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

• Sponsor: University of Vermont (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01794988
• Collaborator: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (NIH)
• Enrollment: 120
• Location: 1
• Arms: 4

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Chronic Pain	Behavioral: Group Cognitive Behavioral Therapy; Behavioral: Pain Education; Behavioral: Therapeutic Interactive Voice Response; Behavioral: NO TIVR	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• 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
• Study Start Date: Jul 1, 2010
• Anticipated Primary Completion Date: Jun 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Pain [Seven Months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	University of Vermont College of Medicine, MindBody Medicine Clinic	Burlington	Vermont	United States	05401

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• MindBody Medicine Clinic Chronic Pain Research

Publications

None provided.

• Responsible Party: Magdalena Naylor, MD, PhD, Magdalena R. Naylor, MD, PhD, University of Vermont
• ClinicalTrials.gov Identifier: NCT01794988
• Other Study ID Numbers: R01AR059674-03; R01AR059674-03
• First Posted: Feb 20, 2013
• Last Update Posted: Feb 20, 2013
• Last Verified: Feb 1, 2013

• Keywords provided by Magdalena Naylor, MD, PhD, Magdalena R. 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

Study Results

No Results Posted as of Feb 20, 2013