Treatment of Mechanical Low Back Pain With High-Intensity Focused Ultrasound (HIFU) (NCT07467408) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Treatment of Mechanical Low Back Pain With High-Intensity Focused Ultrasound (HIFU)
Spain60 participantsStarted 2026-04-01
Plain-language summary
High-intensity focused ultrasound (HIFU) is an emerging technology that allows for the targeted thermal ablation of deep tissues in a non-invasive manner, by concentrating acoustic energy on the target nerve, whilst preserving adjacent structures. Recently, open clinical studies have confirmed the feasibility, safety and efficacy of HIFU in patients with lumbar facet syndrome, with clinical response rates similar to those of RFA and no significant complications.
This observational, prospective, non-interventional study aims to evaluate the clinical efficacy of lumbar medial branch ablation using this technique at 1, 3 and 6 months, as well as to assess patient satisfaction with the procedure. Only clinical data from patients undergoing the procedure in routine clinical practice will be collected.
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:
* Over 18 years of age.
* Signed informed consent for data collection.
* Mechanical low back pain with a positive diagnostic block (\>30% pain reduction) of the lumbar medial ramus with local anaesthetic.
Exclusion Criteria:
* Presence of pain with mixed characteristics or suspected multiple aetiology of the low back pain (e.g. sacroiliac joint involvement).
* Active systemic infection.
* Pregnancy.
* History of spinal surgery at the level of treatment.
* Presence of tumours, metastatic disease or osteoporosis in the treatment area.
* Pacemaker or implantable generator carriers.
* Coagulation disorders or thrombocytopenia.
* Vertebral fracture or compression at the treatment level.
* Medical condition contraindicating sedation or the treatment position.
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.