Can Therapy Alter CNS Processing of Chronic Pain: A Longitudinal Study
NCT ID: NCT01794988
Last Updated: 2013-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2010-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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Group Cognitive Behavioral Therapy
Participants will undergo 11 weeks of group cognitive behavioral therapy (CBT) and a pre- and post-intervention MRI brain scan.
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.
Pain Education
Participants will receive 11 weeks of pain education and a pre- and post-intervention MRI brain scan.
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.
Therapeutic Interactive Voice Response
Four months of therapeutic interactive voice response (TIVR).
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.
No TIVR
Control - no intervention
NO TIVR
Control - no intervention
Interventions
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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.
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.
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.
NO TIVR
Control - no intervention
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
75 Years
ALL
Yes
Sponsors
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National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
University of Vermont
OTHER
Responsible Party
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Magdalena Naylor, MD, PhD
Magdalena R. Naylor, MD, PhD
Principal Investigators
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Magdalena Naylor, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Faculty, University of Vermont College of Medicine
Locations
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University of Vermont College of Medicine, MindBody Medicine Clinic
Burlington, Vermont, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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MindBody Medicine Clinic Chronic Pain Research
Other Identifiers
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