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Research Highlight

Treatments for Veterans with Chronic Low Back Pain: The CAMEO Trial

Musculoskeletal pain is common, accounting for two-thirds of all primary care visits for pain, and chronic low back pain (CLBP) is the most prevalent, disabling, and costly of all musculoskeletal pain conditions.¹ As highlighted in practice guidelines, many options are available to treat CLBP, yet management is difficult because of the lack of consensus to guide clinician decisions. Analgesics, or painkillers, remain the first line of treatment, but clinicians often do not use the entire array of analgesics that have been shown in clinical trials to be efficacious for CLBP.

Until recently, use of opioid analgesics has increased both outside and within VA for many pain conditions, including CLBP. While some pain experts viewed this trend as evidence of improved pain treatment, others have equated this practice to “flying blind,” given the paucity of trials evaluating the effectiveness and safety of opioids.² Many patients continue to experience severe, disabling pain despite opioid treatment; others report intolerable side effects from opioids. Primary care providers often struggle with opioid treatment decisions and worry about fostering prescription drug abuse, misuse, and opioid use disorder. These struggles have increased as the rate of prescription opioid overdose deaths in the United States has risen four-fold between 1999 and 2009, reflecting an epidemic of prescription opioid overdoses.³

For non-pharmacological treatments, the strongest trial evidence is for those that use cognitive or behavioral approaches. Despite this evidence, primary care settings have not routinely implemented non-pharmacological treatments for CLBP because of time constraints, lack of provider knowledge in non-pharmacological and self-management strategies, and limited availability of specialists to deliver non-pharmacological treatments. However, the integration of psychologists into VA primary care settings increases the feasibility of delivering non-pharmacological interventions. While multidisciplinary pain clinics produce the best outcomes using both pharmacological and nonpharmacological treatments, the availability of such clinics is limited. Even if more referral services were available, the enormous burden of CLBP among Veterans requires that most management still needs to occur in the primary care setting.

Given the heightened safety concerns surrounding analgesic use, especially opioids, and data revealing that analgesics provide clinically significant relief for only a minority of patients, research to compare pharmacological and nonpharmacological treatments to improve the management of CLBP is needed. To meet this need and address some barriers to effective pain management that can be practically applied in VA primary care settings, our research team designed the CAre Management for the Effective use of Opioids (CAMEO) Trial. CAMEO is an HSR&D-funded, two-armed randomized clinical trial to compare the effectiveness of pharmacological versus non-pharmacological approaches for primary care patients with CLBP. The pharmacological arm involves algorithm-based co-analgesic treatment coupled with guideline-concordant opioid management. Patients in the non-pharmacological arm (BEH) receive pain self-management and pain coping skills training. The primary study aim is to compare the interventions’ effects on pain intensity and function at 6 and 12 months.

The CAMEO interventions last for six months. This duration is predicated on the likelihood that prospective adjustment of medications will be required to optimize pharmacological treatment. In addition, pain self-management and coping skills will require time for the patient to learn, apply, and optimize non-pharmacological treatment for CLBP. The length of the follow up and schedule of outcome assessments are to detect three types of treatment effects: 1) “early” (3 months) intervention benefit; 2) immediate postintervention benefits at 6 months; and 3) sustained benefits at 9 and 12 months post-randomization.

Analgesics are the most common mode of treatment for chronic low back pain in primary care. However, monitoring of treatment response with appropriate adjustments and assessing adherence, side effects, and signs of misuse are often suboptimal in clinical practice. Many patients continue to have inadequate pain relief and poor functioning despite analgesics, including long-term opioids. Primary care providers (PCPs) need other treatment options if their patients’ CLBP does not respond to analgesics or if intolerable side effects emerge.

Effective pain management should encompass more than pharmacological management directed at pain scores; it should address a variety of contributing psychological, social, and behavioral factors. Nurse care managers or clinical psychologists, working in concert with PCPs, may be in an ideal position to identify these factors and deliver interventions that relieve Veterans’ pain. Nurse care management for optimized pharmacological management and psychologist-delivered optimized non-pharmacological treatment are central to CAMEO, and study findings will elucidate the comparative effectiveness of these two approaches.

References

1. Schappert S.M. “Ambulatory Care Visits to Physician Offices, Hospital Outpatient Departments, and Emergency Departments: United States, 1997,” Vital & Health Statistics 13 1999; 14:1-39.

2. Von Korff M. and Deyo R.A. “Potent Opioids for Chronic Musculoskeletal Pain: Flying Blind?" Pain 2004; 109:207-9.

3. Calcaterra S., Glanz J., and Binswanger I.A. “National Trends in Pharmaceutical Opioid Related Overdose Deaths Compared to other Substance Related Overdose Deaths: 1999-2009,” Drug Alcohol Dependence 2013; 131(3):263-70.