Eight Brocades (Ba Duan Jin) for Treating Patients With Fibromyalgia

• ClinicalTrials.gov Identifier: NCT02401386
• Recruitment Status: Completed
• First Posted: March 27, 2015
• Last Update Posted: January 23, 2018
• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Collaborator: Beijing Municipal Science & Technology Commission
• Information provided by (Responsible Party): Juan Jiao, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study Description

Brief Summary:

In this randomized, usual therapy-controlled study, 62 patients with fibromyalgi (FM) were recruited with a ratio of 1:1. Trained and guided by Eight Brocades (EB) certified physicians, participant practiced EB one hour, twice a week for 12 weeks. Evaluation will be based on standard scales of pain, FM symptoms severity, degree of fatigue, depression, sleep quality and quality of life.

Condition or disease	Intervention/treatment	Phase
Fibromyalgia	Behavioral: The Eight Brocades	Not Applicable

Detailed Description:

The EB, also written as Ba Duan Jin, or Baduanjin, or Eight-Section Brocade, is a set of Qigong exercises that originated in China and date back thousands of years. It is a mind-body practice that combines meditation with slow, gentle, graceful movements, as well as deep breathing and relaxation, to move vital energy (or qi) throughout the body and is practiced as a rehabilitation exercise for various kinds of diseases. It is considered a complex, multicomponent intervention that integrates physical, psychosocial, emotional, spiritual, and behavioral elements. Participants in the EB group received a modified EB adapted by Chinese Medicine Master Zhi-zheng Lu, which was added several joint exercise movements to the traditional EB forms to specifically tailor it for patients with rheumatic diseases.

FM is a common and complex clinical syndrome characterized by chronic and widespread musculoskeletal pain, fatigue, sleep disturbance, and physical and psychological impairment. Evidence-based guidelines suggest that exercise is beneficial for FM and has been advocated as a core component of its treatment. Because of EB's mind-body attributes and it is easy to learn, we assume that it could be well suited for the treatment of FM.

Patients enrolled in this trial will be randomly allocated into one of two groups: EB group and usual therapy-controlled group. Patients will be evaluated at baseline, at week 4, 8 and 12. The primary outcome measure was a Visual Analogue Scales for pain (PVAS). Secondary outcome measures included the following: the Revised FM Impact Questionnaire (FIQR), the Multidimensional Assessment of Fatigue (MAF), the Pittsburgh Sleep Quality Index (PSQI), the Beck Depression Inventory (BDI), the Perceived Stress Scale (PSS), and the Tender Points Count (TPC).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 62 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized Controlled Trial of Eight Brocades (Ba Duan Jin) to Improve Quality of Life in Patients With Fibromyalgia
• Actual Study Start Date: March 2015
• Actual Primary Completion Date: February 2017
• Actual Study Completion Date: August 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: EB group; Trained and guided by EB certified physicians, patients in EB group received closely supervised, group-format EB program and practiced EB for one hour, twice weekly for 12 weeks in the Guang'anmen Hospital.	Behavioral: The Eight Brocades; Patients received closely supervised, group-format EB program and practiced EB revised by Chinese Medicine Master Zhi-zheng Lu for one hour, twice weekly for 12 weeksmovements, a review of principles, and breathing techniques in EB. Participants will be asked to practice EB at home for at least 16 minutes each day which is how long it takes to complete an EB exercise, using an instructional Digital Video Disc. The program will be taught by experienced EB masters.
No Intervention: Control group; The participants in usual therapy-controlled group will stay on their previous treatment through 12 weeks. As compensation, they will be invited to receive LEB training for 12 weeks after the end of the study.

Outcome Measures

Primary Outcome Measures :

1. The change of Visual Analogue Scales for pain (PVAS) from baseline to 12 weeks. [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ]
2. The change of Fibromyalgia Impact Questionnaire (FIQ) from baseline to 12 weeks [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ]

Secondary Outcome Measures :

1. The change of the Short Form-36 Health Status Questionnaire (SF-36) from baseline to 12 weeks [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ]
2. The change of Multidimensional Assessment Fatigue (MAF) from baseline to 12 weeks [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ]
3. The change of Beck depression inventory (BDI) from baseline to 12 weeks [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ]
4. The change of Perceived Stress Scale (PSS) from baseline to 12 weeks [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ]
5. The change of Pittsburgh sleep quality index (PSQI) from baseline to 12 weeks [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ]

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:

• • Age 18 years or older.

  • Fulfills the American College of Rheumatology (ACR) 1990 classification criteria for FM.
  • On a stable variety and dosage of pharmacologic for FM ≥4 weeks

Exclusion Criteria:

• • Prior experience with EB or other similar types of Complementary and Alternative Medicine in the past 1 year such as Qi gong, Tai Chi and yoga since these share some of the principles of EB.

  • Dementia, cancer, or other serious medical conditions limiting ability to participate in the Eight Brocades or strength training, as determined by the study physicians.
  • Any other diagnosed medical condition known to contribute to FM symptomatology that is not under adequate control for the study period such as thyroid disease, inflammatory arthritis, systemic lupus erythematosus, rheumatoid arthritis, myositis, vasculitis or Sjogren's syndrome.
  • Positive urine pregnancy test at baseline or planning pregnancy within the study period.
  • Reside >70 miles from the research site.

Contacts and Locations

Locations

China, Beijing

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Beijing, Beijing, China, 100053

Sponsors and Collaborators

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Beijing Municipal Science & Technology Commission

Investigators

• Principal Investigator: Juan Jiao, M.D.,PhD; Guang'anmen Hospital of China Academy of Chinese Medical Sciences

More Information

• Responsible Party: Juan Jiao, Associate chief physician, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• ClinicalTrials.gov Identifier: NCT02401386
• Other Study ID Numbers: Z141107002514094
• First Posted: March 27, 2015
• Last Update Posted: January 23, 2018
• Last Verified: January 2018

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

Fibromyalgia; Eight Brocades; Baduanjin; Qigong; Pain severity

Additional relevant MeSH terms:

Fibromyalgia; Myofascial Pain Syndromes; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases