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NCT Number: NCT03890133

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

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 .

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

GAMhospital

Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ba-Duan-Jin

Behavioral

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

Pregabalin capsule

Drug

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 26, 2019
Registry last updated
Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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