Telehealth Outreach for Chronic Back Pain (TELE)
|Pain Back Pain||Behavioral: Cognitive behavioral therapy Behavioral: Rogerian psychotherapy||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Telehealth Outreach for Chronic Back Pain|
- Roland and Morris Disability Questionnaire [ Time Frame: Baseline, End of Treatment (8 weeks) ]The Roland and Morris is a 24-item self-report measure of interference of back pain on everyday function at the present time. Each item is qualified by the phrase "because of my back pain" (e.g., "Because of my back I walk more slowly than usual . . . ; Because of my back I lie down to rest more often"). Scoring the measure involves summing the number of items endorsed (from 0 to 24). Lower scores indicate less disability.
- Numeric Pain Rating Scale (Numerical Rating Scale, 0-10) [ Time Frame: Baseline, End of Treatment (8weeks) ]The Numeric Pain Rating Scale asks the patient to rate their current intensity of pain on a scale from "0" to "1 0" where "0" indicates "no pain" and "10" indicates the "worst imaginable pain."
- Percentage of Participants With at Least 25% Improvement on Global Impression of Change [ Time Frame: End of Treatment (8 weeks) ]Participant rating of overall improvement compared to baseline in terms of back pain impact on everyday function, self-categorized as "Improved," "No change," or "Worse." Participants rating themselves as "Improved" were asked to estimate percentage of improvement (i.e., 1 to 100%). Percentage of participants with at least 25% improvement were compared between treatment groups.
|Study Start Date:||March 2008|
|Study Completion Date:||July 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
Experimental: Cognitive Behavioral Therapy
10 hours of Cognitive Behavioral Training delivered over 8 weeks by telephone and face-to-face contact
Behavioral: Cognitive behavioral therapy
Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms
Active Comparator: Supportive Psychotherapy
10 hours of Rogerian Psychotherapy delivered over 8 weeks by telephone and face-to-face contact
Behavioral: Rogerian psychotherapy
Rogerian therapy encourages self-identification of goals and solutions using a supportive but not didactic approach
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 VA 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 VA telehealth initiatives to improve access and cost efficiency. In VA Pain Clinic settings our face-to-face, 8-week, 8-hours contact time Cogntive Behavioral Self-Managment Skills Training (CBSST) program appears to 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 CBSST (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 patient-reported clinical global impression of change. 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00608530
|United States, California|
|VA San Diego Healthcare System, San Diego|
|San Diego, California, United States, 92161|
|Principal Investigator:||Joseph H. Atkinson, MD||VA San Diego Healthcare System, San Diego|