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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

April 27, 2011
February 21, 2013
August 2010
November 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01345344 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Not Provided
 
The Functional Neuroanatomy of Catastrophizing: an fMRI Study
The Functional Neuroanatomy of Catastrophizing: an fMRI Study

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.

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).

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Fibromyalgia
  • Behavioral: Cognitive Behavioral Therapy
    Practicing certain strategies such as relaxation and changing negative thoughts about pain.
  • Behavioral: Education
    Giving you information about pain and how to change perceptions of pain.
  • Experimental: Cognitive-Behavioral Therapy
    Practicing certain strategies such as relaxation and changing negative thoughts about pain.
    Intervention: Behavioral: Cognitive Behavioral Therapy
  • Placebo Comparator: Education
    Giving information about pain and how to change perceptions of pain.
    Intervention: Behavioral: Education
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
December 2011
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01345344
2009p001021
No
Robert Edwards, Brigham and Women's Hospital
Brigham and Women's Hospital
  • Massachusetts General Hospital
  • Arthritis Foundation
Principal Investigator: Robert R Edwards, PhD Brigham and Women's Hospital
Brigham and Women's Hospital
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP