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NCT07679178
Comparing Non-Medicine Strategies for Improving Low Back Pain
Conditions: Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 530
Sponsor: Duke University
Location: Durham VA Durham North Carolina
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
Eligibility Criteria
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Source: ClinicalTrials.gov (NCT07679178). StuddyBuddy aggregates publicly available trial information.