Fibromyalgia
Conditions
Keywords
Fibromyalgia, Tai Chi, mind-body exercise, aerobic exercise, exercise, pain
Brief summary
The investigators will conduct a large randomized controlled trial comparing the effectiveness of Tai Chi mind-body exercise and standard-of-care aerobic exercise for fibromyalgia. In addition, the investigators will determine the optimal frequency and duration of a Tai Chi intervention for short and long-term effectiveness.
Detailed description
Fibromyalgia (FM) is a chronic musculoskeletal pain syndrome that causes substantial physical and psychological impairment and costs over $25 billion annually. Current pharmacological therapies may be expensive, cause serious adverse effects, and fail to effectively improve pain and function. Finding new and effective non-pharmacological treatments for FM patients is urgently needed. We propose to conduct the first comparative effectiveness trial of Tai Chi vs. aerobic exercise (a recommended component of the current standard of care) and to evaluate effectiveness under different Tai Chi dosing schedules in a large FM population. We aim to (1) demonstrate that, compared to aerobic exercise, Tai Chi is a more effective intervention for managing the pain and improving the functional limitations that impact quality of life for FM patients, and 2) determine the optimal frequency and duration of a supervised Tai Chi intervention in relation to short and long-term effectiveness. To achieve this goal, we will conduct a single-blind, randomized controlled trial of Tai Chi vs. aerobic exercise in 216 patients who meet the American College of Rheumatology criteria for FM. Patients will be randomized to one of four Tai Chi intervention groups: 12 or 24 weeks of supervised Tai Chi given once or twice per week, or a supervised aerobic exercise control: 2x/week for 24 weeks. All groups will have a 52-week follow-up. The primary outcome will be the FM Impact Questionnaire total score at 24 weeks. Secondary outcomes include the measures of widespread pain, functional performance, psychological functioning, self-efficacy, sleep quality, and quality of life at 12, 24, and 52 weeks. Successful completion of the proposed study will determine the ideal regimen of Tai Chi and demonstrate that Tai Chi can be a simple, effective, and durable treatment for this therapeutically challenging disorder.
Interventions
BEHAVIORALLower frequency, shorter period of Tai Chi
12 weeks of supervised Tai Chi classes, 1x/week
BEHAVIORALHigher frequency, shorter period of Tai Chi
12 weeks of supervised Tai Chi classes, 2x/week
BEHAVIORALShorter frequency, longer period of Tai Chi
24 weeks of supervised Tai Chi classes, 1x/week
BEHAVIORALHigher frequency, longer period of Tai Chi
24 weeks of supervised Tai Chi classes, 2x/week
BEHAVIORALAerobic Exercise Training
24 weeks of supervised aerobic exercise training, 2x/week
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
Tufts Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 21 years or older. * Fulfills the American College of Rheumatology (ACR) 1990 classification 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.27 * Fulfills the ACR 2010 diagnostic criteria for FM: (WPI ≥7 AND SS ≥5) OR (WPI 3-6 AND SS ≥9) and does not have a disorder that would otherwise explain the pain28 * Willing to complete the 12-week or 24-week study, including once or twice-a-week exercise sessions. * Willing to abstain from Tai Chi or other new formalized exercise programs until completion of the study if randomized to the Aerobic Exercise. * Willing to abstain from Aerobic Exercise or other new formalized exercise programs until completion of the study if randomized to Tai Chi
Exclusion criteria
* Prior experience with Tai Chi or other similar types of Complementary and Alternative Medicine in the past 1 year such as Qi gong and yoga since these share some of the principles of Tai Chi. * Dementia, neurological disease, cancer, cardiovascular disease, pulmonary disease, metabolic disease, renal disease, liver disease, or other serious medical conditions limiting ability to participate in the Tai Chi or Aerobic Exercise programs, 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. * Inability to pass the Mini-Mental Status examination (with a score below 24) 29 * Enrollment in any other clinical trial within the last 30 days * Plan to permanently relocate from the region during the trial period * Positive urine pregnancy test at baseline or planning pregnancy within the study period * Not English-Speaking: English is the only language to be used during the exercise training program. Our self-reported outcome measures are obtained from validated English-version questionnaires. In addition, using other languages would likely require separate classes, recruitment and instructors which are beyond our current study scope
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fibromyalgia Impact Questionnaire (FIQ) from baseline to 24 weeks | Week 0, Week 24 | Overall severity of FM, intensity of pain, physical function, fatigue, morning tiredness, depression, anxiety, job difficulty, and overall well-being |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FM Symptom Severity Scale | Week 0, Week 12, Week 24, Week 52 | FM symptoms |
| Body Mass Index (BMI) | Week 0, Week 12, Week 24, Week 52 | General health |
| Medical Outcome Study Short Form 36 (SF-36) | Week 0, Week 12, Week 24, Week 52 | General health/functional status |
| Patient Global Assessment | Week 0, Week 12, Week 24, Week 52 | General health/functional status |
| The Beck Depression Inventory II | Week 0, Week 12, Week 24, Week 52 | Depression |
| The Chronic Pain Self-Efficacy Scale (CPSS) | Week 0, Week 12, Week 24, Week 52 | Chronic pain |
| The Pittsburg Sleep Quality Index (PSQI) | Week 0, Week 12, Week 24, Week 52 | Sleep quality |
| Change in Fibromyalgia Impact Questionnaire at follow-up | Week 0, Week 12, Week 52 | Overall severity of FM, intensity of pain, physical function, fatigue, morning tiredness, depression, anxiety, job difficulty, and overall well-being |
| 6-Minute Walk | Week 0, Week 12, Week 24, Week 52 | Walking ability and Endurance |
| The Chair Stand Test | Week 0, Week 12, Week 24, Week 52 | Physical functioning |
| The brief Outcome Expectation Scale (OES) | Week 0, Week 12, Week 24, Week 52 | Outcome expectations |
| Health Assessment Questionnaire (HAQ) | Week 0, Week 12, Week 24, Week 52 | Healthcare cost and utilization |
| PROMIS Health Assessment Questionnaire (HAQ) | Week 0, Week 12, Week 24, Week 52 | Health status |
| Muscle Strength/Power and Balance | Week 0, Week 12, Week 24, Week 52 | Physical functioning as assessed by muscle strength and power, and balance |
| CHAMPS Activities Questionnaire for Older Adults | Week 0, Week 12, Week 24, Week 52 | Activity levels |
| The Sleep Quality Numeric Rating Scale (NRS) | Week 0, Week 12, Week 24, Week 52 | Sleep quality |
Countries
United States
Outcome results
None listed