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

NCT ID: NCT04172038

Last Updated: 2025-01-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 850 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-09
• Study Completion Date: 2025-07-31

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.

Conditions

Low Back Pain; Chronic Pain; Military Personnel; Veterans

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Physical Therapy

Intervention Type: 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).

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.

Group Type: EXPERIMENTAL

Move 2 Health (M2H)

Intervention Type: 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 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.

Group Type: EXPERIMENTAL

Physical Therapy

Intervention Type: 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).

Move 2 Health (M2H)

Intervention Type: 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 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.

Group Type: EXPERIMENTAL

MORE Mindfulness

Intervention Type: 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

Interventions

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).

Intervention Type: 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.).

Intervention Type: 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

Intervention Type: BEHAVIORAL

Other Intervention Names

physiotherapy

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Madigan Army Medical Center

FED

Sponsor Role: collaborator

59th Medical Wing

FED

Sponsor Role: collaborator

Tripler Army Medical Center

FED

Sponsor Role: collaborator

Brooke Army Medical Center

FED

Sponsor Role: lead

Responsible Party

Dan Rhon

DSc, PT, Physical Performance Service Line, Office of the Surgeon General

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julie M Fritz, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Daniel I Rhon, PhD

Role: PRINCIPAL_INVESTIGATOR

Brooke Army Medical Center

Locations

Desmond Doss Health Clinic

Schofield Barracks, Hawaii, United States

Brooke Army Medical Center

San Antonio, Texas, United States

Wilford Hall Ambulatory Surgical Center

San Antonio, Texas, United States

Madigan Army Medical Center

Tacoma, Washington, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21451091 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20685078 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17909210 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34407840 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

https://www.healthquality.va.gov/guidelines/Pain/lbp/

VA/DoD Clinical Practice Guidelines for Diagnosis and Treatment of Low Back Pain (LBP) (2017)

https://painmanagementcollaboratory.org/smart-stepped-care/

NIH-DoD-VA Pain Management Collaboratory

Other Identifiers

4UH3AT009763-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

908761

Identifier Type: -

Identifier Source: org_study_id