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Neuroimaging Effects of Cognitive Behavioral Therapy in Fibromyalgia

This study is currently recruiting participants.
Verified July 2016 by Robert Edwards, Brigham and Women's Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01345344
First Posted: May 2, 2011
Last Update Posted: July 19, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
Massachusetts General Hospital
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Robert Edwards, Brigham and Women's Hospital
  Purpose

This study design has two components: 1) a cross sectional assessment of brain connectivity and response to pain in healthy controls and demographically matched fibromyalgia patients, and 2) a longitudinal assessment of the same outcomes in fibromyalgia patients randomized to either CBT (Cognitive Behavioral Therapy) or a Disease Education condition.

The investigators will evaluate 90 fibromyalgia patients who will receive CBT treatment once a week for 8 weeks, for a total of 8 treatments. Baseline data from these patients will be compared to results from 30 pain-free controls and 60 education program controls.

Participants will undergo experimental pain assessments as well as brain neuroimaging.


Condition Intervention
Fibromyalgia Behavioral: Cognitive Behavioral Therapy Behavioral: Education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Official Title: Neuroimaging Effects of Cognitive Behavioral Therapy in Fibromyalgia

Resource links provided by NLM:


Further study details as provided by Robert Edwards, Brigham and Women's Hospital:

Primary Outcome Measures:
  • Clinical outcome: Brief Pain Inventory (BPI) [ Time Frame: 6 Months Post-treatment ]
  • Pain Neurocircuitry (MRI) [ Time Frame: Post-treatment (8 weeks) ]
    Bold responses will be assessed with fMRI (3T)


Secondary Outcome Measures:
  • Catastrophizing (PCS) [ Time Frame: 4 weeks ]
    Catatrophizing will be assessed with the Pain Catastrophizing Scale (PCS).Investigators hypothesize that early-treatment changes in catastrophizing will produce adaptive brain changes at post-treatment, and clinical improvement at 6 months.


Estimated Enrollment: 200
Study Start Date: May 2014
Estimated Study Completion Date: April 2019
Estimated Primary Completion Date: April 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive-Behavioral Therapy
Practicing certain strategies such as relaxation and changing negative thoughts about pain.
Behavioral: Cognitive Behavioral Therapy
Practicing certain strategies such as relaxation and changing negative thoughts about pain.
Active Comparator: Education
Giving information about pain and how to change perceptions of pain.
Behavioral: Education
Giving participants information about pain and how to change perceptions of pain.
No Intervention: Healthy Controls
No intervention

Detailed Description:
Investigators propose to use fMRI (functional Magnetic Resonance Imaging) to study CNS pain processing during the anticipation and experience of acute pain in individuals with FM and healthy controls. Investigators will recruit patients who are diagnosed with FM as well as healthy controls. After the baseline visit, FM participants will be randomly assigned into the CBT or control condition (Education). Overall, FM Participants will attend 8 treatment visits, and 6 assessment visits (two at baseline, one at mid-treatment, two at the end of treatment, and one at 6 months post-treatment). These assessment visits include a total of 3 fMRI sessions (at baseline, mid-treatment, and end of treatment). Healthy Controls will undergo the same baseline procedures as the FM subjects but will not attend any of the treatment or follow up assessment visits. Findings from this research will provide important information about catastrophizing's CNS (Central Nervous System) correlates.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for FM patients:

  1. aged 18-65
  2. female
  3. have a clinical diagnosis of fibromyalgia and meet the Wolfe et al 2011 research criteria for fibromyalgia
  4. on stable doses of medication prior to entering the study and agree not to change medications or dosages (or CAM treatments) during the trial
  5. right-handed
  6. baseline pain intensity of at least 4/10 on average and pain report for at least 50% of days
  7. able to provide written consent.

Exclusion Criteria for FM:

  1. comorbid acute pain condition
  2. comorbid chronic pain condition that is rated by the subject as more painful than fibromyalgia
  3. current use of opioid analgesics or stimulant medications or the fatigue associated with sleep apnea or shift work (e.g., modafinil)
  4. Routine or daily use of narcotics, marijuana or substances of abuse
  5. Certain condition that intervene with Quantitative Sensory Testing (QST) and/or fMRI procedures (e.g., Peripheral neuropathy, implanted ferrous metal, claustrophobia etc) or/and any impairment, activity or situation that could prevent satisfactory completion of the study protocol (e.g unreliable, or inconsistent pain scores).

Inclusion Criteria for Healthy Control Participants

  1. aged 18-65
  2. female
  3. right-handed
  4. able to provide written consent

Exclusion criteria for Healthy Control Participants:

  1. any acute or chronic pain condition (e.g., FM, arthritis)
  2. current use of opioid analgesics or stimulant medications or the fatigue associated with sleep apnea or shift work (e.g., modafinil)
  3. Routine or daily use of narcotics, marijuana or substances of abuse
  4. Certain condition that intervene with Quantitative Sensory Testing (QST) and fMRI procedures (e.g., Peripheral neuropathy, implanted ferrous metal, claustrophobia etc) or any impairment, activity or situation would prevent satisfactory completion of the study protocol (e.g unreliable, or inconsistent pain scores). This includes unreliable, or inconsistent pain scores as deemed by the principal investigator.
  Contacts and Locations
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): NCT01345344


Contacts
Contact: Olivia J Franceschelli, B.S. 617-732-9718 ext 29718 ofranceschelli@partners.org

Locations
United States, Massachusetts
Massaschusetts General Hospital Recruiting
Charlestown, Massachusetts, United States, 02129
Contact: Katerina Protsenko, BS BA       eprotsenko@mgh.harvard.edu   
Principal Investigator: Vitaly Napadow, PhD, Lic.Ac         
Brigham and Women's Hospital Recruiting
Chestnut Hill, Massachusetts, United States, 02467
Contact: Olivia Franceschelli    617-732-9014    ofranceschelli@partners.org   
Principal Investigator: Robert R Edwards, PhD         
Sponsors and Collaborators
Brigham and Women's Hospital
Massachusetts General Hospital
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
Principal Investigator: Robert R Edwards, PhD Brigham and Women's Hospital
  More Information

Responsible Party: Robert Edwards, Robert R. Edwards PhD, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01345344     History of Changes
Other Study ID Numbers: 2009p001021
R01AR064367 ( U.S. NIH Grant/Contract )
First Submitted: April 27, 2011
First Posted: May 2, 2011
Last Update Posted: July 19, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases