- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02407665
Tai Chi Intervention and Brain Imaging Study Among Fibromyalgia Patients and Healthy Controls (fMRI/FMEX)
A Pilot fMRI Study of Fibromyalgia: Tai Chi Intervention
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02111
- Tufts Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tai Chi
Participants who practice Tai Chi 2X/week for 12-weeks
|
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
|
No Intervention: Healthy Control
24 healthy controls
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brain Resting State Functional Connectivity as measured by fMRI
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)
|
Modulation of impaired rsFC and brain structure at 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cortical Thickness as measured by fMRI
Time Frame: Baseline and 12-week
|
Baseline and 12-week
|
|
Fibromyalgia Symptom Severity as measured by FIQR Questionnaire
Time Frame: Baseline, weekly, and 12-week
|
FIQR
|
Baseline, weekly, and 12-week
|
Widespread Pain Index as measured by Clinical Diagnostic Criteria for Fibromyalgia Questionnaire
Time Frame: Baseline and 12-week
|
Clinical Diagnostic Criteria for Fibromyalgia
|
Baseline and 12-week
|
Depression as measured by BECK-II Questionnaire
Time Frame: Baseline and 12-week
|
BECK-II
|
Baseline and 12-week
|
Stress/Anxiety as measured by Hospital Anxiety and Depression Scale
Time Frame: Baseline and 12-week
|
Hospital Anxiety and Depression Scale
|
Baseline and 12-week
|
Sleep Quality as measured by PSQI Questionnaire
Time Frame: baseline and 12-week
|
PSQI
|
baseline and 12-week
|
Quality of Life as measured by visual analog scale and SF-36 Questionnaire
Time Frame: baseline and 12-week
|
VAS, SF-36
|
baseline and 12-week
|
Mindfulness as measured by Five Facet Mindfulness Questionnaire
Time Frame: baseline and 12-week
|
FFMQ
|
baseline and 12-week
|
Self-Efficacy as by Chronic Pain and Self Efficacy Questionnaire
Time Frame: baseline and 12-week
|
Chronic Pain Self Efficacy
|
baseline and 12-week
|
Quantitative Sensory Testing as measured by an Algometer
Time Frame: baseline and 12-week
|
Pain threshold
|
baseline and 12-week
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Chenchen Wang, MD, MSc, Tufts University School of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11552
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Pain
-
Pain ConcernThe Thistle Foundation; Health and Social Care Alliance Scotland (the ALLIANCE) and other collaboratorsCompletedChronic Pain | Chronic Pain Syndrome | Chronic Pain, Widespread | Chronic Pain Due to Trauma | Chronic Pain Due to Malignancy (Finding) | Chronic Pain Due to Injury | Chronic Pain Post-Procedural | Chronic Pain HipUnited Kingdom
-
Consorci Sanitari de l'Alt Penedès i GarrafRecruitingChronic Post Operative Pain | Chronic Post-surgical Pain | Chronic Knee PainSpain
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
University of Alabama, TuscaloosaPatient-Centered Outcomes Research Institute; East Carolina University; Whatley...CompletedPain | Chronic Pain | Chronic Pain Syndrome | Widespread Chronic Pain | Chronic Pain Due to InjuryUnited States
-
University of UtahRecruitingChronic Pain | Chronic Pain Syndrome | Widespread Chronic PainUnited States
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Thoracotomy | Postoperative Pain, Acute | Postoperative Pain, ChronicTurkey
-
Evolve Restorative CenterFlowonix Medical; Celéri Health, Inc.; Advanced Infusion SolutionsCompletedPain, Chronic | Pain, Intractable | Chronic Nonmalignant PainUnited States
-
Assiut UniversityNot yet recruiting
-
Vastra Gotaland RegionActive, not recruitingPain, Chronic | Widespread Chronic PainSweden
-
Washington University School of MedicineCompletedHip Pain Chronic | Back Pain | Chronic Pain | Knee Pain ChronicUnited States
Clinical Trials on Tai Chi
-
Harvard University Faculty of MedicineBeth Israel Deaconess Medical Center; Brigham and Women's HospitalCompleted
-
Lidian ChenPeking University Third HospitalNot yet recruiting
-
Taipei Veterans General Hospital, TaiwanNational Science Council, TaiwanCompleted
-
University Hospital, Clermont-FerrandCompleted
-
Chang Gung Memorial HospitalCompleted
-
Texas Tech University Health Sciences CenterActive, not recruiting
-
Massachusetts General HospitalUnknown
-
Chen Li TienCompletedExercise TrainingTaiwan
-
Chengdu University of Traditional Chinese MedicineUnknown
-
Tufts Medical CenterNational Center for Complementary and Integrative Health (NCCIH)Completed