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

July 14, 2023 updated by: Dan Rhon, Brooke Army Medical Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

850

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Hawaii
      • Schofield Barracks, Hawaii, United States, 96786
    • Texas
      • San Antonio, Texas, United States, 78219
        • Recruiting
        • Brooke Army Medical Center
        • Contact:
        • Principal Investigator:
          • Bryan Pickens, DSc
      • San Antonio, Texas, United States, 78236
        • Recruiting
        • Wilford Hall Ambulatory Surgical Center
        • Contact:
        • Principal Investigator:
          • Fern Daniels, DPT
    • Washington
      • Tacoma, Washington, United States, 98391
        • Recruiting
        • Madigan Army Medical Center
        • Contact:
        • Principal Investigator:
          • Brian Hatler, DPT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase I: Physical Therapy (PT)
Initial Randomization: The initial PT treatment session will occur within 7 days of enrollment in the study. Precise dosage (i.e, number of PT sessions) will be at the discretion of the physical therapist directing the participant's care, up to a maximum of 2-3 sessions per week over the 6-week Phase I treatment period.
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).
Other Names:
  • physiotherapy
Experimental: Phase I: Move to Health (M2H)
Initial Randomization: M2H is a key component of Army Medicine's "System for Health", along with the Performance Triad. It is a person-centered, holistic, and experience-centric approach to promoting healthy behaviors (nutrition, physical activity, sleep, instrinsic factors, extrinsic factors). Precise dosage (i.e, number of M2H sessions) will be at the discretion of the health coaches. Sessions may be delivered in-person or utilize technology including text messaging, telephone, e-mail, video chat, app-based self-management etc.
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.).
Experimental: Phase II: Combine PT & M2H
Sequential Randomization: Participants randomized to receive a combination of PT and M2H as a Phase II intervention will continue their Phase I treatment (either M2H or PT). The participant will begin the treatment component that was not part of their Phase I intervention.
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).
Other Names:
  • physiotherapy
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.).
Experimental: Phase II: MORE Mindfulness
Sequential Randomization: Participants randomized to receive mindfulness as a Phase II intervention will discontinue their Phase I treatment. The Mindfulness-Oriented Recovery Enhancement (MORE) treatment was designed specifically to address symptoms and underlying mechanisms of chronic pain in the military context and is led over 8 individual sessions.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PROMIS-Pain Interference Computer Adapted Test (PI-CAT)
Time Frame: 1 year
Computer-adapted assessment using a 44-item bank measuring the self-reported consequences of pain on relevant aspects of life including impact on social, emotional, cognitive, physical and recreational activities. All Patient-Reported Outcomes Measurement Information System (PROMIS®) scores are reported on a T-score metric with a score of 50 points aligning with the general population mean and a standard deviation of 10. Higher scores indicate greater pain interference.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PROMIS Physical Function Computer Adapted Test (PF-CAT)
Time Frame: 1 year
Computer-adapted assessment using a 121-item bank measuring current, self-reported capability related to physical activities. All PROMIS scores are reported on a T-score metric with a score of 50 points aligning with the general population mean and a standard deviation of 10. Higher scores indicate greater physical function.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brooke Army Medical Center

Collaborators

National Center for Complementary and Integrative Health (NCCIH)
59th Medical Wing
University of Utah
Madigan Army Medical Center
Tripler Army Medical Center

Investigators

  • Principal Investigator: Daniel I Rhon, DSc, Brooke Army Medical Center
  • Principal Investigator: Julie M Fritz, PhD, University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2019

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

November 18, 2019

First Submitted That Met QC Criteria

November 19, 2019

First Posted (Actual)

November 21, 2019

Study Record Updates

Last Update Posted (Actual)

July 18, 2023

Last Update Submitted That Met QC Criteria

July 14, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 908761
  • 4UH3AT009763-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

There are plans to share data within the NIH-DoD-VA Pain Management Collaboratory (PMC) for future initiatives related to the PMC

IPD Sharing Time Frame

Depends on the timeline established by the PMC

IPD Sharing Access Criteria

With reasonable request to the PI, and for any DHA-owned data, after following the established process by the Defense Health Agency to procure a Data Sharing Agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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