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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Comparing Non-Medicine Strategies for Improving Low Back Pain
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Susan Hastings, MD · PRINCIPAL_INVESTIGATOR · Duke University
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- 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.