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

  • STATUS
    Recruiting
  • End date
    Jan 1, 2023
  • participants needed
    1200
  • sponsor
    Brooke Army Medical Center
Updated on 11 December 2021
analgesia
back pain
low back pain
pain relieving
lumbar disc herniation

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.

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.

Details
Condition Post-Surgical Pain, Low Back Pain, Back Pain, chronic pains, Chronic Pain, Veteran, Pain (Pediatric), Military Personnel, Chronic Back Pain, Lower Back Pain, lumbago, Pain
Treatment Physical therapy, Move 2 Health (M2H), MORE Mindfulness
Clinical Study IdentifierNCT04172038
SponsorBrooke Army Medical Center
Last Modified on11 December 2021

Eligibility

Yes No Not Sure

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
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)
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
\. 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
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)
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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