Can Therapy Alter CNS Processing of Chronic Pain: A Longitudinal Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University of Vermont
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Magdalena Naylor, MD, PhD, University of Vermont
ClinicalTrials.gov Identifier:
NCT01794988
First received: February 15, 2013
Last updated: February 19, 2013
Last verified: February 2013
  Purpose

The purpose of this study is to investigate whether a psycho-therapeutic approach, group Cognitive Behavioral Therapy (CBT) plus a relapse prevention program, Therapeutic Interactive Voice Response (TIVR), modifies the dysfunctional sensory, emotional, and cognitive neural circuitry associated with chronic pain.


Condition Intervention
Chronic Pain
Behavioral: Group Cognitive Behavioral Therapy
Behavioral: Pain Education
Behavioral: Therapeutic Interactive Voice Response
Behavioral: NO TIVR

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Can Therapy Alter CNS Processing of Chronic Pain: A Longitudinal Study

Resource links provided by NLM:


Further study details as provided by University of Vermont:

Primary Outcome Measures:
  • Pain [ Time Frame: Seven Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: July 2010
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group Cognitive Behavioral Therapy
Participants will undergo 11 weeks of group cognitive behavioral therapy (CBT) and a pre- and post-intervention MRI brain scan.
Behavioral: Group Cognitive Behavioral Therapy
Each CBT session will last 90 minutes and will teach participants specific skills to better cope with chronic pain. These skills will include breathing exercises, distraction, and relaxation techniques.
Active Comparator: Pain Education
Participants will receive 11 weeks of pain education and a pre- and post-intervention MRI brain scan.
Behavioral: Pain Education
Subjects 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.
Experimental: Therapeutic Interactive Voice Response
Four months of therapeutic interactive voice response (TIVR).
Behavioral: Therapeutic Interactive Voice Response
Therapeutic Interactive Voice Response as a daily self monitoring and relapse prevention tool with didactic reviews and practices of recorded skills and monthly feedback based on daily calls.
Active Comparator: No TIVR
Control - no intervention
Behavioral: NO TIVR
Control - no intervention

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least 12 months of muscular-skeletal, non-neuropathic pain

Exclusion Criteria:

  • Malignancy causing or influencing chronic pain
  • Radiation or chemotherapy, or metastatic cancer of any type
  • Reflex Sympathetic Dystrophy (RSD) and/or neuropathic pain
  • Neurological disorders such as epilepsy or stroke, or other medical conditions
  • Psychiatric disorders
  • Opioid medication use for pain management
  • Past year history of illicit drug use that can result in altered cognition
  • Pregnancy
  • Exceeding weight limit of the MRI scanner
  • Incompatible implants due to MRI safety
  • Awaiting pain related surgical procedure
  • Involved in pain-related litigation
  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: NCT01794988

Contacts
Contact: Marcia A. Davis, CAGS 802-847-8241 marcia.davis@vtmednet.org
Contact: Magdalena R. Naylor, MD, PhD 802-847-4644 magdalena.naylor@vtmednet.org

Locations
United States, Vermont
University of Vermont College of Medicine, MindBody Medicine Clinic Recruiting
Burlington, Vermont, United States, 05401
Contact: Marcia A. Davis, CAGS    802-847-8241    marcia.davis@vtmednet.org   
Sponsors and Collaborators
University of Vermont
Investigators
Principal Investigator: Magdalena Naylor, MD, PhD Faculty, University of Vermont College of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Magdalena Naylor, MD, PhD, Magdalena R. Naylor, MD, PhD, University of Vermont
ClinicalTrials.gov Identifier: NCT01794988     History of Changes
Other Study ID Numbers: R01 AR059674-03, R01AR059674-03
Study First Received: February 15, 2013
Last Updated: February 19, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Vermont:
Acute Pain
Low Back Pain
Back Pain
Functional Magnetic Resonance Imaging (fMRI)
Cognitive Behavioral Therapy
Pain Education

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014