SMART Stepped Care Management for Low Back Pain in the Military Health System
Active, not recruitingNot applicableNCT04172038
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- SMART Stepped Care Management for Low Back Pain in the Military Health System
- Conditions
- Low Back Pain
- Chronic Pain
- Military Personnel
- Veterans
- Interventions
- Behavioral: Physical Therapy
- Behavioral: Move 2 Health (M2H)
- Behavioral: MORE Mindfulness
- 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
- Start date
- 2019-12-09
- Primary completion
- 2025-04
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 4
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Active duty military member (Army, Navy, Air Force, Marines) or member of Reserves or National Guard on active duty, a family member of active duty personnel, or Tricare beneficiary receiving care in a participating Military Treatment Facility. 2. Age 18 - 65 years at the time of enrollment. 3. Receiving Step 1 chronic LBP care based on VA Stepped Care Pain Management model defined as: a. Seen by a health care provider for chief complaint of LBP with or without symptoms into the buttocks or legs within past the 30 days. * Chief complaint of LBP which may be self-reported or identified by primary International Classification of Disease (ICD), 10th edition codes of LBP (M54.5, M54.9, S33.012), lumbar degenerative change (M51.36, M51.37, M48.06, M47.817), lumbar disc herniation/radiculitis (M54.16, M54.17, M51.26, M51.27, M54.3). 4. Meets NIH Task Force145 definition of chronic LBP based on two questions: How long has LBP has been an ongoing problem for you? and How often has LBP been an ongoing problem for you over the past 6 months? A response of greater than 3 months to question 1, and "at least half the days in the past 6 months" to question 2 is required to satisfy the NIH definition of chronic LBP. 5. Anticipates ability to attend treatment sessions over a 16 week period following enrollment with no planned absence of 2 weeks or more for training, vacation or any purpose. Exclusion Criteria: 1. Signs of serious or systemic pathology as a cause of LBP including spine fracture, neoplasm, inflammatory disease (e.g., ankylosing spondylitis), vertebral osteomyelitis, etc. 2. Knowingly pregnant 3. Has received interventions for LBP that involves providers other than primary care in the past 6 months. This includes physical therapy or behavioral pain management or counseling as well as specialist physician consultations, chiropractic, etc. 4. Has received any interventional pain procedures (e.g., spinal injections), inter-disciplinary pain management, integrated chronic pain and substance use treatment programs, etc. in the past 6 months 5. Has received any lumbar spine surgery in the past year. 6. Retiring from active duty within 12 months, pending a medical evaluation board, discharge from the military for medical reasons, or pending or undergoing any litigation for an injury. 7. At elevated acute risk for suicide (i.e., risk is below the level requiring either consultation or urgent action based on Veterans Affairs-Department of Defen…
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04172038