Tufts Medical Center
Boston, Massachusetts, 02111, United States
NCT Number: NCT02407665
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.
Looking for future studies?
Notify Me21 year and older
All sexes
Interventional
Not applicable
Boston, Massachusetts, 02111, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Modulation of impaired rsFC and brain structure at 12 weeks
rostral anterior cingulate cortex (rACC), a key region in descending pain modulatory system (DPMS)
Time frame: Baseline and 12-week
Time frame: Baseline, weekly, and 12-week
FIQR
Time frame: Baseline and 12-week
Clinical Diagnostic Criteria for Fibromyalgia
Time frame: Baseline and 12-week
BECK-II
Time frame: Baseline and 12-week
Hospital Anxiety and Depression Scale
Time frame: baseline and 12-week
PSQI
Time frame: baseline and 12-week
VAS, SF-36
Time frame: baseline and 12-week
FFMQ
Time frame: baseline and 12-week
Chronic Pain Self Efficacy
Time frame: baseline and 12-week
Pain threshold
Tufts Medical Center
Other
A Pilot fMRI Study of Fibromyalgia: Tai Chi Intervention
Acronym: fMRI/FMEX
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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