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

Study acronym: SMART LBP
StatusActive, Not Recruiting
PhaseNot applicable
Started
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.

Record History

See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv11
  2. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Dec 2024 to Apr 2025
    • Study completion date: Sep 1, 2025 to Jul 2025
    • Site details revised at 4 of 4 sites
    v10
  3. Re-verified, no change to tracked fieldsv9
  4. Primary completion date: Dec 2023 to Dec 2024
    • Enrollment target: 1200 to 850
    • Study completion date: Dec 1, 2024 to Sep 1, 2025
    v8
  5. Primary completion date: Jan 2022 to Dec 2023
    • Study completion date: Jan 1, 2023 to Dec 1, 2024
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Study sites: 3 to 4
    • Collaborators revised (5)
    v6
  2. Collaborators: 2 to 5v5
  3. Re-verified, no change to tracked fieldsv4
  4. Study description expanded, about 6 words
    • Eligibility criteria expanded, about 3 words
    v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    • Study completion date: Jan 2023 to Jan 1, 2023
    • Start date changed from estimate of Nov 2019 to Dec 9, 2019
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
(from sponsor)		 Low Back Pain, Chronic Pain, Military Personnel, Veterans
Related terms Chronic Pain, Low Back Pain
Enrollment 850 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov