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Using Functional MRI to Evaluate Cognitive Behavioral Therapy Treatment Response in Adults With Chronic Pain

Primary Purpose

Chronic Pain

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Group cognitive behavioral therapy
Pain education
Sponsored by
University of Vermont
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Acute Pain, Low Back Pain, Back Pain, Functional Magnetic Resonance Imaging (fMRI), Cognitive Behavioral Therapy, Pain Education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • At least 6 months of musculoskeletal non-neuropathic pain confined to lumbar or thoracic back
  • Meets study threshold for severity of typical pain of 4 or more on a 10-point scale adapted from the McGill Pain Questionnaire
  • Has ongoing standard pain management from a physician
  • Agrees to participate in this research study

Exclusion Criteria:

  • Malignancy
  • Reflex sympathetic dystrophy and/or naturopathic pain
  • Opioid medication use
  • Substance use disorder
  • Neurological disorder, such as epilepsy, stroke, or other medical condition that could confound or interfere with the current study
  • Major depression or/and dysthymia
  • Post traumatic stress disorder or panic disorder
  • Left-handedness
  • Pregnancy
  • History of illicit drug use (cocaine, cannabis, heroin) that can result in altered cognition
  • Exceeding the weight limit on the MRI scanner
  • Suffering from claustrophobia
  • Any of the following: cardiac pacemakers, auto defibrillators, neural stimulators, aneurysm clips, metallic prostheses, cochlear implants, any implanted devices (pumps, infusion devices, stents), permanent eye make-up, intrauterine devices, shrapnel injuries

Sites / Locations

  • MindBody Medicine Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Participants will undergo 12 weeks of group cognitive behavioral therapy (CBT) and a pre- and post-intervention MRI brain scan.

Participants will received 12 weeks of pain education and a pre- and post-intervention MRI brain scan.

Outcomes

Primary Outcome Measures

Thermal pain threshold, tolerance, perception of acute pain, ability to decrease pain, and brain reactivity

Secondary Outcome Measures

Acute pain perception and brain activation correlated with improvement in clinical outcomes

Full Information

First Posted
November 21, 2008
Last Updated
February 15, 2013
Sponsor
University of Vermont
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT00796536
Brief Title
Using Functional MRI to Evaluate Cognitive Behavioral Therapy Treatment Response in Adults With Chronic Pain
Official Title
Using fMRI to Evaluate CBT Treatment Response for Patients With Chronic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Chronic pain is a condition in which pain continues for 1 month or more beyond the usual recovery period for an injury or illness or persists for months or years due to a chronic condition. A commonly used type of psychotherapy called cognitive behavioral therapy (CBT) has been found to be effective in treating people with chronic pain. The purpose of this study is to determine whether and how CBT geared specifically for treating chronic pain can change the way the brain responds to painful emotional and physical stimuli.
Detailed Description
Many recent studies have suggested that there is an overlap between pain and emotion-related neurophysiological processes. Several modern pain theories also advocate that pain should be considered as a complex sensory and emotional experience, rather than as an isolated sensory event. In accordance with these theories, it is reasonable to expect that an intervention such as CBT, which teaches patients to understand and control both the emotional and sensory aspects of pain, could alter the brain's responses to both pain and emotionally provocative stimuli and, consequently, change the underlying neural circuitry. To date, there are no published studies that explore the neurobiological effects of psychotherapeutic approaches, such as CBT, on chronic pain. A previous pilot study showed that the exaggerated amygdala response to negative emotional stimuli in chronic pain patients was normalized after 12 weeks of group CBT, suggesting that CBT may affect at least the emotional component of the pain process. Using functional magnetic resonance imaging (fMRI), which creates a three-dimensional picture of the brain, this study will determine the following: (1) whether CBT treatment changes the function of brain neural circuitry in response to acute noxious physical stimuli and to fearful emotional stimuli; and (2) how altered activation in brain areas associated with the attentional, affective, and sensory aspects of chronic pain relate to measurable improvement in someone's clinical response to group CBT. Directly measuring the effects of CBT on brain function could ultimately improve clinical decision making and contribute to the development of individualized treatment for patients with chronic pain. Participants will be randomly assigned to receive 12 weeks of either CBT or pain education, which will act as an attention control condition. Each CBT session will last for 90 minutes and will teach participants specific skills to better cope with chronic pain. These skills will include breathing exercises, distraction, and relaxation techniques. Each weekly pain education session, also lasting 90 minutes, will be structured as a group discussion and led by a health care counselor. During the session, participants will receive information about the nature of chronic back pain, talk about treatment options, learn exercises and stretching techniques for maintaining strength and flexibility, and learn how to protect their backs. Every participant will undergo two fMRI examinations: one before treatment and one after treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Acute Pain, Low Back Pain, Back Pain, Functional Magnetic Resonance Imaging (fMRI), Cognitive Behavioral Therapy, Pain Education

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Participants will undergo 12 weeks of group cognitive behavioral therapy (CBT) and a pre- and post-intervention MRI brain scan.
Arm Title
2
Arm Type
Active Comparator
Arm Description
Participants will received 12 weeks of pain education and a pre- and post-intervention MRI brain scan.
Intervention Type
Behavioral
Intervention Name(s)
Group cognitive behavioral therapy
Intervention Description
Each CBT session will last for 90 minutes and will teach participants specific skills to better cope with chronic pain. These skills will include breathing exercises, distraction, and relaxation techniques.
Intervention Type
Behavioral
Intervention Name(s)
Pain education
Intervention Description
Patients will receive mailed educational materials to their homes on a weekly basis. Weekly materials will contain information about the nature of chronic back pain, treatment options, exercises and stretching techniques for maintaining strength and flexibility, and proper protection for a healthy back. Pain education is the standard of care for most outpatient clinics.
Primary Outcome Measure Information:
Title
Thermal pain threshold, tolerance, perception of acute pain, ability to decrease pain, and brain reactivity
Time Frame
Measured before and after the 12-week intervention
Secondary Outcome Measure Information:
Title
Acute pain perception and brain activation correlated with improvement in clinical outcomes
Time Frame
Measured before and after the 12-week intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 6 months of musculoskeletal non-neuropathic pain confined to lumbar or thoracic back Meets study threshold for severity of typical pain of 4 or more on a 10-point scale adapted from the McGill Pain Questionnaire Has ongoing standard pain management from a physician Agrees to participate in this research study Exclusion Criteria: Malignancy Reflex sympathetic dystrophy and/or naturopathic pain Opioid medication use Substance use disorder Neurological disorder, such as epilepsy, stroke, or other medical condition that could confound or interfere with the current study Major depression or/and dysthymia Post traumatic stress disorder or panic disorder Left-handedness Pregnancy History of illicit drug use (cocaine, cannabis, heroin) that can result in altered cognition Exceeding the weight limit on the MRI scanner Suffering from claustrophobia Any of the following: cardiac pacemakers, auto defibrillators, neural stimulators, aneurysm clips, metallic prostheses, cochlear implants, any implanted devices (pumps, infusion devices, stents), permanent eye make-up, intrauterine devices, shrapnel injuries
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magdalena R. Naylor, MD, PhD
Organizational Affiliation
MindBody Medicine Clinic, Department of Psychiatry, University of Vermont
Official's Role
Principal Investigator
Facility Information:
Facility Name
MindBody Medicine Clinic
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.med.uvm.edu/mbmc/TB3+CL+BL+3I.asp?SiteAreaID=585
Description
Click here for more information about this study

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Using Functional MRI to Evaluate Cognitive Behavioral Therapy Treatment Response in Adults With Chronic Pain

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