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

• ClinicalTrials.gov Identifier: NCT03797560
• Recruitment Status: Active, not recruiting
• First Posted: January 9, 2019
• Last Update Posted: January 25, 2022
• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Information provided by (Responsible Party): Juan Jiao, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Fibromyalgia	Other: Ba-Duan-Jin; Drug: Pregabalin capsule	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 104 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparison the Treatment Effects Between Ba-Duan-Jin and Pregabalin in Patients With Fibromyalgia
• Actual Study Start Date: March 22, 2019
• Actual Primary Completion Date: October 31, 2021
• Estimated Study Completion Date: May 31, 2022

Arms and Interventions

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 Name: 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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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).
7. 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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

China, Beijing

Jiao Juan

Beijing, Beijing, China, 100053

Sponsors and Collaborators

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Yang Y, Li YT, Sun YR, Wang J, Li Y, Zhang JH, Jiao J, Jiang Q. Therapeutic Effects of Ba-Duan-Jin versus Pregabalin for Fibromyalgia Treatment: Protocol for a Randomized Controlled Trial. Rheumatol Ther. 2021 Sep;8(3):1451-1462. doi: 10.1007/s40744-021-00341-9. Epub 2021 Jul 22.

• Responsible Party: Juan Jiao, Deputy chief physician, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• ClinicalTrials.gov Identifier: NCT03797560
• Other Study ID Numbers: Z181100001718153
• First Posted: January 9, 2019
• Last Update Posted: January 25, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Keywords provided by Juan Jiao, Guang'anmen Hospital of China Academy of Chinese Medical Sciences:

Eight Brocades; Ba-Duan-Jin; Baduanjin; Qigong; Pain

Additional relevant MeSH terms:

Fibromyalgia; Myofascial Pain Syndromes; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pregabalin; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anticonvulsants; Calcium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Calcium-Regulating Hormones and Agents; Anti-Anxiety Agents; Tranquilizing Agents; Central Nervous System Depressants; Psychotropic Drugs