Clinical Trial: Lu Eight Brocades for Treating Patients With Fibromyalgia

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Randomized Controlled Trial of Lu Eight Brocades to Improve Quality of Life in Patients With Fibromyalgia

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Current Primary Outcome: The change of Fibromyalgia Impact Questionnaire (FIQ) from baseline to 12 weeks [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]
  • The change of Numerical rating scale (NRS) from baseline to 12 weeks [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ]
  • The change of Multidimensional Assessment Fatigue (MAF) from baseline to 12 weeks [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ]
  • The change of Beck depression inventory (BDI) from baseline to 12 weeks [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ]
  • The change of Perceived Stress Scale (PSS) from baseline to 12 weeks [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ]
  • The change of Pittsburgh sleep quality index (PSQI) from baseline to 12 weeks [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ]
  • Brain Functional Connectivity as measured by fMRI [ Time Frame: baseline, 12 weeks ]


Original Secondary Outcome:

  • 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 ]
  • The change of Numerial rating scale (NRS) from baseline to 12 weeks [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ]
  • The change of Multidimensional Assessment Fatigue (MAF) from baseline to 12 weeks [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ]
  • The change of Beck depression inventory (BDI) from baseline to 12 weeks [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ]
  • The change of Perceived Stress Scale (PSS) from baseline to 12 weeks [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ]
  • The change of Pittsburgh sleep quality index (PSQI) from baseline to 12 weeks [ Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks ]


Information By: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Dates:
Date Received: March 24, 2015
Date Started: May 2015
Date Completion: September 2017
Last Updated: February 22, 2017
Last Verified: June 2016