Comparison of Ba-Duan-Jin and Pregabalin in Patients With Fibromyalgia

December 3, 2022 updated by: Juan Jiao, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Comparison the Treatment Effects Between Ba-Duan-Jin and Pregabalin in Patients With Fibromyalgia

Fibromyalgia is a chronic debilitating musculoskeletal pain syndrome. Pregabalin is the only medication that has been approved to treat fibromyalgia in China. Currently, there has been a growing interest in the development of non-pharmacological therapies. Ba-Duan-Jin is an ancient Chinese exercise for health promotion yet easy to learn. Findings from our previous study showed an effectiveness and good safety of Ba-Duan-Jin in patients with fibromyalgia. This study is to evaluate the effectiveness comparison of Ba-Duan-Jin and pregabalin in managing fibromyalgia symptoms experienced by Chinese patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100053
        • Jiao Juan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • meet the 1990 American College of Rheumatology (ACR) Research Classification Criteria for fibromyalgia;
  • be between the ages of 18 to 70 years.

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, and 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ba-Duan-Jin group

Ba-Duan-Jin therapy: 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.

Placebo pregabalin capsules: 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.
Other: Ba-Duan-Jin
Ba-Duan-Jin is a common form of "self-health-care" 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, previous clinical trials have demonstrated that Ba-Duan-Jin can improve sleep quality, physical health, and mental health in patients with various chronic diseases
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of the Visual Analogue Scale (VAS) for pain from baseline.
Time Frame: up to 1 week
Pain VAS, range, 0 to 100 mm, where higher scores indicated the perceived pain to be more severe.
up to 1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, week 4, week 8, and week 12.
The change of the Multidimensional Fatigue Inventory-20 (MFI-20) from baseline.
Time Frame: Baseline, week 4, week 8, and week 12.
The Multidimensional Fatigue Inventory-20 (MFI-20) measures fatigue severity. The MFI-20 total score ranges from 0 to 80, with higher scores indicate more severe fatigue.
Baseline, week 4, week 8, and week 12.
The change of the Pittsburgh Sleep Quality Index (PSQI) from baseline.
Time Frame: Baseline, week 4, week 8, and week 12.
Scores on the Pittsburgh Sleep Quality Index (PSQI) range from 0 to 21, with higher scores indicating worse sleep quality.
Baseline, week 4, week 8, and week 12.
The Beck II Depression Inventory (BDI)
Time Frame: Baseline, week 4, week 8, and week 12.
The Beck II Depression Inventory (BDI) assesses the severity of depressive symptoms. Scores range from 0 to 39, with higher scores indicate a greater degree of depression severity.
Baseline, week 4, week 8, and week 12.
The change of the Perceived Stress Scale (PSS) from baseline.
Time Frame: Baseline, week 4, week 8, and week 12.
The Perceived Stress Scale (PSS) is for measuring the perception of stress and current levels of experienced stress. Scores range from 0 to 56, with higher total score indicating a greater degree of symptom severity.
Baseline, week 4, week 8, and week 12.
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).
Week 12.
The change of the Short Form-36 Health Status Questionnaire (SF-36) from baseline.
Time Frame: Baseline, week 4, week 8, and week 12.
The Short Form-36 Health Status Questionnaire (SF-36), which measured health-related quality of life (range, 0 to 100, with higher scores indicating better perceived health status).
Baseline, week 4, week 8, and week 12.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2019

Primary Completion (Actual)

October 31, 2021

Study Completion (Actual)

October 31, 2022

Study Registration Dates

First Submitted

January 6, 2019

First Submitted That Met QC Criteria

January 6, 2019

First Posted (Actual)

January 9, 2019

Study Record Updates

Last Update Posted (Estimate)

December 6, 2022

Last Update Submitted That Met QC Criteria

December 3, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Z181100001718153

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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