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

N/A

Waitlist Available

Led By Daniel I Rhon, 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.

Must not have

Signs of serious or systemic pathology as a cause of LBP including spine fracture, neoplasm, inflammatory disease (e.g., ankylosing spondylitis), vertebral osteomyelitis, etc.

Has received any lumbar spine surgery in the past year.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My lower back pain is not due to a serious condition like a fracture or cancer.

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I have had surgery on my lower back in the last year.

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I have seen specialists or had therapy for lower back pain in the last 6 months.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

PROMIS Physical Function Computer Adapted Test (PF-CAT)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1280

0 / 6Eligibility criteria met