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Tai Chi Intervention and Brain Imaging Study Among Fibromyalgia Patients and Healthy Controls (fMRI/FMEX)

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ClinicalTrials.gov Identifier: NCT02407665
Recruitment Status : Completed
First Posted : April 3, 2015
Last Update Posted : February 10, 2016
Sponsor:
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
Tufts Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Chronic Pain Behavioral: Tai Chi Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot fMRI Study of Fibromyalgia: Tai Chi Intervention
Study Start Date : March 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Experimental: Tai Chi
Participants who practice Tai Chi 2X/week for 12-weeks
Behavioral: Tai Chi
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

No Intervention: Healthy Control
24 healthy controls



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02407665


Locations
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United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts Medical Center
Massachusetts General Hospital
Investigators
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Principal Investigator: Chenchen Wang, MD, MSc Tufts University School of Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT02407665    
Other Study ID Numbers: 11552
First Posted: April 3, 2015    Key Record Dates
Last Update Posted: February 10, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Tufts Medical Center:
Tai Chi
fMRI
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Chronic Pain
Pain
Neurologic Manifestations
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases