates pain and fibromyalgia-related symptoms in patients with fibromyalgia: results of a randomised controlled trial.Link provided by the sponsor.
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
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
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.
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 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 5 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 13 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shiya Wu, MD (+86 010-88001060, 2778823398@qq.com), or a site near the patient. 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). 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?
On the ClinicalTrials.gov record for NCT06410430, which also lists 1 linked publication.
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 13 May 2024.