(NCCIH-DOD UG3AT009763, PI; Fritz, Co-I: Garland, $6,438,846, 2017 – 2023).
Chronic pain is a ubiquitous problem and growing concern for the Military Health System (MHS). Low back pain (LBP) is the most common condition that leads to chronic pain. Numerous recommendations have been made to improve care for LBP and chronic pain in the MHS, including implementation of a Stepped Care approach. Stepped Care is a treatment process that begins with broadly accessible, less intesive interventions that can benefit many patients. Those who do not respond to initial treatments are stepped up to more intensive treatment.
While Stepped Care is advocated for pain management, and has been beneficial for improving care in other chronic conditions, many questions remain about which treatments to use within each Step, and the importance of sequences of care decisions. The SMART Stepped Care Management Project will support an innovative Sequential Multiple Randomization Trial specifically designed to address these key questions.
The project brings together a team of researchers and clinicians from the MHS and Department of Defense along with a strong research team at the University of Utah with expertise in the planning of multi-site clinical trials, managing and analyzing research data, and facilitating the dissemination of the results. After a Planning Phase to finalize procedures, the SMART trial will be conducted. Patients in the MHS with chronic LBP will be randomly assigned to either receive Physical Therapy or the holistic Move to Health intervention. After 6 weeks we will determine patients’ responsiveness to their first treatment Step. Non-responders will be re-randomized to receive either Mindfulness-Oriented Recovery Enhancement (MORE) or treatment from an Integrative Pain Medicine Center.
Specific Aims for the SMART trial are:
- Conduct a SMART trial comparing effectiveness and cost effectiveness of Step 1 and 2 treatments in a Stepped Care approach for patients with LBP in the MHS with patient-centered and healthcare cost outcomes. Sub-aims will compare main effects of Step 1 and 2 treatment options and the sequencing effects of different treatment combinations; and
- Examine SMART trial results in pre-specified sub-groups based on sex/gender, age, and pain-related co-morbidities (PTSD, sleep disturbance, post-concussive symptoms).