Treatment of Mechanical Low Back Pain With High-Intensity Focused Ultrasound (HIFU)
Not yet recruitingNCT07467408
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Prospective Observational Study of the Treatment of Mechanical Low Back Pain With High-Intensity Focused Ultrasound (HIFU) of the Lumbar Medial Branch.
- Conditions
- Lumbago
- Interventions
- Procedure: High-Intensity Focused Ultrasound of the medial lumbar branch
- Sponsor
- Consorci Sanitari de Terrassa
- Collaborators
- Hospital Clinic of Barcelona
- Start date
- 2026-04-01
- Primary completion
- 2026-12-31
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Spain
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07467408