Tai Chi Mind-Body Therapy for 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.

Inclusion Criteria:

- Age 21 or older

- Fulfills the American College of Rheumatology (ACR) 1990 diagnostic criteria for FM.
(1) a history of widespread musculoskeletal pain on the right and left sides of the
body as well as above and below the waist for a minimum duration of 3 months, and (2)
pain in 11 or more of 18 specific tender points with moderate or greater tenderness
reported upon digital palpation.

- Physically able to participate in both the Tai Chi and stretching and education
programs according to their primary care physician.

- Willing to complete the 12-week study, including twice-a-week Tai Chi or stretching
and education sessions

Exclusion Criteria

- Prior experience with Tai Chi or other similar types of Complementary and Alternative
Medicine in the past 6 months such as Qi gong and yoga since these share some of the
principles of Tai Chi

- Any health condition limiting the ability to participate as determined by a primary
care physician

- Any other diagnosed medical condition that is known to contribute to FM
symptomatology that is not under adequate control or cannot be expected to remain
under adequate control for the study period such as thyroid disease, inflammatory
arthritis, scleroderma, systemic lupus erythematosus, systemic sclerosis, rheumatoid
arthritis, myositis and vasculitis or Sjogren's syndrome

- Not English-Speaking

- Positive pregnancy test or planning pregnancy within the study period

- Inability to pass the Mini-Mental Status examination (score below 24)

- Enrollment in any other clinical trial within the last 30 days

- Plan to permanently relocate from the region during the trial period