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Completed

NCT Number: NCT02407665

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

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

About this study

Twenty-four FM patients and 24 age matched healthy control will be recruited. All FM patients will undergo Tai Chi intervention twice weekly for 12 weeks of practice. fMRI resting state and brain structure data will be collected before and after treatment. For the healthy control group, the fMRI and structure data will only be collected once, contemporaneous with the 12 week scan for the fibromyalgia patients.

The primary outcome will be rsFC of rostral anterior cingulate cortex (rACC), a key region in descending pain modulatory system (DPMS). The secondary outcome include change of the cortical thickness changes, fibromyalgia symptom severity, widespread pain index, depression, stress/anxiety, sleep quality, and quality of life. Covariates include age, gender, body mass index, disease duration, depression, and comorbidities. Clinical outcome measurements will be collected at baseline and after 12 weeks of intervention for the fibromyalgia cohort and at a single visit for the healthy controls. The Tai Chi classes will be taught at Tufts Medical Center and the fMRI scans will be performed at Massachusetts General Hospital Martinos Center.

The project will advance science in the field of mind-body medicine for chronic pain management, both mechanistically and clinically.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.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.

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 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.

Treatment and study plan

Tai Chi

Behavioral

Each Tai Chi session will last 60 minutes and will continue twice a week for 12 weeks. Our instructors, who have extensive experience conducting Tai Chi training programs, will follow the standardized Tai Chi protocol. We will also provide the participants with printed materials on FM and the Tai Chi Mind-Body program, including Tai Chi principles, practicing techniques, and safety precautions for participants with FM

Primary outcomes

  1. Brain Resting State Functional Connectivity as measured by fMRI

    Time frame: Modulation of impaired rsFC and brain structure at 12 weeks

    rostral anterior cingulate cortex (rACC), a key region in descending pain modulatory system (DPMS)

Secondary outcomes

  1. Cortical Thickness as measured by fMRI

    Time frame: Baseline and 12-week

  2. Fibromyalgia Symptom Severity as measured by FIQR Questionnaire

    Time frame: Baseline, weekly, and 12-week

    FIQR

  3. Widespread Pain Index as measured by Clinical Diagnostic Criteria for Fibromyalgia Questionnaire

    Time frame: Baseline and 12-week

    Clinical Diagnostic Criteria for Fibromyalgia

  4. Depression as measured by BECK-II Questionnaire

    Time frame: Baseline and 12-week

    BECK-II

  5. Stress/Anxiety as measured by Hospital Anxiety and Depression Scale

    Time frame: Baseline and 12-week

    Hospital Anxiety and Depression Scale

  6. Sleep Quality as measured by PSQI Questionnaire

    Time frame: baseline and 12-week

    PSQI

  7. Quality of Life as measured by visual analog scale and SF-36 Questionnaire

    Time frame: baseline and 12-week

    VAS, SF-36

  8. Mindfulness as measured by Five Facet Mindfulness Questionnaire

    Time frame: baseline and 12-week

    FFMQ

  9. Self-Efficacy as by Chronic Pain and Self Efficacy Questionnaire

    Time frame: baseline and 12-week

    Chronic Pain Self Efficacy

  10. Quantitative Sensory Testing as measured by an Algometer

    Time frame: baseline and 12-week

    Pain threshold

Sponsors and collaborators

Lead sponsor

Tufts Medical Center

Other

Collaborators

  • Massachusetts General Hospital

Registry information

Official study title

A Pilot fMRI Study of Fibromyalgia: Tai Chi Intervention

Acronym: fMRI/FMEX

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 3, 2015
Registry last updated
Feb 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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