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A Brain Imaging Study of Tai Chi on Fibromyalgia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01857219
Recruitment Status : Active, not recruiting
First Posted : May 20, 2013
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
Jian Kong, Massachusetts General Hospital

Tracking Information
First Submitted Date  ICMJE December 6, 2012
First Posted Date  ICMJE May 20, 2013
Last Update Posted Date February 25, 2020
Study Start Date  ICMJE January 2013
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 27, 2017)
Arterial spin labeling (ASL) before and after Tai Chi intervention. [ Time Frame: 12 weeks ]
A method to assess cerebral blood flow change (at rest) through functional magnetic in resonance imaging in response to Tai Chi intervention.
Original Primary Outcome Measures  ICMJE
 (submitted: May 15, 2013)
Arterial spin labeling (ASL) [ Time Frame: single day ]
A method to assess cerebral blood flow change (at rest) through functional magnetic resonance imaging.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 27, 2017)
Resting-state BOLD fMRI before and after Tai Chi intervention. [ Time Frame: 12 weeks ]
A method to measure spontaneous brain activity fluctuations through functional magnetic resonance imaging in response to Tai Chi intervention.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2013)
Resting-state BOLD fMRI [ Time Frame: single day ]
A method to measure spontaneous brain activity fluctuations through functional magnetic resonance imaging.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Brain Imaging Study of Tai Chi on Fibromyalgia
Official Title  ICMJE A Brain Imaging Study of Tai Chi on Fibromyalgia
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Fibromyalgia
Intervention  ICMJE Behavioral: Tai chi
Study Arms  ICMJE Experimental: Role of Tai Chi in Fibromyalgia

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: Behavioral: Tai chi
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: May 15, 2013)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2020
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01857219
Other Study ID Numbers  ICMJE 2012P002574
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jian Kong, Massachusetts General Hospital
Study Sponsor  ICMJE Massachusetts General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jian Kong, MD, MPH Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP