Clinical trial NCT04172038: SMART Stepped Care Management for Low Back Pain in the Military Health System
Official title: SMART Stepped Care Management for Low Back Pain in the Military Health System
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Low Back Pain
Chronic Pain
Military Personnel
Veterans
Keywords: stepped care
physical therapy
mindfulness
holistic health
military medicine
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
Collaborators: name: University of Utah
name: National Center for Complementary and Integrative Health (NCCIH)
name: Madigan Army Medical Center
name: 59th Medical Wing
name: Tripler Army Medical Center
First posted: 2019-11-21
Enrollment: 850
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Sequential Multiple Randomization Trial (SMART) comparing the effectiveness and cost-effectiveness of Stepped Care pain management options, examining sequencing, and heterogeneity of effects in pre-specified subgroups.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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 Defense Clinical Practice Guideline for Assessment and Management of Patients at Risk for Suicide)

Primary outcomes:
measure: PROMIS-Pain Interference Computer Adapted Test (PI-CAT)
timeFrame: 1 year
Secondary outcomes:
measure: PROMIS Physical Function Computer Adapted Test (PF-CAT)
timeFrame: 1 year
Other outcomes:
Locations:
city: Schofield Barracks
country: United States
facility: Desmond Doss Health Clinic
state: Hawaii
city: San Antonio
country: United States
facility: Brooke Army Medical Center
state: Texas
city: San Antonio
country: United States
facility: Wilford Hall Ambulatory Surgical Center
state: Texas
city: Tacoma
country: United States
facility: Madigan Army Medical Center
state: Washington
Study officials:
affiliation: University of Utah
name: Julie M Fritz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brooke Army Medical Center
name: Daniel I Rhon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Main CJ, George SZ. Psychologically informed practice for management of low back pain: future directions in practice and research. Phys Ther. 2011 May;91(5):820-4. doi: 10.2522/ptj.20110060. Epub 2011 Mar 30.
citation: Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol. 2010 Nov;63(11):1179-94. doi: 10.1016/j.jclinepi.2010.04.011. Epub 2010 Aug 4.
citation: Chou R, Huffman LH; American Pain Society; American College of Physicians. Nonpharmacologic therapies for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Ann Intern Med. 2007 Oct 2;147(7):492-504. doi: 10.7326/0003-4819-147-7-200710020-00007.
citation: Rhon DI, Fritz JM, Greenlee TA, Dry KE, Mayhew RJ, Laugesen MC, Dragusin E, Teyhen DS. Move to health-a holistic approach to the management of chronic low back pain: an intervention and implementation protocol developed for a pragmatic clinical trial. J Transl Med. 2021 Aug 18;19(1):357. doi: 10.1186/s12967-021-03013-y.