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

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ClinicalTrials.gov Identifier: NCT03890133
Recruitment Status : Recruiting
First Posted : March 26, 2019
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Juan Jiao, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Brief Summary:
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 .

Condition or disease Intervention/treatment Phase
Fibromyalgia Behavioral: Ba-Duan-Jin Drug: Pregabalin capsule Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Exploration the Therapeutic Mechanism of Ba-Duan-Jin in the Treatment of Fibromyalgia by Improving Intestinal Microecology
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
Drug Information available for: Pregabalin

Arm Intervention/treatment
Experimental: Ba-Duan-Jin group
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.
Behavioral: Ba-Duan-Jin
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.
Other Names:
  • Baduanjin
  • Eight Brocades
  • Eight-Section Brocade

Active Comparator: Pregabalin group

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.

Drug: Pregabalin capsule
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.

No Intervention: Healthy control group



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Gut microbiota sequencing results by analyzing metagenomes of microbial genes [ Time Frame: Baseline, week12 ]
    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).

  2. Serum Brain Derived Neurotrophic Factor (BDNF) levels [ Time Frame: Baseline, week12 ]
    Serum BDNF levels were measured in healthy control group and FM patients

  3. The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline. [ Time Frame: Baseline, week 4, week 8, and week 12. ]
    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

  4. Global Impression of Change (PGIC) questionnaire evaluated at week 12. [ Time Frame: 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).

  5. fMRI of the brain in patients with fibromyalgia [ Time Frame: Baseline, week12 ]
    To compare the changes in structure, connectivity and metabolic function of the brain in patients with fibromyalgia before and after treatment by fMRI.

  6. Serum Tyrosine kinase B (TrkB) levels [ Time Frame: Baseline, week12 ]
    Serum TrkB levels were measured in healthy control group and FM patients



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03890133


Contacts
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Contact: Li yan ting, MD 13120032955 liyanting0816@163.com

Locations
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China, Beijing
GAMhospital Recruiting
Beijing, Beijing, China
Contact: Li Yan Ting, MD    +8601088001132 ext +8601088001132    liyanting0816@163.com   
Contact: Jiao Juan , MD PhD    +8601088001132 ext +8601088001132    jiao.juan@hotmail.com   
Sponsors and Collaborators
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Additional Information:
Publications:
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Responsible Party: Juan Jiao, Deputy chief physician, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT03890133     History of Changes
Other Study ID Numbers: 81873294
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Juan Jiao, Guang'anmen Hospital of China Academy of Chinese Medical Sciences:
Fibromyalgia
Ba-Duan-Jin
Gut microbiota
Mechanism

Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Pregabalin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs