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

NCT00796536 | Completed Phase 1

• 1 other identifier: R21AR055716
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain

Keywords

Acute Pain; Low Back Pain; Back Pain; Functional Magnetic Resonance Imaging (fMRI); Cognitive Behavioral Therapy; Pain Education

Outcome Measures

Primary Outcomes (1)

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

  Measured before and after the 12-week intervention

Secondary Outcomes (1)

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

  Measured before and after the 12-week intervention

Study Arms (2)

1

EXPERIMENTAL

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

Behavioral: Group cognitive behavioral therapy

2

ACTIVE COMPARATOR

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

Behavioral: Pain education

Interventions

Group cognitive behavioral therapy BEHAVIORAL

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.

1

Pain education BEHAVIORAL

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.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vermont: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

MindBody Medicine Clinic

Burlington, Vermont, 05401, United States

Location

Related Links

• Click here for more information about this study

MeSH Terms

Conditions

Chronic Pain; Acute Pain; Low Back Pain; Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Magdalena R. Naylor, MD, PhD

  MindBody Medicine Clinic, Department of Psychiatry, University of Vermont

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Magdalena R. Naylor, MD, PhD

Study Record Dates

• First Submitted: November 21, 2008
• First Posted: November 24, 2008
• Study Start: June 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: July 1, 2011
• Last Updated: February 18, 2013

Record last verified: 2013-02

Locations

US (1)