About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- High-Intensity Focused Ultrasound of the medial lumbar branch
Treatment groups
Sponsors and collaborators
Consorci Sanitari de Terrassa
Lead sponsor
Hospital Clinic of Barcelona
Collaborator