A Brain Imaging Study of Tai Chi on Fibromyalgia

NCT ID: NCT01857219

Last Updated: 2020-02-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2020-08-31

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.

Conditions

Fibromyalgia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Tai chi

Intervention Type: BEHAVIORAL

Interventions

Tai chi

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• 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

• 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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jian Kong

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jian Kong, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Charlestown, Massachusetts, United States

Countries

United States

Other Identifiers

2012P002574

Identifier Type: -

Identifier Source: org_study_id