The Functional Neuroanatomy of Catastrophizing: an fMRI Study

This study has been completed.
Sponsor:
Collaborators:
Massachusetts General Hospital
Arthritis Foundation
Information provided by (Responsible Party):
Robert Edwards, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01345344
First received: April 27, 2011
Last updated: February 21, 2013
Last verified: February 2013
  Purpose

This is a brain imaging study of pain responses. The study includes 2-7 visits, lasting from 1-2 hours each. You may be eligible if you are over 18 years old, are either generally healthy or have fibromyalgia, do not have a serious heart condition or certain other medical conditions, are not taking certain types of medications, and are not pregnant.The research takes place at the Brigham & Women's Pain Management Center, 850 Boylston St, Chestnut Hill, and at the MGH Martinos Center for Biomedical Imaging. For further information, please contact the study coordinator Chrissie Cahalan at 617-732-9014 or by email at CCahalan1@partners.org.


Condition Intervention
Fibromyalgia
Behavioral: Cognitive Behavioral Therapy
Behavioral: Education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Official Title: The Functional Neuroanatomy of Catastrophizing: an fMRI Study

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Use fMRI to assess the impact of catastrophizing on central pain processing [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Catastrophizing is a critically-important variable in shaping pain experiences. However, as only a single functional neuroimaging study of catastrophizing has been published (Gracely et al., 2004), we know little about the CNS correlates of pain-related catastrophizing. We will use fMRI to study individuals with arthritis, divided into high- and low-catastrophizers, during the experience of acute thermal pain.


Enrollment: 70
Study Start Date: August 2010
Study Completion Date: December 2011
Primary Completion Date: November 2011 (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.
Placebo Comparator: Education
Giving information about pain and how to change perceptions of pain.
Behavioral: Education
Giving you information about pain and how to change perceptions of pain.

Detailed Description:

This research is being done to learn about brain activation during brief applications of painful stimuli using MRI, a technique for making images pictures of the brain. MRI uses magnetic fields and radio waves and is not harmful. This study uses a new investigational technique called functional MRI (fMRI) which is a very fast MRI technique that will allow the investigators to evaluate changes in how blood flows to parts of your brain during the experience of pain. Findings from this study will have implications for understanding individual differences in the experience of pain.

If you are over 18 and have Fibromyalgia or are generally healthy, you may be eligible. Other eligibility criteria include: no major circulation or heart problems, nerve damage, and no use of certain kinds of medications or other substances. This study involves a first visit to the Brigham & Women's Pain Management Center, and a second visit to the MRI facility at MGH.

The first visit will be a screening visit, lasting around 2 hours. The second visit will involve a session of fMRI assessment and will last around 2 hours. Both of these visits will involve 2 kinds of tests to measure your sensory responses to pressure. For all of these tests, you can stop at any time.

Depending on your responses to pain, you may be invited to participate in a follow-up treatment study. This involves 4 visits with Dr. Edwards, the clinical psychologist and principle investigator of this study, for therapy that addresses thoughts about pain or Fibromyalgia education. These sessions will be followed by another fMRI visit identical to visit 2. You do not have to participate in this study, and if you start the study you can leave at any time without affecting your future treatment or participation in research studies.

If you would like to learn more about the study, please contact the study coordinator Chrissie Cahalan (617-732-9014 or ccahalan1@partners.org).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18 or older
  • Meet ACR criteria for RA or FM or be free from chronic pain and rheumatic disease
  • Score on the Pain Catastrophizing Scale in either the top or bottom third of the normative distribution

Exclusion Criteria:

  • History of anxiety disorders or significant anxiety symptoms interfering with fMRI procedures (e.g., panic)
  • History of cardiac events
  • History of significant head injury
  • Peripheral neuropathy
  • Use of certain centrally-acting analgesic medications other than over-the-counter preparations (which will be withdrawn for 24 hours prior to testing) or use of recreational drugs
  • Implanted medical or metallic objects
  • Pregnancy
  • Cardiac or nervous system disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01345344

Locations
United States, Massachusetts
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, United States, 02467
Sponsors and Collaborators
Brigham and Women's Hospital
Massachusetts General Hospital
Arthritis Foundation
Investigators
Principal Investigator: Robert R Edwards, PhD Brigham and Women's Hospital
  More Information

No publications provided

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
Study First Received: April 27, 2011
Last Updated: February 21, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 19, 2014