SMART Stepped Care Management for Low Back Pain in the Military Health System
This study will be a sequential, randomization trial where patients with chronic low back pain are initially randomized to receive one of two treatments (physical therapy OR Move 2 Health). This will be Phase I of the study intervention. Patients who do not respond to treatment after 6 weeks will undergo a subsequent sequential randomization. This will be Phase II of the study intervention. Patients in Phase II will be randomized to receive one of two treatments (addition of physical therapy or Move 2 Health, whichever one they did not receive OR the MORE Mindfulness intervention). Patients will be followed for one year after enrollment.
Julie M. Fritz, PT, PhD, FAPTA
Dan Rhon, PT, DPT, DSc, OCS, FAAOMPT
Impact and Contribution to PMC and Society
The Sequential Multiple Randomization Trial for Low Back Pain (SMART LBP Trial) will enable better integration of the biopsychosocial model and improve Stepped Care management with a pragmatic, randomized controlled trial targeting chronic low back pain at four large military installations in the United States.
University of Utah, Uniformed Services University of the Health Services (USUHS), Brooke Army Medical Center
Institute Providing Oversight: National Center for Complementary and Integrative Health (NCCIH)
Program Officer: Dave Clark, (NCCIH)
Project Scientist: Martha Matocha, National Institute of Nursing Research (NINR)
ClinicalTrials.gov Identifier: NCT04172038
Trial Status: Partial suspension due to COVID restriction
Chronic pain impacts civilian and military populations at epidemic levels that continue to grow at alarming rates. Chronic pain diagnoses have increased 3-fold among active duty personnel since 2007, with at least 40% of soldiers returning from deployment impacted. Improving pain management is a priority for the Military Health System (MHS). About 70% of active duty personnel with chronic pain have a secondary diagnosis of low back pain (LBP). Back pain is among the most common and costliest health conditions, is the leading cause of medical discharge across the military and a top reason for evacuation from deployment. High costs and adverse impact on readiness make LBP a particular concern for the MHS, and warrant a focus on this condition as a strategic priority to improve pain management in the MHS.
Concerns about pain management prompted chartering by the Army Surgeon General of the Army Pain Management Task Force (APMTF) which recommended pain should be managed by integrated teams employing a biopsychosocial model of care and incorporating the Veterans’ Health Administration Stepped Care Model of Pain Management. The VA Stepped Care Model emphasizes a continuum of evidence-based treatments beginning with less intensive options; proceeding to higher-intensity care for patients who do not respond. Various options exist at each step with little information on individualizing or sequencing treatments to optimize outcomes and manage costs.