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

Last updated: January 13, 2025
Sponsor: Brooke Army Medical Center
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Chronic Pain

Pain

Treatment

MORE Mindfulness

Physical Therapy

Move 2 Health (M2H)

Clinical Study ID

NCT04172038
908761
4UH3AT009763-03
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Active duty military member (Army, Navy, Air Force, Marines) or member of Reservesor National Guard on active duty, a family member of active duty personnel, orTricare 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 modeldefined as: a. Seen by a health care provider for chief complaint of LBP with or withoutsymptoms into the buttocks or legs within past the 30 days.

  • Chief complaint of LBP which may be self-reported or identified by primaryInternational 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).
  1. 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 anongoing problem for you over the past 6 months? A response of greater than 3 monthsto question 1, and "at least half the days in the past 6 months" to question 2 isrequired to satisfy the NIH definition of chronic LBP.

  2. Anticipates ability to attend treatment sessions over a 16 week period followingenrollment with no planned absence of 2 weeks or more for training, vacation or anypurpose.

Exclusion

Exclusion Criteria:

  1. Signs of serious or systemic pathology as a cause of LBP including spine fracture,neoplasm, inflammatory disease (e.g., ankylosing spondylitis), vertebralosteomyelitis, etc.

  2. Knowingly pregnant

  3. Has received interventions for LBP that involves providers other than primary carein the past 6 months. This includes physical therapy or behavioral pain managementor 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 usetreatment 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 anylitigation for an injury.

  7. At elevated acute risk for suicide (i.e., risk is below the level requiring eitherconsultation or urgent action based on Veterans Affairs-Department of DefenseClinical Practice Guideline for Assessment and Management of Patients at Risk forSuicide)

Study Design

Total Participants: 850
Treatment Group(s): 3
Primary Treatment: MORE Mindfulness
Phase:
Study Start date:
December 09, 2019
Estimated Completion Date:
July 31, 2025

Study Description

Improving non-pharmacologic management of chronic pain is a priority for the Military Health System (MHS) within the Department of Defense (DoD) and the most common chronic pain condition in the MHS and civilian healthcare is low back pain (LBP). Key questions exist however about the relative effectiveness of various strategies at different Steps, how to sequence treatments and individualize care based on specific patient characteristics and the resource implications. This study will recruit active duty military members or members of Reserves or National Guard on active duty, family members of active duty personnel, or Tricare beneficiaries seeing a primary care provider for chronic LBP in an MHS facility, ages 18-65. All participants will first receive 6 weeks of Phase I care with either physical therapy (PT) or Move to Health (M2H) interventions. After Phase I the investigators will assess response to initial treatment strategy. Phase I responders will be receive up to 2 additional sessions of treatment to facilitate a transition to self-management. Phase I non-responders will be randomly assigned to a more intensive Phase II treatment of either mindfulness or a combined PT+M2H intervention for 8 weeks. Randomization at each phase will be stratified by site, gender, and active duty status (adding Phase I treatment assignment at Phase II). Follow-up assessments for all participants will occur at 18 weeks (conclusion of Phase II), 6 months and 12 months after enrollment. Outcomes include patient-reported measures and health care costs.

Connect with a study center

  • Desmond Doss Health Clinic

    Schofield Barracks, Hawaii 96786
    United States

    Site Not Available

  • Brooke Army Medical Center

    San Antonio, Texas 78219
    United States

    Site Not Available

  • Wilford Hall Ambulatory Surgical Center

    San Antonio, Texas 78236
    United States

    Site Not Available

  • Madigan Army Medical Center

    Tacoma, Washington 98391
    United States

    Site Not Available

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