Back to results

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

Primary Purpose

Low Back Pain, Chronic Pain, Military Personnel

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Physical Therapy

Move 2 Health (M2H)

MORE Mindfulness

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring stepped care, physical therapy, mindfulness, holistic health, military medicine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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)

Sites / Locations

Desmond Doss Health ClinicRecruiting
Brooke Army Medical CenterRecruiting
Wilford Hall Ambulatory Surgical CenterRecruiting
Madigan Army Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Phase I: Physical Therapy (PT)

Phase I: Move to Health (M2H)

Phase II: Combine PT & M2H

Phase II: MORE Mindfulness

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

PROMIS Physical Function Computer Adapted Test (PF-CAT)

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.

Full Information

NCT ID

NCT04172038

First Posted

November 18, 2019

Last Updated

July 14, 2023

Sponsor

Brooke Army Medical Center

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT04172038

Brief Title

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

Acronym

SMART LBP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 9, 2019 (Actual)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

September 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Brooke Army Medical Center

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain, Chronic Pain, Military Personnel, Veterans

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

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

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.

Allocation

Randomized

Enrollment

850 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Phase I: Physical Therapy (PT)

Arm Type

Experimental

Arm Description

Arm Title

Phase I: Move to Health (M2H)

Arm Type

Experimental

Arm Description

Arm Title

Phase II: Combine PT & M2H

Arm Type

Experimental

Arm Description

Arm Title

Phase II: MORE Mindfulness

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Physical Therapy

Other Intervention Name(s)

physiotherapy

Intervention Description

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

Intervention Name(s)

Move 2 Health (M2H)

Intervention Description

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: Sleep Physical Activity Nutrition Intrinsic Well-Being (Personal Development, Spiritual Well-Being, Emotional Well-Being) 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

Intervention Name(s)

MORE Mindfulness

Intervention Description

Throughout the intervention, three core areas are emphasized. Activities include exercises and at-home work for participants to reinforce these core areas. Mindfulness Cognitive reappraisal Savoring of positive experiences

Primary Outcome Measure Information:

Title

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

Description

Time Frame

1 year

Secondary Outcome Measure Information:

Title

PROMIS Physical Function Computer Adapted Test (PF-CAT)

Description

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mary Laugesen, DPT

Phone

210-808-2575

mary.c.laugesen.ctr@mail.mil

First Name & Middle Initial & Last Name or Official Title & Degree

Rachel Mayhew, DPT

rachel.J.mayhew.ctr@mail.mil

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Julie M Fritz, PhD

Organizational Affiliation

University of Utah

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Daniel I Rhon, DSc

Organizational Affiliation

Brooke Army Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Desmond Doss Health Clinic

City

Schofield Barracks

State/Province

Hawaii

ZIP/Postal Code

96786

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hannah Buckingham, DPT

hannah.c.buckingham.ctr@mail.mil

First Name & Middle Initial & Last Name & Degree

Garry Dredge, DPT

Facility Name

Brooke Army Medical Center

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78219

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mary Laugesen, DPT

Phone

210-808-2575

mary.c.laugesen.ctr@mail.mil

First Name & Middle Initial & Last Name & Degree

Bryan Pickens, DSc

Facility Name

Wilford Hall Ambulatory Surgical Center

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78236

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mariah Callas, DPT

mariah.j.callas.ctr@mail.mil

First Name & Middle Initial & Last Name & Degree

Fern Daniels, DPT

Facility Name

Madigan Army Medical Center

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98391

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rachel J Mayhew, DPT

rachel.J.mayhew.ctr@mail.mil

First Name & Middle Initial & Last Name & Degree

Brian Hatler, DPT

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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 URL

https://painmanagementcollaboratory.org/

Citations:

PubMed Identifier

21451091

Citation

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.

Results Reference

background

PubMed Identifier

20685078

Citation

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.

Results Reference

background

PubMed Identifier

17909210

Citation

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. Erratum In: Ann Intern Med. 2008 Feb 5;148(3):247-8.

Results Reference

background

PubMed Identifier

34407840

Citation

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.

Results Reference

derived

Links:

URL

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

Description

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

URL

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

Description

NIH-DoD-VA Pain Management Collaboratory

Learn more about this trial

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

We'll reach out to this number within 24 hrs