Brief Summary

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Official Title: "Telehealth Outreach for Chronic Back Pain"

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.

• Study Type: Interventional
• Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Study Primary Completion Date: July 2011

Detailed Clinical Trial Description

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

Interventions Used in this Clinical Trial

• Behavioral: Cognitive behavioral therapy
  • Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms
• Behavioral: Rogerian psychotherapy
  • Rogerian therapy encourages self-identification of goals and solutions using a supportive but not didactic approach

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • 10 hours of Cognitive Behavioral Training delivered over 8 weeks by telephone and face-to-face contact
• Active Comparator: 2
  • 10 hours of Rogerian Psychotherapy delivered over 8 weeks by telephone and face-to-face contact

Outcome Measures for this Clinical Trial

Primary Measures

• Roland and Morris Disability Questionnaire
  • Time Frame: End of treatment (8 weeks)
    Safety Issue?: No

Secondary Measures

• Numeric Pain Rating Scale (Numerical Rating Scale, 0-100)
  • Time Frame: End of treatment (8weeks)
    Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria

1. Ages 18-75 inclusive;

2. chronic musculoskeletal low back pain (pain "on a daily basis" for at least six months) as the primary pain problem;

3. not eligible for back surgery;

4. presently lives in the San Diego area and will do so six months after baseline examination;

5. English-speaking, literate, with stable residence and phone.

Exclusion Criteria

1. Major medical illness (e.g., insulin-dependent diabetes mellitus with neuropathy or "poor control", heart disease with New York Heart Association Functional Class III or IV, or chronic obstructive pulmonary disease requiring supplemental oxygen which might confound effects of pain on function);

2. candidate for spine surgery;

3. back pain associated with pregnancy, rheumatoid arthritis, neoplastic disease, osteomyelitis, or neural arch lesions, since their treatment and prognosis differs from the usual back pain population, or spinal stenosis, since increased physical activity would be contraindicated;

4. history of DSM-IV bipolar disorder, dementia, or schizophrenia;

5. current active DSM-IV diagnosed alcohol or non-prescribed substance dependence;

6. current active DSM-IV major depressive episode or post-traumatic stress disorder since specialty mental health care would be indicated;

7. non-opioid and opioid analgesics are permitted, except we will exclude patients on a hospital-initiated opioid treatment "contract," since at this medical center "contracting" identifies patients with history of opioid diversion, multiple VA and non-VA opioid prescribers, and repeated dose escalation in the absence of evidence of disease progression.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

• Lead Sponsor
  • Department of Veterans Affairs
• Collaborator
  • University of California, San Diego
• Provider of Information About this Clinical Study
  • Atkinson, Joseph - Principal Investigator, Department of Veterans Affairs
• Overall Official(s)
  • Joseph H. Atkinson, MD, Principal Investigator, VA San Diego Healthcare System, San Diego