Fibromyalgia Clinical Trial
Official title:
Tai Chi Mind-Body Therapy for Fibromyalgia: a Pilot Single-Blind Randomized Controlled Trial.
The purpose of this study is to obtain preliminary data on the effects of Tai Chi on musculoskeletal pain, fatigue, sleep quality, psychological distress, physical performance,and health status in 60 patients with fibromyalgia.
Fibromyalgia (FM) is a common, complex chronic condition marked by diffuse musculoskeletal
pain, fatigue, functional impairment, disability, and psychological distress that affects
6-10 million people in the United States (US). There are currently no satisfactory
pharmacological or non-pharmacological treatments for FM. New cost-effective strategies that
reduce musculoskeletal pain and improve emotional and physical functioning as well as
quality of life in people with FM are urgently needed.
Tai Chi is a traditional Chinese discipline with both physical and mental components that
appears to benefit a variety of chronic conditions. The physical component provides exercise
that is consistent with that recommended for FM (muscle conditioning and aerobic
cardiovascular exercise), while the mental component has the potential to improve
psychological well-being. These effects are especially pertinent for the treatment of
individuals with FM.
This is a pilot randomized controlled trial of Tai Chi for fibromyalgia. We plan to enroll
60 patients with fibromyalgia over a two year period. Participants are randomized to either
a Tai Chi program or an attention control intervention. Assessments are performed at
baseline, week 12 and week 24. This study will provide preliminary data on the potential
acceptability and safety of Tai Chi for FM and will help guide the design of a future
large-scale study of the efficacy of this alternative therapy.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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