Back to resultsA Brain Imaging Study of Tai Chi on Fibromyalgia
Primary Purpose
Fibromyalgia
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tai chi
Sponsored by
About this trial
This is an interventional basic science trial for Fibromyalgia focused on measuring fMRI
Eligibility Criteria
Criteria for fibromyalgia patients.
Inclusion Criteria:
- Volunteers 18-50 years of age.
- Fibromyalgia for at least the past 3 months, as determined by the referring physician.
- At least a 10th grade English-reading level; English can be a second language provided that the patients feel they understand all the questions used in the assessment measures.
Exclusion Criteria:
- Specific causes of pain (e.g., cancer, fractures, spinal stenosis, infections)
- History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome.
- Presence of any contraindications to fMRI scanning. For example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy.
Criteria for healthy adults.
Inclusion Criteria:
- Volunteers 18-50 years of age.
- At least a 10th grade English-reading level; English can be a second language provided that the patients feel they understand all the questions used in the assessment measures.
Exclusion Criteria:
- Chronic and acute pain (ex. Fibromyalgia).
- History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome.
- Presence of any contraindications to fMRI scanning. For example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy.
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Role of Tai Chi in Fibromyalgia
Arm Description
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. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. For the remaining sessions, the subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm-up and self-massage and a review of Tai Chi principles; (2) Tai Chi movement; (3) breathing techniques; (4) relaxation. Each component of the program derives from classical Yang style Tai Chi 108 posture.30
Outcomes
Primary Outcome Measures
Arterial spin labeling (ASL) before and after Tai Chi intervention.
A method to assess cerebral blood flow change (at rest) through functional magnetic in resonance imaging in response to Tai Chi intervention.
Secondary Outcome Measures
Resting-state BOLD fMRI before and after Tai Chi intervention.
A method to measure spontaneous brain activity fluctuations through functional magnetic resonance imaging in response to Tai Chi intervention.
Full Information
NCT ID
NCT01857219
First Posted
December 6, 2012
Last Updated
February 24, 2020
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01857219
Brief Title
A Brain Imaging Study of Tai Chi on Fibromyalgia
Official Title
A Brain Imaging Study of Tai Chi on Fibromyalgia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
August 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To accomplish our Specific Aims, we propose to conduct a two-session fMRI experiment in up to 30 patients with fibromyalgia (FM) and up to 30 healthy controls. All subjects will be invited to complete the second, identical fMRI session about 3 months following completion of the first session. Fibromyalgia subjects will complete their scans before and after a 12-week Tai Chi intervention in collaboration with Tufts Medical Center.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
fMRI
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Role of Tai Chi in Fibromyalgia
Arm Type
Experimental
Arm Description
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.
In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. For the remaining sessions, the subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm-up and self-massage and a review of Tai Chi principles; (2) Tai Chi movement; (3) breathing techniques; (4) relaxation. Each component of the program derives from classical Yang style Tai Chi 108 posture.30
Intervention Type
Behavioral
Intervention Name(s)
Tai chi
Primary Outcome Measure Information:
Title
Arterial spin labeling (ASL) before and after Tai Chi intervention.
Description
A method to assess cerebral blood flow change (at rest) through functional magnetic in resonance imaging in response to Tai Chi intervention.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Resting-state BOLD fMRI before and after Tai Chi intervention.
Description
A method to measure spontaneous brain activity fluctuations through functional magnetic resonance imaging in response to Tai Chi intervention.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Criteria for fibromyalgia patients.
Inclusion Criteria:
Volunteers 18-50 years of age.
Fibromyalgia for at least the past 3 months, as determined by the referring physician.
At least a 10th grade English-reading level; English can be a second language provided that the patients feel they understand all the questions used in the assessment measures.
Exclusion Criteria:
Specific causes of pain (e.g., cancer, fractures, spinal stenosis, infections)
History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome.
Presence of any contraindications to fMRI scanning. For example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy.
Criteria for healthy adults.
Inclusion Criteria:
Volunteers 18-50 years of age.
At least a 10th grade English-reading level; English can be a second language provided that the patients feel they understand all the questions used in the assessment measures.
Exclusion Criteria:
Chronic and acute pain (ex. Fibromyalgia).
History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome.
Presence of any contraindications to fMRI scanning. For example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian Kong, MD, MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Brain Imaging Study of Tai Chi on Fibromyalgia
We'll reach out to this number within 24 hrs