Intracept Minimally-invasive PROcedure for VErtebrogenic Back Pain (NCT06827262) | Clinical Trial Compass
RecruitingNot Applicable
Intracept Minimally-invasive PROcedure for VErtebrogenic Back Pain
United States1,500 participantsStarted 2025-03-26
Plain-language summary
Compile real-world outcomes of commercially approved Intracept™ Intraosseous Nerve Ablation Systems in the treatment of patients diagnosed with vertebrogenic pain.
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:
* Study candidate is scheduled to be treated with a commercially approved Intracept™ Intraosseous Nerve Ablation System per local Instructions for Use (IFU).
* Signed a valid, IRB/EC-approved informed consent form.
Exclusion Criteria:
* Meets any contraindications per locally applicable Instructions for Use (IFU).
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 studying the Intracept procedure for vertebrogenic back pain specifically — how would my doctor determine whether my chronic low back pain is actually vertebrogenic in origin, and would I need any special imaging or testing to find out?
2Since this trial is listed as 'Phase NA,' which often means it's evaluating a device or procedure rather than following the usual drug trial phases, what does that mean for how much is already known about the safety and effectiveness of the Intracept procedure before I consider participating?
3The main thing this trial is measuring is change in disability using the Oswestry Disability Index — can my doctor explain what that score looks like in practice, and what kind of improvement would actually be meaningful for my day-to-day life?
4Before looking at a trial like this, should I first try or exhaust standard treatments for chronic low back pain — like physical therapy, medications, or injections — and how would my doctor weigh those options against pursuing the Intracept procedure through this study?
5If I were to discuss this trial with my care team, what would the follow-up schedule look like, and are there any restrictions on other treatments or activities I'd need to follow while participating?
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
Change in Disability (Oswestry Disability Index (ODI) from Baseline