Clinical trial NCT02407665: Tai Chi Intervention and Brain Imaging Study Among Fibromyalgia Patients and Healthy Controls
Official title: A Pilot fMRI Study of Fibromyalgia: Tai Chi Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Chronic Pain
Keywords: Tai Chi
fMRI
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
First posted: 2015-04-03
Enrollment: 55
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Brain Resting State Functional Connectivity as measured by fMRI
timeFrame: Modulation of impaired rsFC and brain structure at 12 weeks
Secondary outcomes:
measure: Cortical Thickness as measured by fMRI
timeFrame: Baseline and 12-week
measure: Fibromyalgia Symptom Severity as measured by FIQR Questionnaire
timeFrame: Baseline, weekly, and 12-week
measure: Widespread Pain Index as measured by Clinical Diagnostic Criteria for Fibromyalgia Questionnaire
timeFrame: Baseline and 12-week
measure: Depression as measured by BECK-II Questionnaire
timeFrame: Baseline and 12-week
measure: Stress/Anxiety as measured by Hospital Anxiety and Depression Scale
timeFrame: Baseline and 12-week
measure: Sleep Quality as measured by PSQI Questionnaire
timeFrame: baseline and 12-week
measure: Quality of Life as measured by visual analog scale and SF-36 Questionnaire
timeFrame: baseline and 12-week
measure: Mindfulness as measured by Five Facet Mindfulness Questionnaire
timeFrame: baseline and 12-week
measure: Self-Efficacy as by Chronic Pain and Self Efficacy Questionnaire
timeFrame: baseline and 12-week
measure: Quantitative Sensory Testing as measured by an Algometer
timeFrame: baseline and 12-week
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
affiliation: Tufts University School of Medicine
name: Chenchen Wang, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.