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

NCT02407665 | Completed

• 1 other identifier: 11552
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia; Chronic Pain

Keywords

Tai Chi; fMRI

Outcome Measures

Primary Outcomes (1)

• Brain Resting State Functional Connectivity as measured by fMRI

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

  Modulation of impaired rsFC and brain structure at 12 weeks

Secondary Outcomes (10)

• Cortical Thickness as measured by fMRI

  Baseline and 12-week

• Fibromyalgia Symptom Severity as measured by FIQR Questionnaire

  Baseline, weekly, and 12-week

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

  Baseline and 12-week

• Depression as measured by BECK-II Questionnaire

  Baseline and 12-week

• Stress/Anxiety as measured by Hospital Anxiety and Depression Scale

  Baseline and 12-week

Study Arms (2)

Tai Chi

EXPERIMENTAL

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

Behavioral: Tai Chi

Healthy Control

NO INTERVENTION

24 healthy controls

Interventions

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

Tai Chi

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Tufts Medical Center: lead
• Massachusetts General Hospital: collaborator

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Related Publications (1)

• 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.

  PMID: 33472674 DERIVED

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Chenchen Wang, MD, MSc

  Tufts University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2015
• First Posted: April 3, 2015
• Study Start: March 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 10, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)