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Sponsors and Collaborators: |
Department of Veterans Affairs University of California, San Diego |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00608530 |
This double blind, randomized, parallel groups, two arm, six month clinical trial. Patients will have chronic low back pain of non-neoplastic origin.
Patients will be randomized to one of two conditions, either Cognitive Behavioral Training or Rogerian psychotherapy; both conditions are home-based, telephone supported, with 10 hours of contact time delivered over 8 weeks.
Condition | Intervention | Phase |
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Pain Back Pain |
Behavioral: Cognitive behavioral therapy Behavioral: Rogerian psychotherapy |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Telehealth Outreach for Chronic Back Pain |
Estimated Enrollment: | 130 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
10 hours of Cognitive Behavioral Training delivered over 8 weeks by telephone and face-to-face contact
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Behavioral: Cognitive behavioral therapy
Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms
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2: Active Comparator
10 hours of Rogerian Psychotherapy delivered over 8 weeks by telephone and face-to-face contact
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Behavioral: Rogerian psychotherapy
Rogerian therapy encourages self-identification of goals and solutions using a supportive but not didactic approach
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Chronic low back pain (CLBP) is a major medical problem for the VA, affecting up to 15% of all veterans in primary care. Furthermore, prior surveys indicate CLBP is a leading cause of medical discharge of active duty personnel, and of medical disability costs. Given current demands on military personnel it is likely the burden of chronic pain will increase. The VHA has adopted the Agency for Health Care Policy and Research Guidelines for evaluation of back pain but these guidelines do not provide specifics for true rehabilitation. It is acknowledged that most back pain patients are not surgical candidates, that medications provide only limited analgesia, and that symptom control and improved function require a comprehensive approach addressing the cognitive, affective, and behavioral aspects of chronic pain. Fortunately, structured, specific interventions to both address the multidimensional nature of pain and operationalize treatment principles in primary care settings are available. These interventions, which reflect the VA emphasis on patient-centered care, can be effective in reducing disability and pain, but are a frequently overlooked component of effective care. One reason is that most clinics lack appropriately trained specialists. Moreover, even when specialists are available, the prevailing clinic-based service model is either too resource-intensive, or presents barriers to access. One approach to addressing some these barriers is the use of "telehealth" outreach. Studies in diverse medical disorders and some chronic pain syndromes suggest that care can be delivered efficiently and effectively with minimal therapist contact in home-based treatment models, using telephone consultation to replace clinic visits. These approaches are fully congruent with recent VHA telehealth initiatives to improve access and cost efficiency. We have extensive experience in VA Pain Clinic settings using a face-to-face, 8-week, 8-hours contact time CBSST program and have shown that it can be effective in reducing disability and pain, and improving mood in chronic back pain.
We propose a double blind, randomized assignment, two-arm, parallel groups, six month clinical trial. Patients with CLBP will be recruited from VA San Diego primary care clinics and the community. Subjects will receive either Cognitive-Behavioral Training (N = 65) or Rogerian Psychotherapy (N=65) in a home-based, telephone delivered format for a total of 10 hours of therapist contact time. Assessments will be conducted at baseline and at end of treatment, and at one, three and six months post-treatment. The primary data analytic strategy will be an intent-to-treat analysis (last observation carried forward) of all participants as randomized. The primary end point will be physical function (Roland & Morris Disability) at end of 8-week treatment; secondary end points will be pain intensity (Numeric Rating Scale) and mood (Beck Depression Inventory, Profile of Mood States).
Supplemental analyses will be conducted to test for durability of therapeutic effect at one, three, and six month post-treatment. Rigorously controlled clinical trials of the type we propose could contribute to more effective and more cost-efficient back pain treatment.
Key Words: Back Pain, Cognitive-Behavioral Treatment, Clinical Trial
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Judy Ortega, BA | (858) 642-3830 | judith.ortega@va.gov |
Contact: Shetal Patel, PhD | (858) 642-3830 | backpainresearch@vapop.ucsd.edu |
United States, California | |
VA San Diego Healthcare System, San Diego | Recruiting |
San Diego, California, United States, 92161 | |
Contact: Robert M Smith, MD BS 858-642-3657 robert.smith2@va.gov | |
Contact: Janet M Peyton, MA (858) 642-3657 janet.peyton@va.gov | |
Principal Investigator: Joseph H. Atkinson, MD |
Principal Investigator: | Joseph H. Atkinson, MD | VA San Diego Healthcare System, San Diego |
Responsible Party: | Department of Veterans Affairs ( Atkinson, Joseph - Principal Investigator ) |
Study ID Numbers: | B4767R |
Study First Received: | January 22, 2008 |
Last Updated: | April 22, 2009 |
ClinicalTrials.gov Identifier: | NCT00608530 History of Changes |
Health Authority: | United States: Federal Government |
pain chronic pain chronic back pain randomized clinical trial |
Signs and Symptoms Neurologic Manifestations Pain Back Pain |
Signs and Symptoms Nervous System Diseases Neurologic Manifestations Pain Back Pain |