Clinical trial NCT02401386: Eight Brocades (Ba Duan Jin) for Treating Patients With Fibromyalgia
Official title: A Randomized Controlled Trial of Eight Brocades (Ba Duan Jin) to Improve Quality of Life in Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia; Eight Brocades; Baduanjin; Qigong; Pain severity
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Beijing Municipal Science & Technology Commission
First posted: 2015-03-27
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility 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.

Primary outcomes:
measure: The change of Visual Analogue Scales for pain (PVAS) from baseline to 12 weeks.
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks
measure: The change of Fibromyalgia Impact Questionnaire (FIQ) from baseline to 12 weeks
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks
Secondary outcomes:
measure: The change of the Short Form-36 Health Status Questionnaire (SF-36) from baseline to 12 weeks
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks
measure: The change of Multidimensional Assessment Fatigue (MAF) from baseline to 12 weeks
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks
measure: The change of Beck depression inventory (BDI) from baseline to 12 weeks
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks
measure: The change of Perceived Stress Scale (PSS) from baseline to 12 weeks
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks
measure: The change of Pittsburgh sleep quality index (PSQI) from baseline to 12 weeks
timeFrame: baseline, 4 weeks, 8 weeks, 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
state: Beijing
Study officials:
affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Juan Jiao, M.D.,PhD
role: PRINCIPAL_INVESTIGATOR
References: