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NCT01794988 Clinical Trial

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

Chronic Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01794988
Other study ID # R01AR059674-03
Secondary ID R01AR059674-03
Status Recruiting
Phase N/A
First received February 15, 2013
Last updated February 19, 2013
Start date July 2010

Study information
Verified date February 2013
Source University of Vermont
Contact Marcia A. Davis, CAGS
Phone 802-847-8241
Email marcia.davis@vtmednet.org
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date
Est. primary completion date June 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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.
• 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

Locations
Country Name City State
United States University of Vermont College of Medicine, MindBody Medicine Clinic Burlington Vermont

Sponsors (2)
Lead Sponsor Collaborator
University of Vermont National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain Seven Months No
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