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

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
The Eight Brocades
Sponsored by
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia; Eight Brocades; Baduanjin; Qigong; Pain severity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

EB group

Control group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The change of Visual Analogue Scales for pain (PVAS) from baseline to 12 weeks.
The change of Fibromyalgia Impact Questionnaire (FIQ) from baseline to 12 weeks

Secondary Outcome Measures

The change of the Short Form-36 Health Status Questionnaire (SF-36) from baseline to 12 weeks
The change of Multidimensional Assessment Fatigue (MAF) from baseline to 12 weeks
The change of Beck depression inventory (BDI) from baseline to 12 weeks
The change of Perceived Stress Scale (PSS) from baseline to 12 weeks
The change of Pittsburgh sleep quality index (PSQI) from baseline to 12 weeks

Full Information

First Posted
March 24, 2015
Last Updated
January 18, 2018
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborators
Beijing Municipal Science & Technology Commission
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1. Study Identification

Unique Protocol Identification Number
NCT02401386
Brief Title
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

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
March 2015 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborators
Beijing Municipal Science & Technology Commission

4. Oversight

Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia; Eight Brocades; Baduanjin; Qigong; Pain severity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EB group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
The Eight Brocades
Intervention Description
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.
Primary Outcome Measure Information:
Title
The change of Visual Analogue Scales for pain (PVAS) from baseline to 12 weeks.
Time Frame
baseline, 4 weeks, 8 weeks, 12 weeks
Title
The change of Fibromyalgia Impact Questionnaire (FIQ) from baseline to 12 weeks
Time Frame
baseline, 4 weeks, 8 weeks, 12 weeks
Secondary Outcome Measure Information:
Title
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
Title
The change of Multidimensional Assessment Fatigue (MAF) from baseline to 12 weeks
Time Frame
baseline, 4 weeks, 8 weeks, 12 weeks
Title
The change of Beck depression inventory (BDI) from baseline to 12 weeks
Time Frame
baseline, 4 weeks, 8 weeks, 12 weeks
Title
The change of Perceived Stress Scale (PSS) from baseline to 12 weeks
Time Frame
baseline, 4 weeks, 8 weeks, 12 weeks
Title
The change of Pittsburgh sleep quality index (PSQI) from baseline to 12 weeks
Time Frame
baseline, 4 weeks, 8 weeks, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Jiao, M.D.,PhD
Organizational Affiliation
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China

12. IPD Sharing Statement

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

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