SMART Stepped Care Management for Low Back Pain in the Military Health System (NCT04172038) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
SMART Stepped Care Management for Low Back Pain in the Military Health System
United States850 participantsStarted 2019-12-09
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Age 18 - 65 years at the time of enrollment.
✓. Receiving Step 1 chronic LBP care based on VA Stepped Care Pain Management model defined as:
✓. Meets NIH Task Force145 definition of chronic LBP based on two questions:
✓. 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
✕. Signs of serious or systemic pathology as a cause of LBP including spine fracture, neoplasm, inflammatory disease (e.g., ankylosing spondylitis), vertebral osteomyelitis, etc.
✕. Knowingly pregnant
✕. 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.
What they're measuring
1
PROMIS-Pain Interference Computer Adapted Test (PI-CAT)
✕. 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
✕. Has received any lumbar spine surgery in the past year.
✕. 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.
✕. 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 Defense Clinical Practice Guideline for Assessment and Management of Patients at Risk for Suicide)