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

ConditionLumbago
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorConsorci Sanitari de Terrassa

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

60 Participants
are divided into 1 treatment group

Sponsors and collaborators

Consorci Sanitari de Terrassa

Lead sponsor

Hospital Clinic of Barcelona

Collaborator