Comparing Non-Medicine Strategies for Improving Low Back Pain

NCT07679178 | Not Yet Recruiting

• 2 other identifiers: Pro00120495BPS-2024-40339
• Study Type: interventional
• Target: 530
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Veterans; Low Back Pain; Clinical Pathway; Pain Management; Non-Pharmacologic

Outcome Measures

Primary Outcomes (1)

• Pain interference with normal activities as assessed by PROMIS (Patient-Reported Outcomes Measurement Information System) Short Form 8a v1.0 score

  The validated PROMIS Pain Interference instrument measures the self-reported consequences of pain across aspects of life including social, cognitive, emotional, physical, and recreational activities. The pain interference form asks the participant to rate a series of pain related questions on a scale of 1-5 within the past seven days with 1 representing a better outcome. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. A higher score indicates greater pain interference.

  From enrollment to 6 Months

Secondary Outcomes (7)

• Average Ratings of Self-Reported Sleep Quality

  Baseline to 6 Months

• Average Ratings of Self-Reported Physical Function

  Baseline to 6 Months

• Average Self-Reported Pain Intensity Ratings

  Baseline to 6 Months

• Average Self-Reported Endorsement of Depression Symptoms

  Baseline to 6 Months

• Average Self-Reported Endorsement of Anxiety Symptoms

  Baseline to 6 Months

Study Arms (2)

ENCompaSS + VA Usual Stepped Care

ACTIVE COMPARATOR

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.

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

VA Usual Stepped Care

NO INTERVENTION

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.

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.

ENCompaSS + VA Usual Stepped Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be age 18 years old or older
• Have a VA outpatient clinic visit for low back pain within the previous 30 days
• Be enrolled in a participating primary care clinic
• Have high impact chronic pain per Graded Chronic Pain Scale (most days or every day on first 2 items)
• Valid telephone access
• Ability to provide informed consent

You may not qualify if:

• Are currently hospitalized or residing in a nursing home
• Have cognitive impairment or lack of decision-making capacity
• Have a serious mental illness (e.g., schizophrenia, bipolar disorder, recent psychiatric hospitalization, high risk suicide flag)
• Are unable to communicate by telephone or have no telephone access

Sponsors & Collaborators

• Duke University: lead
• Durham VA Medical Center: collaborator
• Indiana University: collaborator
• University of Arizona: collaborator
• Dallas VA Medical Center: collaborator

Study Sites (1)

Durham VA

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Low Back Pain; Agnosia

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Susan Hastings, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 1, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): July 31, 2029
• Study Completion (Estimated): July 31, 2029
• Last Updated: July 28, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data and other resources referenced will be available one year after the date of publication for the primary analyses, which is in alignment with the VA Office of Research and Development.
• Access Criteria: We plan on using a de-identified dataset and is not subject to HIPAA's minimum necessary standards and would not require a data use agreement. Typically, datasets will be provided in SAS transport files using CDISC standards via a website. Requesters will have to enter a valid email, phone number and address to request data. The data provided will be made available under certain requirements and approved on a case-by-case basis. Requirements include: * Data will be used for research purposes and not to identify subjects * Data must be secured using appropriate computer technology * Data must be destroyed or returned after any analysis are complete authors of any manuscript resulting from this data must acknowledge the source of the data * Analyses for the purpose of presentations, abstracts, and/or publications must be coordinated through the Publications Committee, to avoid overlap * Coauthors must be given a chance for review and approval of a draft manuscript prior to submission

Locations

US (1)