What this study is
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
What's being tested
- ENCompaSS (Education, Navigated Care, and Supported Self-Management) with VA Stepped Usual Care
Intervention · 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
- Official title
- Comparing Strategies to Improve Non-Pharmacologic Pain Relief for Adults With Back Pain (The ENCompaSS Trial)
- Sponsor
- Duke University
- Conditions
- Chronic Low-back Pain (cLBP) · High-Impact Chronic Pain (HICP)
- Enrolling
- 530 people
- Starts
- 2026-12
- Est. completion
- 2029-07-31
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou 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 can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openDurham VA
Durham, North Carolina, United States
Study team
Sponsor
Duke University
Study ID Pro00120495
Principal investigator
Susan Hastings, MD
Duke University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.