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

NCT04172038 | Active Not Recruiting DMC

• 2 other identifiers: 9087614UH3AT009763-03
• Study Type: interventional
• Target: 850
• Locations: 1 country
• Sites: 4

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.

Conditions

Low Back Pain; Chronic Pain; Military Personnel; Veterans

Keywords

stepped care; physical therapy; mindfulness; holistic health; military medicine

Outcome Measures

Primary Outcomes (1)

• PROMIS-Pain Interference Computer Adapted Test (PI-CAT)

  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 Outcomes (1)

• PROMIS Physical Function Computer Adapted Test (PF-CAT)

  1 year

Study Arms (4)

Phase I: Physical Therapy (PT)

EXPERIMENTAL

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

Phase I: Move to Health (M2H)

EXPERIMENTAL

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)

Phase II: Combine PT & M2H

EXPERIMENTAL

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; Behavioral: Move 2 Health (M2H)

Phase II: MORE Mindfulness

EXPERIMENTAL

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

Interventions

Physical Therapy BEHAVIORAL

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).

Also known as: physiotherapy

Phase I: Physical Therapy (PT); Phase II: Combine PT & M2H

Move 2 Health (M2H) BEHAVIORAL

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.).

Phase I: Move to Health (M2H); Phase II: Combine PT & M2H

MORE Mindfulness BEHAVIORAL

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

Phase II: MORE Mindfulness

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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).
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (4)

Desmond Doss Health Clinic

Schofield Barracks, Hawaii, 96786, United States

Location

Brooke Army Medical Center

San Antonio, Texas, 78219, United States

Location

Wilford Hall Ambulatory Surgical Center

San Antonio, Texas, 78236, United States

Location

Madigan Army Medical Center

Tacoma, Washington, 98391, United States

Location

Related Publications (4)

• 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.

  PMID: 21451091 BACKGROUND

• 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.

  PMID: 20685078 BACKGROUND

• 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.

  PMID: 17909210 BACKGROUND

• 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.

  PMID: 34407840 DERIVED

Related Links

• VA/DoD Clinical Practice Guidelines for Diagnosis and Treatment of Low Back Pain (LBP) (2017)
• NIH-DoD-VA Pain Management Collaboratory

MeSH Terms

Conditions

Low Back Pain; Chronic Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Julie M Fritz, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

• Daniel I Rhon, PhD

  Brooke Army Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DSc, PT, Physical Performance Service Line, Office of the Surgeon General

Model Details: 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.

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: November 21, 2019
• Study Start: December 9, 2019
• Primary Completion: April 1, 2025
• Study Completion: July 1, 2025
• Last Updated: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Depends on the timeline established by the PMC
• 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.

Locations

US (4)