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

Chronic Pain Clinical Trial

— fMRI/FMEX  

Official title:

A Pilot fMRI Study of Fibromyalgia: Tai Chi Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02407665
• Other study ID #: 11552
• Status: Completed
• Phase: N/A
• First received: March 18, 2015
• Last updated: February 9, 2016
• Start date: March 2015
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Tufts Medical Center	Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Cortical Thickness as measured by fMRI		Baseline and 12-week	No
Secondary	Fibromyalgia Symptom Severity as measured by FIQR Questionnaire	FIQR	Baseline, weekly, and 12-week	No
Secondary	Widespread Pain Index as measured by Clinical Diagnostic Criteria for Fibromyalgia Questionnaire	Clinical Diagnostic Criteria for Fibromyalgia	Baseline and 12-week	No
Secondary	Depression as measured by BECK-II Questionnaire	BECK-II	Baseline and 12-week	No
Secondary	Stress/Anxiety as measured by Hospital Anxiety and Depression Scale	Hospital Anxiety and Depression Scale	Baseline and 12-week	No
Secondary	Sleep Quality as measured by PSQI Questionnaire	PSQI	baseline and 12-week	No
Secondary	Quality of Life as measured by visual analog scale and SF-36 Questionnaire	VAS, SF-36	baseline and 12-week	No
Secondary	Mindfulness as measured by Five Facet Mindfulness Questionnaire	FFMQ	baseline and 12-week	No
Secondary	Self-Efficacy as by Chronic Pain and Self Efficacy Questionnaire	Chronic Pain Self Efficacy	baseline and 12-week	No
Secondary	Quantitative Sensory Testing as measured by an Algometer	Pain threshold	baseline and 12-week	No