The purpose of the proposed clinical trial is to improve the care of older Veterans (age 65+) with chronic low back pain (CLBP, i.e., low back pain for at least 6 months on at least half the days). Current CLBP care is limited by being either overly spine-focused or generically prescribed. Spine-focused care often targets degenerative disease of the lumbar spine (e.g., degenerative disc/facet disease, disc bulge) that is nearly ubiquitous in older adults, even those who are pain-free. Generic CLBP care typically consists of physical therapy and oral analgesics, and many analgesics have potentially serious side effects in older adults such as gastrointestinal bleeding and hip fracture. Both spine-focused care and generic care often result in suboptimal improvement in pain and function. Through prior VA funding, we have laid the essential foundation for a patient-centered approach to care for older Veterans with CLBP, Aging Back Clinics (ABCs), in which the spine is a source of vulnerability but not the sole treatment target. ABCs approach CLBP as a geriatric syndrome, that is, a final common pathway for the expression of multiple contributors, not a disease of the spine. In our prior work we have: 1) Collaborated with 42 pain experts and primary care providers using a modified Delphi approach to develop 12 evidence-based, older adult-tailored evaluation and treatment algorithms for important conditions that contribute to pain and disability in older adults with CLBP, i.e., hip osteoarthritis, fibromyalgia, maladaptive coping, leg length discrepancy, anxiety, depression, myofascial pain, insomnia, sacroiliac joint syndrome, lateral hip/thigh pain (e.g., greater trochanteric pain syndrome), lumbar spinal stenosis, dementia. 2) Established the commonplace nature of these contributors in older Veterans. 3) Verified the feasibility and acceptability of ABC care to VA providers and Veterans. 4) Used iterative usability testing to develop an interactive tool, Take Back Your Back, that efficiently screens for non-musculoskeletal conditions (i.e., maladaptive coping, depression, anxiety, insomnia, fibromyalgia), and educates patients about realistic treatment expectations and CLBP as a biopsychosocial syndrome rather than a disease of the spine. The proposed randomized controlled clinical trial is designed to test the efficacy of ABCs as compared with Usual Care. Three hundred thirty Veterans age 65-89 (110 from each of 3 sites ? VA Pittsburgh Healthcare System, Dallas VA, Hunter Holmes McGuire [Richmond] VA) with CLBP and no red flags indicative of serious underlying illness will be randomized to ABCs or UC for 3 months and followed for 12 months after randomization. The ABCs will be virtual clinics staffed by consultants (e.g., geriatrics, pain medicine, rheumatology) trained in working with our algorithms who will refer patients to other providers (e.g., physical therapy, Behavioral Health, chiropractic) as needed. Usual care will not be constrained. Baseline measures will be assessed on site and include: the Minimal Data Set recommended by the NIH Task Force on research standards for CLBP; Oswestry Disability Index (ODI; main outcome); cognitive function (QMCI); PROMIS-29 that includes pain severity, pain-related activity interference, physical function, sleep disturbance, depressive symptoms, leg symptoms; quality of life with the PROMIS-Global Health (GH) scale, concerns about opioids with the Prescribed Opioids Difficulties Scale, gait speed, balance confidence with the Falls Efficacy Scale- International short form; and healthcare utilization over the prior month ? e.g., pain medications, emergency room visits, hospitalizations. Three, 6-, 9-, and 12-months outcomes (ODI, PROMIS 29 and GH, balance confidence, healthcare utilization) will be assessed over the telephone by staff masked to group assignment. We hypothesize that Veterans randomized to ABC care will experience significantly greater improvement in pain-related disability (ODI) than those in UC. The proposed clinical trial has the potential not only to improve pain-related disability, but also to reduce morbidity, increase quality of life and limit healthcare utilization.
Chronic low back pain (CLBP) is one of the most personally and fiscally costly conditions in the VA. In addition to pain and disability, older Veterans (i.e., those age 65 and older) are vulnerable to serious side effects from exposure to invasive procedures and toxic medications. Often patients with CLBP do not experience relief from the many treatments they receive when these treatments are spine-centered rather than patient-centered. There are many conditions outside of the spine that can cause CLBP and disability such as hip arthritis, fibromyalgia, and depression, but healthcare providers often do not recognize and treat these conditions as part of treating CLBP. We have developed protocols tailored to the needs of older adults for treating important CLBP and disability-causing conditions. The purpose of the proposed clinical trial is to compare the efficacy of Aging Backs Clinics that treat older Veterans with CLBP using these protocols as compared with usual care. The potential for improving outcomes for patients and saving precious healthcare resources is substantial.
