Tai Chi Intervention and Brain Imaging Study Among Fibromyalgia Patients and Healthy Controls

Completed · Not applicable

Conditions studied: Fibromyalgia, Chronic Pain

In brief

This exploratory study proposal is the first pilot brain imaging study to determine if Tai Chi can modulate brain resting state functional connectivity (rsFC) and brain morphometry among fibromyalgia (FM) patients and healthy controls.

Key facts

Study ID

NCT02407665

Run by

Tufts Medical Center

People needed

55

Starts

2015-03-01

Expected to finish

2015-12-01

Last updated by the study team

2016-02-10

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.22
• 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 pain23
• Willing to complete a 12-week, twice-a-week Tai Chi exercise program.
• Willing to abstain from Aerobic Exercise or other new formalized exercise programs until completion of the study.
• Willing to undergo MRI at baseline and follow-up.

You may not qualify if…

• 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 programs, as determined by the study physicians.
• Any other diagnosed medical condition known to contribute to FM symptomatology, such as thyroid disease, inflammatory arthritis, systemic lupus erythematosis, rheumatoid arthritis, myositis, vasculitis or Sjogren's syndrome.
• Inability to pass the Physical Activity Readiness Questionnaire (PAR-Q)
• Inability to pass the Mini-Mental Status examination (with a score below 24)24 Enrollment in any other clinical trial within the last 30 days
• Plan to permanently relocate from the region during the trial period
• Presence of any contraindications to fMRI scanning. Including but not limited to: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy, weight >300 lbs
• Non-English Speaking.

Where it is running

• Tufts Medical Center — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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