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

NCT03797560 | Completed

• 1 other identifier: Z181100001718153
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The change of the Visual Analogue Scale (VAS) for pain from baseline.

  Pain VAS, range, 0 to 100 mm, where higher scores indicated the perceived pain to be more severe.

  up to 1 week

Secondary Outcomes (7)

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

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

• The change of the Multidimensional Fatigue Inventory-20 (MFI-20) from baseline.

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

• The change of the Pittsburgh Sleep Quality Index (PSQI) from baseline.

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

• The Beck II Depression Inventory (BDI)

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

• The change of the Perceived Stress Scale (PSS) from baseline.

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

Study Arms (2)

Ba-Duan-Jin group

EXPERIMENTAL

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

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

Interventions

Ba-Duan-Jin OTHER

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

Also known as: Baduanjin; Eight Brocades; Eight-Section Brocade

Ba-Duan-Jin group

Pregabalin capsule DRUG

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

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

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, 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.

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

Study Sites (1)

Jiao Juan

Beijing, Beijing Municipality, 100053, China

Location

Related Publications (1)

• 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.

  PMID: 34292537 BACKGROUND

Related Links

• In this article the study protocol and background are described

MeSH Terms

Conditions

Fibromyalgia; Pain

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

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

Study Record Dates

• First Submitted: January 6, 2019
• First Posted: January 9, 2019
• Study Start: March 22, 2019
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2022
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)