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Clinical Trials in Spain / NCT07467408
Starting soon Observational

Treatment of Mechanical Low Back Pain With High-Intensity Focused Ultrasound (HIFU)

NCT07467408 · tracked via the Priya Life Science Spain tracker
Phase
Observational
Started
2026-04-01
Last updated
2026-03-16

Condition(s) studied

Lumbago

Investigational drug(s) / intervention(s)

High-Intensity Focused Ultrasound of the medial lumbar branch

High-Intensity Focused Ultrasound of the medial lumbar branch: Focal exposure, with a duration of 50 seconds and an energy output of 1000 joules. Monitoring of temperature and the patient's response is essential to avoid collateral damage. The objective is to achieve temperatures of 80-85 °C at the focus to induce thermal necrosis of the nerve.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hospital Clinic de Barcelona Barcelona Barcelona

More Consorci Sanitari de Terrassa trials in Spain

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07467408 on ClinicalTrials.gov ↗ ← All trials in Spain