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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

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Behavioral: Tai chi Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Brain Imaging Study of Tai Chi on Fibromyalgia
Study Start Date : January 2013
Actual Primary Completion Date : November 2015
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

Behavioral: Tai chi



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01857219


Locations
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United States, Massachusetts
Massachusetts General Hospital
Charlestown, Massachusetts, United States, 02129
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Jian Kong, MD, MPH Massachusetts General Hospital
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Responsible Party: Jian Kong, Assistant Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01857219    
Other Study ID Numbers: 2012P002574
First Posted: May 20, 2013    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
Keywords provided by Jian Kong, Massachusetts General Hospital:
fMRI
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases