SMART Stepped Care Management for Low Back Pain in the Military Health System
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Chronic Pain
- Low Back Pain
- Military Personnel
- Veterans
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Sequential AssignmentIntervention 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.Masking: Single (Outcomes Assessor)Masking Description: 8-week and 18-week follow-up assessments will be performed by a research assistant who will be blind to participants' treatment group assignment. Participants will be reminded by the research assistant not to discuss aspects of their treatment during assessments. If a research assistant becomes unblinded during the course of a participants study participation, he or she will not be allowed to conduct additional follow-up assessments. Instances of unblinding during an assessment will be recorded as an unexpected event.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
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 effect...
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.
Tracking Information
- NCT #
- NCT04172038
- Collaborators
- University of Utah
- National Center for Complementary and Integrative Health (NCCIH)
- Madigan Army Medical Center
- 59th Medical Wing
- Army Health Clinic Schofield Barracks
- Investigators
- Principal Investigator: Julie M Fritz, PhD University of Utah Principal Investigator: Daniel I Rhon, DSc Brooke Army Medical Center
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