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Comparing Non-Medicine Strategies for Improving Low Back Pain

NCT07679178 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 530

Last updated 2026-07-28

No results posted yet for this study

Summary

The goal of this clinical trial is to help veterans manage high-impact chronic pain (HICP) in the lower back. The trial will use a program, ENCompaSS (Education, Navigated Care, and Supported Self-Management) designed to reduce pain more than usual care alone. Researchers will assess a) the impact of ENCompaSS, b) identify which veterans benefit the most, and c) how this program can be delivered more broadly in other clinics and health systems.

What Will Happen:

Veterans in this clinical trial will be randomly placed into one of two groups.

ENCompaSS group (intervention):

* Have at least three phone calls with a trained clinician over about 12 weeks
* Watch short online videos about managing pain
* Complete surveys before the study and again at 2, 4, 6, and 12 months

Usual Stepped Care group:

* Will continue with regular care
* Complete the same surveys at the same time points

Conditions

  • Chronic Low-back Pain (cLBP)
  • High-Impact Chronic Pain (HICP)

Interventions

OTHER

ENCompaSS (Education, Navigated Care, and Supported Self-Management) with VA Stepped Usual Care

The ENCompaSS pain program was designed based on the Chronic Care Model (CCM), a widely used framework for organizing care for people with chronic diseases. In this model, the care provided for low back pain (LBP) meeting criteria for high-impact chronic pain (HICP), intentionally brings together the patient, provider, and system interventions necessary to accomplish the overall goal of improving pain outcomes and related co-morbidities. Our previous experiences with navigation in a previous study were only partially represented in the CCM. ENCompaSS employs a more comprehensive blend of CCM elements, incorporating important domains such Self-Management Support, which we posit will result in better pain interference outcomes.

Sponsors & Collaborators

  • Durham VA Medical Center

    collaborator FED

  • Indiana University

    collaborator OTHER

  • University of Arizona

    collaborator OTHER

  • Dallas VA Medical Center

    collaborator FED

  • Duke University

    lead OTHER

Principal Investigators

  • Susan Hastings, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2029-07-31
Completion
2029-07-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07679178 on ClinicalTrials.gov