Can Therapy Alter CNS Processing of Chronic Pain: A Longitudinal Study
Primary Purpose
Chronic Pain
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group Cognitive Behavioral Therapy
Pain Education
Therapeutic Interactive Voice Response
NO TIVR
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain focused on measuring Acute Pain, Low Back Pain, Back Pain, Functional Magnetic Resonance Imaging (fMRI), Cognitive Behavioral Therapy, Pain Education
Eligibility 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
Sites / Locations
- University of Vermont College of Medicine, MindBody Medicine ClinicRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Active Comparator
Arm Label
Group Cognitive Behavioral Therapy
Pain Education
Therapeutic Interactive Voice Response
No TIVR
Arm Description
Participants will undergo 11 weeks of group cognitive behavioral therapy (CBT) and a pre- and post-intervention MRI brain scan.
Participants will receive 11 weeks of pain education and a pre- and post-intervention MRI brain scan.
Four months of therapeutic interactive voice response (TIVR).
Control - no intervention
Outcomes
Primary Outcome Measures
Pain
Secondary Outcome Measures
Full Information
NCT ID
NCT01794988
First Posted
February 15, 2013
Last Updated
February 19, 2013
Sponsor
University of Vermont
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
1. Study Identification
Unique Protocol Identification Number
NCT01794988
Brief Title
Can Therapy Alter CNS Processing of Chronic Pain: A Longitudinal Study
Official Title
Can Therapy Alter CNS Processing of Chronic Pain: A Longitudinal Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2010 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Acute Pain, Low Back Pain, Back Pain, Functional Magnetic Resonance Imaging (fMRI), Cognitive Behavioral Therapy, Pain Education
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group Cognitive Behavioral Therapy
Arm Type
Experimental
Arm Description
Participants will undergo 11 weeks of group cognitive behavioral therapy (CBT) and a pre- and post-intervention MRI brain scan.
Arm Title
Pain Education
Arm Type
Active Comparator
Arm Description
Participants will receive 11 weeks of pain education and a pre- and post-intervention MRI brain scan.
Arm Title
Therapeutic Interactive Voice Response
Arm Type
Experimental
Arm Description
Four months of therapeutic interactive voice response (TIVR).
Arm Title
No TIVR
Arm Type
Active Comparator
Arm Description
Control - no intervention
Intervention Type
Behavioral
Intervention Name(s)
Group Cognitive Behavioral Therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Pain Education
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Therapeutic Interactive Voice Response
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
NO TIVR
Intervention Description
Control - no intervention
Primary Outcome Measure Information:
Title
Pain
Time Frame
Seven Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marcia A. Davis, CAGS
Phone
802-847-8241
Email
marcia.davis@vtmednet.org
First Name & Middle Initial & Last Name or Official Title & Degree
Magdalena R. Naylor, MD, PhD
Phone
802-847-4644
Email
magdalena.naylor@vtmednet.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magdalena Naylor, MD, PhD
Organizational Affiliation
Faculty, University of Vermont College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Vermont College of Medicine, MindBody Medicine Clinic
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcia A. Davis, CAGS
Phone
802-847-8241
Email
marcia.davis@vtmednet.org
12. IPD Sharing Statement
Links:
URL
http://www.uvm.edu/~mbmc/?Page=research/chronicPain.html&SM=researchSM.html
Description
MindBody Medicine Clinic Chronic Pain Research
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Can Therapy Alter CNS Processing of Chronic Pain: A Longitudinal Study
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