FibromyalgiafMRI/FMEXNCT02407665
Tai Chi Intervention and Brain Imaging Study Among Fibromyalgia Patients and Healthy Controls
A study testing Tai Chi in people with Fibromyalgia and Chronic Pain, run by Tufts Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia, Chronic Pain
- What is being tested?
- Tai Chi
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot fMRI Study of Fibromyalgia: Tai Chi Intervention
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.
Read the 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.
- Conditions
- Fibromyalgia, Chronic Pain
- Being tested
- Tai Chi
- Keywords
- Tai Chi, fMRI
- Medical subject headings
- Fibromyalgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai ChiBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi | Experimental | Participants who practice Tai Chi 2X/week for 12-weeks Receives: Behavioral: Tai Chi |
| Healthy Control | No intervention | 24 healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain Resting State Functional Connectivity as measured by fMRI
rostral anterior cingulate cortex (rACC), a key region in descending pain modulatory system (DPMS)
Measured: Modulation of impaired rsFC and brain structure at 12 weeks
Secondary outcomes (10)
Cortical Thickness as measured by fMRI
Measured: Baseline and 12-week
Fibromyalgia Symptom Severity as measured by FIQR Questionnaire
FIQR
Measured: Baseline, weekly, and 12-week
Widespread Pain Index as measured by Clinical Diagnostic Criteria for Fibromyalgia Questionnaire
Clinical Diagnostic Criteria for Fibromyalgia
Measured: Baseline and 12-week
Depression as measured by BECK-II Questionnaire
BECK-II
Measured: Baseline and 12-week
Stress/Anxiety as measured by Hospital Anxiety and Depression Scale
Hospital Anxiety and Depression Scale
Measured: Baseline and 12-week
Sleep Quality as measured by PSQI Questionnaire
PSQI
Measured: baseline and 12-week
Quality of Life as measured by visual analog scale and SF-36 Questionnaire
VAS, SF-36
Measured: baseline and 12-week
Mindfulness as measured by Five Facet Mindfulness Questionnaire
FFMQ
Measured: baseline and 12-week
Self-Efficacy as by Chronic Pain and Self Efficacy Questionnaire
Chronic Pain Self Efficacy
Measured: baseline and 12-week
Quantitative Sensory Testing as measured by an Algometer
Pain threshold
Measured: baseline and 12-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Sponsor
- Investigators
- Chenchen Wang, MD, MSc, Principal investigator, Tufts University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02407665
- Sponsor's protocol ID
- 11552
- Acronym
- fMRI/FMEX
- Status last verified
- Feb 2016
- First submitted
- 18 Mar 2015
- Last updated
- 10 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 33472674
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot fMRI Study of Fibromyalgia: Tai Chi Intervention
- ClinicalTrials.gov ID
- NCT02407665
- Acronym / sponsor ID
- fMRI/FMEX / 11552
- Conditions
- Fibromyalgia, Chronic Pain
- Keywords
- Tai Chi, fMRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- Massachusetts General Hospital
- Study start
- Mar 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 3 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tai Chi | Experimental | Behavioral: Tai ChiParticipants who practice Tai Chi 2X/week for 12-weeks |
| Healthy Control | No intervention | –24 healthy controls |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tai ChiEach 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 | Behavioural | Tai Chi |
Primary outcome
Brain Resting State Functional Connectivity as measured by fMRI
Time frame: Modulation of impaired rsFC and brain structure at 12 weeks
rostral anterior cingulate cortex (rACC), a key region in descending pain modulatory system (DPMS)
10 secondary outcomes
Cortical Thickness as measured by fMRI
Time frame: Baseline and 12-week
Fibromyalgia Symptom Severity as measured by FIQR Questionnaire
Time frame: Baseline, weekly, and 12-week
Widespread Pain Index as measured by Clinical Diagnostic Criteria for Fibromyalgia Questionnaire
Time frame: Baseline and 12-week
Depression as measured by BECK-II Questionnaire
Time frame: Baseline and 12-week
Stress/Anxiety as measured by Hospital Anxiety and Depression Scale
Time frame: Baseline and 12-week
Sleep Quality as measured by PSQI Questionnaire
Time frame: baseline and 12-week
Quality of Life as measured by visual analog scale and SF-36 Questionnaire
Time frame: baseline and 12-week
Mindfulness as measured by Five Facet Mindfulness Questionnaire
Time frame: baseline and 12-week
Self-Efficacy as by Chronic Pain and Self Efficacy Questionnaire
Time frame: baseline and 12-week
Quantitative Sensory Testing as measured by an Algometer
Time frame: baseline and 12-week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2016.
- Derived from this study: PubMed 33472674Kong 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chenchen Wang, MD, MSc principal investigator
Tufts University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi in people with Fibromyalgia and Chronic Pain, run by Tufts Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain Resting State Functional Connectivity as measured by fMRI (time frame: Modulation of impaired rsFC and brain structure at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02407665, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2016.