Comparing Non-Medicine Strategies for Improving Low Back Pain

This study is for veterans experiencing chronic low back pain, especially if it significantly impacts their daily life (high-impact chronic pain). It's testing a program called ENCompaSS (Education, Navigated Care, and Supported Self-Management) to see if it helps reduce pain more effectively than standard care. You would be randomly assigned to either the ENCompaSS program, which includes phone calls with a clinician and online videos, or to receive usual care. Researchers want to see how much ENCompaSS helps with pain interference in normal activities after six months. The study aims to enroll 530 veterans, but its current recruitment status is unclear.

Study design
This is an interventional study that will randomly assign 530 veterans to one of two groups: the ENCompaSS program or usual stepped care.
What's involved
If you join the ENCompaSS group, you will have at least three phone calls with a clinician over about 12 weeks and watch short online videos. You will also complete surveys at enrollment and again at 2, 4, 6, and 12 months.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for 12 months after being randomly assigned to a group, with the primary outcome measured at 6 months.

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NCT07679178

Comparing Non-Medicine Strategies for Improving Low Back Pain

Not Yet Recruiting
NAAges 18+InterventionalTreatment
Duke University
~530 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:ENCompaSS (Education, Navigated Care, and Supported Self-Management) with VA Stepped Usual Care

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pain interference with normal activities as assessed by PROMIS (Patient-Reported Outcomes Measurement Information System) Short Form 8a v1.0 score
Measured over From enrollment to 6 Months
Chronic Low-back Pain (cLBP)
High-Impact Chronic Pain (HICP)
1 sites across 1 states
North Carolina1
  • Susan Hastings, MD · PRINCIPAL_INVESTIGATOR · Duke University

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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
  • Pain interference with normal activities as assessed by PROMIS (Patient-Reported Outcomes Measurement Information System) Short Form 8a v1.0 scoreFrom enrollment to 6 Months

    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.