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

Primary Purpose

Fibromyalgia

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Ba-Duan-Jin
Pregabalin capsule
Sponsored by
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Fibromyalgia focused on measuring Fibromyalgia, Ba-Duan-Jin, Gut microbiota, Mechanism

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • GAMhospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Ba-Duan-Jin group

Pregabalin group

Healthy control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
Serum Brain Derived Neurotrophic Factor (BDNF) levels
Serum BDNF levels were measured in healthy control group and FM patients
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
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).
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.
Serum Tyrosine kinase B (TrkB) levels
Serum TrkB levels were measured in healthy control group and FM patients

Full Information

First Posted
March 17, 2019
Last Updated
November 6, 2021
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03890133
Brief Title
Exploration the Mechanism of Ba-Duan-Jin Therapy in the Management of Fibromyalgia
Official Title
Exploration the Therapeutic Mechanism of Ba-Duan-Jin in the Treatment of Fibromyalgia by Improving Intestinal Microecology
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
May 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

4. Oversight

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

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, Ba-Duan-Jin, Gut microbiota, Mechanism

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ba-Duan-Jin group
Arm Type
Experimental
Arm Description
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.
Arm Title
Pregabalin group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Healthy control group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Ba-Duan-Jin
Other Intervention Name(s)
Baduanjin, Eight Brocades, Eight-Section Brocade
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Pregabalin capsule
Intervention Description
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 Outcome Measure Information:
Title
The change of the Visual Analogue Scale (VAS) for pain from baseline.
Description
Pain VAS, range from 0 to 100 mm with higher score indicating more severe pain.
Time Frame
Baseline, week4, week8, week12, week24
Secondary Outcome Measure Information:
Title
Gut microbiota sequencing results by analyzing metagenomes of microbial genes
Description
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).
Time Frame
Baseline, week12
Title
Serum Brain Derived Neurotrophic Factor (BDNF) levels
Description
Serum BDNF levels were measured in healthy control group and FM patients
Time Frame
Baseline, week12
Title
The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline.
Description
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
Time Frame
Baseline, week 4, week 8, and week 12.
Title
Global Impression of Change (PGIC) questionnaire evaluated at week 12.
Description
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).
Time Frame
Week 12.
Title
fMRI of the brain in patients with fibromyalgia
Description
To compare the changes in structure, connectivity and metabolic function of the brain in patients with fibromyalgia before and after treatment by fMRI.
Time Frame
Baseline, week12
Title
Serum Tyrosine kinase B (TrkB) levels
Description
Serum TrkB levels were measured in healthy control group and FM patients
Time Frame
Baseline, week12

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li yan ting, MD
Phone
13120032955
Email
liyanting0816@163.com
Facility Information:
Facility Name
GAMhospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Yan Ting, MD
Phone
+8601088001132
Ext
+8601088001132
Email
liyanting0816@163.com
First Name & Middle Initial & Last Name & Degree
Jiao Juan, MD PhD
Phone
+8601088001132
Ext
+8601088001132
Email
jiao.juan@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30789154
Citation
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.
Results Reference
background

Learn more about this trial

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

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