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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Pain

Intervention / Treatment
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* Behavioral: Group Cognitive Behavioral Therapy
* Behavioral: Pain Education
* Behavioral: Therapeutic Interactive Voice Response
* Behavioral: NO TIVR


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Cognitive Behavioral Therapy<br>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<br>* 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.<br>|
| Active Comparator: Pain Education<br>Participants will receive 11 weeks of pain education and a pre- and post-intervention MRI brain scan. | Behavioral: Pain Education<br>* 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.<br>|
| Experimental: Therapeutic Interactive Voice Response<br>Four months of therapeutic interactive voice response (TIVR). | Behavioral: Therapeutic Interactive Voice Response<br>* 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.<br>|
| Active Comparator: No TIVR<br>Control - no intervention | Behavioral: NO TIVR<br>* Control - no intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain |  | Seven Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Pain, Low Back Pain, Back Pain, Functional Magnetic Resonance Imaging (fMRI), Cognitive Behavioral Therapy, Pain Education