• Roland and Morris Disability Questionnaire [ Time Frame: End of treatment (8 weeks) ] [ Designated as safety issue: No ]
  

• Numeric Pain Rating Scale (Numerical Rating Scale, 0-100) [ Time Frame: End of treatment (8weeks) ] [ Designated as safety issue: No ]
  

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. Generally conceptualized as Cognitive-Behavioral Self-management Skills Training (CBSST), 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 that CBSST is not widely available 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 CBSST can be delivered efficiently and effectively with minimal therapist contact in home-based care 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. Working with our consultant, a nationally recognized expert in home-based/telephone-assisted manualized interventions for chronic pain, we propose to adapt this program for home-based use and test its efficacy 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. Subjects will receive either Cognitive-Behavioral Self-management Skills Training, the home-based, telephone supported, minimal therapist contact intervention (N=65) delivered in over 8 weeks (total contact time = 8 hours), or a Supportive Care Control (N=65) condition matched for 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

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. will be in the San Diego area for at least 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.