Trial record 11 of 125 for:    fibromyalgia | Open Studies | Interventional Studies

Lu Eight Brocades for Treating Patients With Fibromyalgia

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor:
Collaborator:
Beijing Municipal Science & Technology Commission
Information provided by (Responsible Party):
Juan Jiao, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier:
NCT02401386
First received: March 24, 2015
Last updated: May 5, 2015
Last verified: May 2015
  Purpose

This trial aims to evaluate the effectiveness of Lu Eight Brocades(LEB) on improving quality of life in patients with fibromyalgia (FM). Sixty patients with fibromyalgia will be enrolled, and will be randomized into 2 groups with a ratio of 1:1 in this study. Thirty participants in LEB group will be asked to learn and practice LEB 30 minutes daily for 12-weeks; while the other 30 participants will be on a waiting list through 12-weeks. Seven questionnaires will be measured at baseline, 4 weeks, 8 weeks and 12 weeks (end of study), and a more 12-weeks follow-up.


Condition Intervention
Fibromyalgia
Behavioral: The Lu Eight Brocades

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Lu Eight Brocades to Improve Quality of Life in Patients With Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Guang'anmen Hospital of China Academy of Chinese Medical Sciences:

Primary Outcome Measures:
  • The change of Fibromyalgia Impact Questionnaire (FIQ) from baseline to 12 weeks [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • The change of Numerical rating scale (NRS) from baseline to 12 weeks [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ] [ Designated as safety issue: No ]
  • The change of Multidimensional Assessment Fatigue (MAF) from baseline to 12 weeks [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ] [ Designated as safety issue: No ]
  • The change of Beck depression inventory (BDI) from baseline to 12 weeks [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ] [ Designated as safety issue: No ]
  • The change of Perceived Stress Scale (PSS) from baseline to 12 weeks [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ] [ Designated as safety issue: No ]
  • The change of Pittsburgh sleep quality index (PSQI) from baseline to 12 weeks [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ] [ Designated as safety issue: No ]
  • Brain Functional Connectivity as measured by fMRI [ Time Frame: baseline, 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: May 2015
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: The Lu Eight Brocades group
Patients in this group will be assigned to start practicing LEB after being randomized .
Behavioral: The Lu Eight Brocades
LEB Intervention:The 12-week LEB program will meet in groups of about 30 persons. Each 1-hour session twice a week will include each of 8 forms of LEB movements, a review of principles, and breathing techniques in LEB. Participants will be asked to practice LEB at home for 30 minutes each day, using an instructional Digital Video Disc. The program will be taught by experienced LEB masters.
No Intervention: control group
The participants in control group will be on a waiting list through 12 weeks, then they will be asked to join LEB group for additional 12-week.

Detailed Description:

The Lu Eight Brocades(LEB) 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.

Fibromyalgia(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 LEB'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: LEB group and control group (waiting-list group). Patients will be evaluated at baseline, at 4 weeks, at 8 weeks, at 12 weeks, and a more 12-weeks follow-up. Evaluation will be based on quality of life, symptoms, standard scales of pain, degree of fatigue, depression, stress and sleep quality.All the participants will receive a half-day training, including recognizing fibromyalgia, managing chronic pain, dealing with sleep disorder and improving physical and mental health.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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 Eight Brocades 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 Eight Brocades.

    • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02401386

Contacts
Contact: Juan Jiao, M.D.,PhD +86 010-88001060 jiao.juan@hotmail.com
Contact: Yayun Zhao, M.M. +86 010-88001060 tobeornottobe2014@126.com

Locations
China, Beijing
Guang'anmen Hospital of China Academy of Chinese Medical Sciences Recruiting
Beijing, Beijing, China, 100053
Contact: Juan Jiao, M.D.,PhD    +86 010-88001060    jiao.juan@hotmail.com   
Contact: Yayun Zhao, M.M.    +86 010-88001060    tobeornottobe2014@126.com   
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

No publications provided

Responsible Party: Juan Jiao, attending physician, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT02401386     History of Changes
Other Study ID Numbers: Z141107002514094
Study First Received: March 24, 2015
Last Updated: May 5, 2015
Health Authority: China: Beijing Municipal Science and Technology Commission

Keywords provided by Guang'anmen Hospital of China Academy of Chinese Medical Sciences:
Fibromyalgia, The Lu Eight Brocades

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 05, 2015