Can Therapy Alter CNS Processing of Chronic Pain: A Longitudinal Study
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|ClinicalTrials.gov Identifier: NCT01794988|
Recruitment Status : Unknown
Verified February 2013 by Magdalena Naylor, MD, PhD, University of Vermont.
Recruitment status was: Recruiting
First Posted : February 20, 2013
Last Update Posted : February 20, 2013
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain||Behavioral: Group Cognitive Behavioral Therapy Behavioral: Pain Education Behavioral: Therapeutic Interactive Voice Response Behavioral: NO TIVR||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Can Therapy Alter CNS Processing of Chronic Pain: A Longitudinal Study|
|Study Start Date :||July 2010|
|Estimated Primary Completion Date :||June 2015|
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
- Pain [ Time Frame: Seven Months ]
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
|Contact: Marcia A. Davis, CAGSemail@example.com|
|Contact: Magdalena R. Naylor, MD, PhDfirstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator:||Magdalena Naylor, MD, PhD||Faculty, University of Vermont College of Medicine|