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Tai Chi Intervention and Brain Imaging Study Among Fibromyalgia Patients and Healthy Controls (fMRI/FMEX)

Primary Purpose

Fibromyalgia, Chronic Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Tai Chi

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Tai Chi, fMRI

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Age 21 years or older.
Fulfills the American College of Rheumatology (ACR) 1990 classification criteria for FM: (1) a history of widespread musculoskeletal pain on the right and left sides of the body as well as above and below the waist for a minimum duration of 3 months, and (2) pain in 11 or more of 18 specific tender points with moderate or greater tenderness reported upon digital palpation.22
Fulfills the ACR 2010 diagnostic criteria for FM: (WPI ≥7 AND SS ≥5) OR (WPI 3-6 AND SS ≥9) and does not have a disorder that would otherwise explain the pain23
Willing to complete a 12-week, twice-a-week Tai Chi exercise program.
Willing to abstain from Aerobic Exercise or other new formalized exercise programs until completion of the study.
Willing to undergo MRI at baseline and follow-up.

Exclusion Criteria:

Prior experience with Tai Chi or other similar types of Complementary and Alternative Medicine in the past 1 year such as Qi gong and yoga since these share some of the principles of Tai Chi.
Dementia, neurological disease, cancer, cardiovascular disease, pulmonary disease, metabolic disease, renal disease, liver disease, or other serious medical conditions limiting ability to participate in the Tai Chi programs, as determined by the study physicians.
Any other diagnosed medical condition known to contribute to FM symptomatology, such as thyroid disease, inflammatory arthritis, systemic lupus erythematosis, rheumatoid arthritis, myositis, vasculitis or Sjogren's syndrome.
Inability to pass the Physical Activity Readiness Questionnaire (PAR-Q)
Inability to pass the Mini-Mental Status examination (with a score below 24)24 Enrollment in any other clinical trial within the last 30 days
Plan to permanently relocate from the region during the trial period
Presence of any contraindications to fMRI scanning. Including but not limited to: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy, weight >300 lbs
Non-English Speaking.

Sites / Locations

Tufts Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Tai Chi

Healthy Control

Arm Description

Participants who practice Tai Chi 2X/week for 12-weeks

24 healthy controls

Outcomes

Primary Outcome Measures

Brain Resting State Functional Connectivity as measured by fMRI

rostral anterior cingulate cortex (rACC), a key region in descending pain modulatory system (DPMS)

Secondary Outcome Measures

Cortical Thickness as measured by fMRI

Fibromyalgia Symptom Severity as measured by FIQR Questionnaire

FIQR

Widespread Pain Index as measured by Clinical Diagnostic Criteria for Fibromyalgia Questionnaire

Clinical Diagnostic Criteria for Fibromyalgia

Depression as measured by BECK-II Questionnaire

BECK-II

Stress/Anxiety as measured by Hospital Anxiety and Depression Scale

Hospital Anxiety and Depression Scale

Sleep Quality as measured by PSQI Questionnaire

PSQI

Quality of Life as measured by visual analog scale and SF-36 Questionnaire

VAS, SF-36

Mindfulness as measured by Five Facet Mindfulness Questionnaire

FFMQ

Self-Efficacy as by Chronic Pain and Self Efficacy Questionnaire

Chronic Pain Self Efficacy

Quantitative Sensory Testing as measured by an Algometer

Pain threshold

Full Information

NCT ID

NCT02407665

First Posted

March 18, 2015

Last Updated

February 9, 2016

Sponsor

Tufts Medical Center

Collaborators

Massachusetts General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02407665

Brief Title

Tai Chi Intervention and Brain Imaging Study Among Fibromyalgia Patients and Healthy Controls

Acronym

fMRI/FMEX

Official Title

A Pilot fMRI Study of Fibromyalgia: Tai Chi Intervention

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Completed

Study Start Date

March 2015 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tufts Medical Center

Collaborators

Massachusetts General Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This exploratory study proposal is the first pilot brain imaging study to determine if Tai Chi can modulate brain resting state functional connectivity (rsFC) and brain morphometry among fibromyalgia (FM) patients and healthy controls.

Detailed Description

Twenty-four FM patients and 24 age matched healthy control will be recruited. All FM patients will undergo Tai Chi intervention twice weekly for 12 weeks of practice. fMRI resting state and brain structure data will be collected before and after treatment. For the healthy control group, the fMRI and structure data will only be collected once, contemporaneous with the 12 week scan for the fibromyalgia patients. The primary outcome will be rsFC of rostral anterior cingulate cortex (rACC), a key region in descending pain modulatory system (DPMS). The secondary outcome include change of the cortical thickness changes, fibromyalgia symptom severity, widespread pain index, depression, stress/anxiety, sleep quality, and quality of life. Covariates include age, gender, body mass index, disease duration, depression, and comorbidities. Clinical outcome measurements will be collected at baseline and after 12 weeks of intervention for the fibromyalgia cohort and at a single visit for the healthy controls. The Tai Chi classes will be taught at Tufts Medical Center and the fMRI scans will be performed at Massachusetts General Hospital Martinos Center. The project will advance science in the field of mind-body medicine for chronic pain management, both mechanistically and clinically.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fibromyalgia, Chronic Pain

Keywords

Tai Chi, fMRI

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

55 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tai Chi

Arm Type

Experimental

Arm Description

Participants who practice Tai Chi 2X/week for 12-weeks

Arm Title

Healthy Control

Arm Type

No Intervention

Arm Description

24 healthy controls

Intervention Type

Behavioral

Intervention Name(s)

Tai Chi

Intervention 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

Primary Outcome Measure Information:

Title

Brain Resting State Functional Connectivity as measured by fMRI

Description

rostral anterior cingulate cortex (rACC), a key region in descending pain modulatory system (DPMS)

Time Frame

Modulation of impaired rsFC and brain structure at 12 weeks

Secondary Outcome Measure Information:

Title

Cortical Thickness as measured by fMRI

Time Frame

Baseline and 12-week

Title

Fibromyalgia Symptom Severity as measured by FIQR Questionnaire

Description

FIQR

Time Frame

Baseline, weekly, and 12-week

Title

Widespread Pain Index as measured by Clinical Diagnostic Criteria for Fibromyalgia Questionnaire

Description

Clinical Diagnostic Criteria for Fibromyalgia

Time Frame

Baseline and 12-week

Title

Depression as measured by BECK-II Questionnaire

Description

BECK-II

Time Frame

Baseline and 12-week

Title

Stress/Anxiety as measured by Hospital Anxiety and Depression Scale

Description

Hospital Anxiety and Depression Scale

Time Frame

Baseline and 12-week

Title

Sleep Quality as measured by PSQI Questionnaire

Description

PSQI

Time Frame

baseline and 12-week

Title

Quality of Life as measured by visual analog scale and SF-36 Questionnaire

Description

VAS, SF-36

Time Frame

baseline and 12-week

Title

Mindfulness as measured by Five Facet Mindfulness Questionnaire

Description

FFMQ

Time Frame

baseline and 12-week

Title

Self-Efficacy as by Chronic Pain and Self Efficacy Questionnaire

Description

Chronic Pain Self Efficacy

Time Frame

baseline and 12-week

Title

Quantitative Sensory Testing as measured by an Algometer

Description

Pain threshold

Time Frame

baseline and 12-week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 21 years or older. Fulfills the American College of Rheumatology (ACR) 1990 classification criteria for FM: (1) a history of widespread musculoskeletal pain on the right and left sides of the body as well as above and below the waist for a minimum duration of 3 months, and (2) pain in 11 or more of 18 specific tender points with moderate or greater tenderness reported upon digital palpation.22 Fulfills the ACR 2010 diagnostic criteria for FM: (WPI ≥7 AND SS ≥5) OR (WPI 3-6 AND SS ≥9) and does not have a disorder that would otherwise explain the pain23 Willing to complete a 12-week, twice-a-week Tai Chi exercise program. Willing to abstain from Aerobic Exercise or other new formalized exercise programs until completion of the study. Willing to undergo MRI at baseline and follow-up. Exclusion Criteria: Prior experience with Tai Chi or other similar types of Complementary and Alternative Medicine in the past 1 year such as Qi gong and yoga since these share some of the principles of Tai Chi. Dementia, neurological disease, cancer, cardiovascular disease, pulmonary disease, metabolic disease, renal disease, liver disease, or other serious medical conditions limiting ability to participate in the Tai Chi programs, as determined by the study physicians. Any other diagnosed medical condition known to contribute to FM symptomatology, such as thyroid disease, inflammatory arthritis, systemic lupus erythematosis, rheumatoid arthritis, myositis, vasculitis or Sjogren's syndrome. Inability to pass the Physical Activity Readiness Questionnaire (PAR-Q) Inability to pass the Mini-Mental Status examination (with a score below 24)24 Enrollment in any other clinical trial within the last 30 days Plan to permanently relocate from the region during the trial period Presence of any contraindications to fMRI scanning. Including but not limited to: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy, weight >300 lbs Non-English Speaking.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chenchen Wang, MD, MSc

Organizational Affiliation

Tufts University School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tufts Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

33472674

Citation

Kong J, Huang Y, Liu J, Yu S, Ming C, Chen H, Wilson G, Harvey WF, Li W, Wang C. Altered functional connectivity between hypothalamus and limbic system in fibromyalgia. Mol Brain. 2021 Jan 20;14(1):17. doi: 10.1186/s13041-020-00705-2.

Results Reference

derived

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Tai Chi Intervention and Brain Imaging Study Among Fibromyalgia Patients and Healthy Controls

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