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
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Behavioral: Ba-Duan-Jin Drug: Pregabalin capsule||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|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|
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.
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.
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|
- 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.
- 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).
- Serum Brain Derived Neurotrophic Factor (BDNF) levels [ Time Frame: Baseline, week12 ]Serum BDNF levels were measured in healthy control group and FM patients
- 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
- 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).
- 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.
- Serum Tyrosine kinase B (TrkB) levels [ Time Frame: Baseline, week12 ]Serum TrkB levels were measured in healthy control group and FM patients
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
|Contact: Li yan ting, MDemail@example.com|
|Beijing, Beijing, China|
|Contact: Li Yan Ting, MD +8601088001132 ext +8601088001132 firstname.lastname@example.org|
|Contact: Jiao Juan , MD PhD +8601088001132 ext +8601088001132 email@example.com|