Comparing Non-Medicine Strategies for Improving Low Back Pain

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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

Key Dates

First listed

Jul 1, 2026

Start date

Oct 31, 2026

Status verified

Jun 2026

Primary completion

Jul 31, 2029

Completion

Jul 31, 2029

Study Design

Enrollment

530 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: ENCompaSS + VA Usual Stepped Care
  The ENCompaSS trial builds on pain navigation and management by integrating: * Structured pain education * Shared decision making using the OPTIONS decision aid * Facilitated referrals to preferred non pharmacologic treatments * Supported self-management (goal setting, problem solving, self-efficacy) * Asynchronous educational videos and optional SMS communication Veterans randomized to ENCompaSS receive at least three structured navigator-led phone sessions over 12 weeks, delivered by trained clinicians (e.g., nurses, physical therapists, health coaches) using existing VA resources.
• No Intervention: VA Usual Stepped Care
  Participants randomized to VA usual stepped care alone will receive standard pain treatment available within the Veterans Health Administration (VHA) as directed by their treating provider and guided by the Stepped Care Model for Pain Management (SCM-PM). The SCM-PM, a tiered framework implemented system-wide through VHA Directive 2009-053, begins with the least intensive and most accessible treatments, progressing to more specialized and intensive interventions as needed. Key components include initial assessment and management in primary care, with referrals to specialists in pain medicine, physical medicine, rehabilitation, and behavioral health when primary care interventions are insufficient. VA usual stepped care participants will receive study materials to orient them to their treatment arm and provide assessment at multiple time points but will not receive any specific information or intervention related to LBP other than what normally would be provided.

Primary Outcome Measure

Pain interference with normal activities as assessed by PROMIS (Patient-Reported Outcomes Measurement Information System) Short Form 8a v1.0 score [ Time Frame: From enrollment to 6 Months ]

Locations (1)

Find similar trials in Durham, NC

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