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

NCT ID: NCT02407665

Last Updated: 2016-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2015-12-31

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.

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.

Conditions

Fibromyalgia; Chronic Pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tai Chi

Participants who practice Tai Chi 2X/week for 12-weeks

Group Type: EXPERIMENTAL

Tai Chi

Intervention Type: 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

Healthy Control

24 healthy controls

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: collaborator

Tufts Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chenchen Wang, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Tufts University School of Medicine

Locations

Tufts Medical Center

Boston, Massachusetts, United States

Countries

United States

References

Kong J, Huang Y, Liu J, Yu S, Ming C, Chen H, Wilson G, Harvey WF, Li W, Wang C. Altered functional connectivity between hypothalamus and limbic system in fibromyalgia. Mol Brain. 2021 Jan 20;14(1):17. doi: 10.1186/s13041-020-00705-2.

Reference Type: DERIVED

PMID: 33472674 (View on PubMed)

Other Identifiers

11552

Identifier Type: -

Identifier Source: org_study_id