NCT04172038

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 850 (actual)
• Sponsor: Brooke Army Medical Center · Federal
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Low Back Pain
• Chronic Pain
• Military Personnel
• Veterans

Interventions

Type	Name	Description
BEHAVIORAL	Physical Therapy	Physical therapy will be delivered using a guideline-concordant approach based off the Department of Defense -Veterans Affairs Low Back Pain Guidelines, focusing on risk-stratified care deliver (using the STarT Back tool as an adjunct).
BEHAVIORAL	Move 2 Health (M2H)	Participants will receive education for self-management (video and written materials) to introduce the key domains of holistic health in the Move to Health (M2H) model and their relationship to chronic LBP. Next, the participant will complete a Personal Health Inventory. The Inventory will be reviewed by the health coach and patient in order to identify specific domains for priority based on patient preference: 1. Sleep 2. Physical Activity 3. Nutrition 4. Intrinsic Well-Being (Personal Development, Spiritual Well-Being, Emotional Well-Being) 5. Extrinsic Well-Being (Family/Social Relationships, Surroundings) Care may range from guided self-management with the researcher to a specialist referral (e.g., sleep specialist, dietician, behavioral health provider, etc.).
BEHAVIORAL	MORE Mindfulness	Throughout the intervention, three core areas are emphasized. Activities include exercises and at-home work for participants to reinforce these core areas. 1. Mindfulness 2. Cognitive reappraisal 3. Savoring of positive experiences

Timeline

• Start date: 2019-12-09
• Primary completion: 2025-04-01
• Completion: 2025-07-01
• First posted: 2019-11-21
• Last updated: 2025-01-14

Locations

4 sites across 1 country: United States