Comparing Non-Medicine Strategies for Improving Low Back Pain (NCT07679178) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Comparing Non-Medicine Strategies for Improving Low Back Pain
United States530 participantsStarted 2026-10
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing non-medicine strategies for chronic low back pain — can you help me understand what kinds of non-drug approaches are likely being tested, and whether any of them would fit into my current treatment plan?
2The trial isn't recruiting yet, so if I'm interested, how long might I realistically have to wait before I could even apply, and what should I be doing in the meantime to manage my pain?
3The trial measures success using something called the PROMIS Short Form 8a score, which tracks how much pain interferes with normal daily activities — based on where I am right now with my functioning, do you think that's a meaningful goal for me to be working toward?
4Since this is listed as Phase NA, which often applies to behavioral or non-drug studies, what does that mean for how much is already known about the safety and effectiveness of whatever strategies they're testing compared to options I could start now?
5Given that this trial focuses on high-impact chronic pain as well as general low back pain, do you think my level of pain and its effect on my daily life puts me in a category where a non-medicine approach like this could realistically help, or would you recommend a different path first?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain interference with normal activities as assessed by PROMIS (Patient-Reported Outcomes Measurement Information System) Short Form 8a v1.0 score