Trial record 35 of 125 for:    fibromyalgia | Open Studies | Interventional Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Tufts Medical Center
Massachusetts General Hospital
Information provided by (Responsible Party):
Tufts Medical Center Identifier:
First received: March 18, 2015
Last updated: March 30, 2015
Last verified: March 2015

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 Intervention
Chronic Pain
Behavioral: Tai Chi

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot fMRI Study of Fibromyalgia: Tai Chi Intervention

Resource links provided by NLM:

Further study details as provided by Tufts Medical Center:

Primary Outcome Measures:
  • Brain Resting State Functional Connectivity as measured by fMRI [ Time Frame: Modulation of impaired rsFC and brain structure at 12 weeks ] [ Designated as safety issue: No ]
    rostral anterior cingulate cortex (rACC), a key region in descending pain modulatory system (DPMS)

Secondary Outcome Measures:
  • Cortical Thickness as measured by fMRI [ Time Frame: Baseline and 12-week ] [ Designated as safety issue: No ]
  • Fibromyalgia Symptom Severity as measured by FIQR Questionnaire [ Time Frame: Baseline, weekly, and 12-week ] [ Designated as safety issue: No ]

  • Widespread Pain Index as measured by Clinical Diagnostic Criteria for Fibromyalgia Questionnaire [ Time Frame: Baseline and 12-week ] [ Designated as safety issue: No ]
    Clinical Diagnostic Criteria for Fibromyalgia

  • Depression as measured by BECK-II Questionnaire [ Time Frame: Baseline and 12-week ] [ Designated as safety issue: No ]

  • stress/anxiety as measured by Hospital Anxiety and Depression Scale [ Time Frame: Baseline and 12-week ] [ Designated as safety issue: No ]
    Hospital Anxiety and Depression Scale

  • sleep quality as measured by PSQI Questionnaire [ Time Frame: baseline and 12-week ] [ Designated as safety issue: No ]

  • quality of life as measured by visual analog scale and SF-36 Questionnaire [ Time Frame: baseline and 12-week ] [ Designated as safety issue: No ]
    VAS, SF-36

  • Mindfulness as measured by Five Facet Mindfulness Questionnaire [ Time Frame: baseline and 12-week ] [ Designated as safety issue: No ]

  • Self-Efficacy as by Chronic Pain and Self Efficacy Questionnaire [ Time Frame: baseline and 12-week ] [ Designated as safety issue: No ]
    Chronic Pain Self Efficacy

  • Quantitative Sensory Testing as measured by an Algometer [ Time Frame: baseline and 12-week ] [ Designated as safety issue: No ]
    Pain threshold

Estimated Enrollment: 48
Study Start Date: March 2015
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02407665

Contact: Emily A Wolcott, BA 617-636-8682
Contact: Anna Schmid, BA 617-636-8682

United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Emily Wolcott, BA    617-636-8682   
Contact: Anna Schmid    617-636-8682   
Sponsors and Collaborators
Tufts Medical Center
Massachusetts General Hospital
Principal Investigator: Chenchen Wang, MD, MSc Tufts University School of Medicine
  More Information

No publications provided

Responsible Party: Tufts Medical Center Identifier: NCT02407665     History of Changes
Other Study ID Numbers: 11552
Study First Received: March 18, 2015
Last Updated: March 30, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Tufts Medical Center:
Tai Chi

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Chronic Pain
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Rheumatic Diseases
Signs and Symptoms processed this record on October 09, 2015