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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2013 by Magdalena Naylor, MD, PhD, University of Vermont.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01794988
First Posted: February 20, 2013
Last Update Posted: February 20, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Magdalena Naylor, MD, PhD, University of Vermont
  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 (Participant, 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 Magdalena Naylor, MD, PhD, University of Vermont:

Primary Outcome Measures:
  • Pain [ Time Frame: Seven Months ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
Principal Investigator: Magdalena Naylor, MD, PhD Faculty, University of Vermont College of Medicine
  More Information

Additional Information:
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: R01AR059674-03 ( U.S. NIH Grant/Contract )
First Submitted: February 15, 2013
First Posted: February 20, 2013
Last Update Posted: February 20, 2013
Last Verified: February 2013

Keywords provided by Magdalena Naylor, MD, PhD, 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