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

Consorci Sanitari de Terrassa

Status

Not yet enrolling

Conditions

Lumbago

Treatments

Procedure: High-Intensity Focused Ultrasound of the medial lumbar branch

Study type

Observational

Funder types

Other

Identifiers

NCT07467408

HCB/2025/1189

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.