Clinical Trials Directory

Trials / Completed

CompletedNCT02407665

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

A Pilot fMRI Study of Fibromyalgia: Tai Chi Intervention

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
55 (actual)
Sponsor
Tufts Medical Center · Academic / Other
Sex
All
Age
21 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
BEHAVIORALTai ChiEach 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

Timeline

Start date
2015-03-01
Primary completion
2015-12-01
Completion
2015-12-01
First posted
2015-04-03
Last updated
2016-02-10

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02407665. Inclusion in this directory is not an endorsement.