A Brain Imaging Study of Tai Chi on Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

A Brain Imaging Study of Tai Chi on Fibromyalgia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01857219
• Other study ID #: 2012P002574
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2013
• Est. completion date: August 2020

Study information

• Verified date: February 2020
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: August 2020
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Behavioral:
• Tai chi

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Charlestown	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks
Secondary	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.	12 weeks