Clinical Trial

SMART Stepped Care Management for Low Back Pain in the Military Health System

Study acronym: SMART LBP
Active, Not Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated January 14, 2025 (before its estimated April 2025 completion). Its status may not reflect the trial's current state.
Summary
This study will be sequential, randomization trial where patients with chronic low back pain are initially randomized to receive 1 of 2 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 1 of 2 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 1 year after enrollment.
Protocol Amendment History 10 amendments
This ClinicalTrials.gov record has been amended 10 times since 2019-11-19; most recent amendment 2025-01-13.
Status change: Recruiting → Active, Not Recruiting 2024-07-30
Status change: Not Yet Recruiting → Recruiting 2019-12-11
Trial Details
NCT Number NCT04172038
Lead Sponsor Brooke Army Medical Center
Collaborators: University of Utah, National Center for Complementary and Integrative Health (NCCIH), Madigan Army Medical Center, 59th Medical Wing, Tripler Army Medical Center
Conditions Low Back Pain, Chronic Pain, Military Personnel, Veterans
Enrollment 850 participants
Start Date 2019-12-09
Primary Completion 2025-04 (estimated)
Study Completion 2025-07 (estimated)
Updated on ClinicalTrials.gov 2025-01-14