Clinical trial NCT00515008: Tai Chi Mind-Body Therapy for Fibromyalgia
Official title: Tai Chi Mind-Body Therapy for Fibromyalgia: a Pilot Single-Blind Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: American College of Rheumatology Research and Education Foundation
First posted: 2007-08-13
Enrollment: 66
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean Change From Baseline of Fibromyalgia Impact Questionnaire Score
timeFrame: wks 12
Secondary outcomes:
measure: Mean Change From Baseline of VAS Physicians' Global Assessment of Fibromyalgia Severity
timeFrame: Wks 12
measure: Mean Change From Baseline of Patient's Global Assessment Score
timeFrame: 12 weeks
measure: Mean Change From Baseline PSQI Score
timeFrame: 12 weeks
measure: Mean Change From Baseline of 6-Minute Walk Test
timeFrame: 12 weeks
measure: Mean Change From Baseline SF-36 Score Physical Component
timeFrame: 12 weeks
measure: Mean Change From Baseline SF-36 Score Mental Component
timeFrame: 12 weeks
measure: Mean Change From Baseline CES-D Score
timeFrame: 12 weeks
measure: Mean Change From Baseline CPSS Score
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center, Division of Rheumatology
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Chenchen Wang, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang C, Collet JP, Lau J. The effect of Tai Chi on health outcomes in patients with chronic conditions: a systematic review. Arch Intern Med. 2004 Mar 8;164(5):493-501. doi: 10.1001/archinte.164.5.493.
citation: Wang C, Roubenoff R, Lau J, Kalish R, Schmid CH, Tighiouart H, Rones R, Hibberd PL. Effect of Tai Chi in adults with rheumatoid arthritis. Rheumatology (Oxford). 2005 May;44(5):685-7. doi: 10.1093/rheumatology/keh572. Epub 2005 Mar 1. No abstract available.
citation: Wang C. Tai Chi improves pain and functional status in adults with rheumatoid arthritis: results of a pilot single-blinded randomized controlled trial. Med Sport Sci. 2008;52:218-229. doi: 10.1159/000134302.
citation: Wang C, Schmid CH, Rones R, Kalish R, Yinh J, Goldenberg DL, Lee Y, McAlindon T. A randomized trial of tai chi for fibromyalgia. N Engl J Med. 2010 Aug 19;363(8):743-54. doi: 10.1056/NEJMoa0912611.