NCT03890133

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 26, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

October 21, 2024

Status Verified

October 1, 2024

Enrollment Period

3.2 years

First QC Date

March 17, 2019

Last Update Submit

October 17, 2024

Conditions

Fibromyalgia

Keywords

FibromyalgiaBa-Duan-JinGut microbiotaMechanism

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline, week4, week8, week12, week24

Secondary Outcomes (6)

  • Gut microbiota sequencing results by analyzing metagenomes of microbial genes

    Baseline, week12

  • Serum Brain Derived Neurotrophic Factor (BDNF) levels

    Baseline, week12

  • The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline.

    Baseline, week 4, week 8, and week 12.

  • Global Impression of Change (PGIC) questionnaire evaluated at week 12.

    Week 12.

  • fMRI of the brain in patients with fibromyalgia

    Baseline, week12

  • +1 more secondary outcomes

Study Arms (3)

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.

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.

Drug: Pregabalin capsule

Healthy control group

NO INTERVENTION

Interventions

Ba-Duan-JinBEHAVIORAL

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.

Also known as: Baduanjin, Eight Brocades, Eight-Section Brocade
Ba-Duan-Jin group
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.

Pregabalin group

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GAMhospital

Beijing, Beijing Municipality, China

Location

Related Publications (2)

  • 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.

    PMID: 30789154BACKGROUND

  • 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.

    PMID: 40589353DERIVED

Related Links

MeSH Terms

Conditions

Fibromyalgia

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy chief physician

Study Record Dates

First Submitted

March 17, 2019

First Posted

March 26, 2019

Study Start

April 1, 2019

Primary Completion

May 31, 2022

Study Completion

December 31, 2022

Last Updated

October 21, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)