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Stepped Care Management for Lower Back Pain (SMART LBP Trial)

N/A

Recruiting

Led By Julie M Fritz, PhD

Research Sponsored by Brooke Army Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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).

Age 18 - 65 years at the time of enrollment.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

SMART LBP Trial Summary

This trial will study two possible treatments for chronic low back pain, physical therapy or Move 2 Health. If neither of these treatments work after six weeks, patients will then be randomized to receive either the addition of the other treatment or the MORE Mindfulness intervention.

Who is the study for?

This trial is for active duty military, reservists on active duty, their family members, or Tricare beneficiaries with chronic low back pain. Participants must be aged 18-65 and able to attend treatment sessions over a 16-week period. Exclusions include recent lumbar spine surgery, pending military discharge for medical reasons, serious causes of back pain like fractures or neoplasms, pregnancy, and certain treatments received in the past 6 months.Check my eligibility

What is being tested?

The study tests two initial treatments for chronic low back pain: physical therapy or Move 2 Health (M2H). Those not improving after six weeks enter Phase II where they either add the other initial treatment they didn't receive or start MORE Mindfulness intervention. The process involves random assignment and participants are monitored for one year.See study design

What are the potential side effects?

While specific side effects aren't listed here as it's more about management strategies than medications; potential side effects may include muscle soreness from physical therapy exercises and emotional discomfort when engaging in mindfulness practices if underlying psychological issues surface.

SMART LBP Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have lower back pain or a related condition.

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I am between 18 and 65 years old.

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I have had lower back pain for more than 3 months and it's been frequent in the last 6 months.

SMART LBP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

PROMIS Physical Function Computer Adapted Test (PF-CAT)

SMART LBP Trial Design

4Treatment groups

Experimental Treatment

Group I: Phase II: MORE MindfulnessExperimental Treatment1 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.

Group II: Phase II: Combine PT & M2HExperimental Treatment2 Interventions

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 III: Phase I: Physical Therapy (PT)Experimental Treatment1 Intervention

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 IV: Phase I: Move to Health (M2H)Experimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Physical Therapy

2020

Completed Phase 4

~1460

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of UtahOTHER

1,099 Previous Clinical Trials

1,777,839 Total Patients Enrolled

National Center for Complementary and Integrative Health (NCCIH)NIH

832 Previous Clinical Trials

668,123 Total Patients Enrolled

Madigan Army Medical CenterFED

48 Previous Clinical Trials

17,354 Total Patients Enrolled

Media Library

Move 2 Health (M2H) Clinical Trial Eligibility Overview. Trial Name: NCT04172038 — N/A

Lower Back Pain Research Study Groups: Phase I: Physical Therapy (PT), Phase II: MORE Mindfulness, Phase II: Combine PT & M2H, Phase I: Move to Health (M2H)

Lower Back Pain Clinical Trial 2023: Move 2 Health (M2H) Highlights & Side Effects. Trial Name: NCT04172038 — N/A

Move 2 Health (M2H) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04172038 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How might I qualify for participation in this investigation?

"This medical trial is seeking to recruit 1200 veterans aged 18-65. To be eligible, participants must meet the following criteria: they must have an active duty status in the Army, Navy, Air Force or Marines; a family member of such personnel; Tricare beneficiary receiving treatment at a relevant facility; and chief complaint of LBP with ICD 10th edition codes as listed above. Furthermore, they need to have had this issue for longer than 3 months over the past 6 months and anticipate their ability to attend 16 weeks worth of sessions afterwards without any two-week absences due to training or vacation among other reasons."

Answered by AI

Is this experimental research currently recruiting participants?

"This experimental trial, which was conceived on December 9th 2019 and revised most recently on July 13th 2022, is actively seeking study participants."

Answered by AI

Is the eligibility criteria for this investigation restricted to individuals 30 years of age and younger?

"Patients aged 18 to 65 are eligible for this clinical trial. Additionally, there are 44 trials that accommodate minors and 614 devoted exclusively to those beyond the age of retirement."

Answered by AI

What is the total number of participants currently being recruited for this medical experiment?

"The total number of participants required for this research is 1,200 individuals that meet the necessary criteria. Brooke Army Medical Center in San Antonio, Texas and Wilford Hall Ambulatory Surgical Center in Tacoma, Washington are two sites where patients can take part in the study."

Answered by AI