Chronic Pain
Conditions
Keywords
Acute Pain, Low Back Pain, Back Pain, Functional Magnetic Resonance Imaging (fMRI), Cognitive Behavioral Therapy, Pain Education
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.
Interventions
BEHAVIORALGroup 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.
BEHAVIORALPain 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.
BEHAVIORALTherapeutic 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.
BEHAVIORALNO TIVR
Control - no intervention
Sponsors
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
University of Vermont
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain | Seven Months |
Countries
United States
Contacts
Primary ContactMarcia A. Davis, CAGS
Backup ContactMagdalena R. Naylor, MD, PhD
Outcome results
None listed