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

Prospective Observational Study of the Treatment of Mechanical Low Back Pain With High-Intensity Focused Ultrasound (HIFU) of the Lumbar Medial Branch.

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07467408

Enrollment

Registered

2026-03-12

Start date

2026-04-01

Completion date

2026-12-31

Last updated

2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbago

Keywords

Chronic Pain, Lumbalgia, HIFU

Brief 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.

Interventions

PROCEDUREHigh-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 design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Verbal Numerical Rate Scale	1, 3, 6 months	0 - 10 Verbal Numerical Rate Scale

Secondary

Measure	Time frame
Catastrophisme scale	1, 3, 6 months
Brief Pain Inventory	1, 3, 6 months
Oswestry Scale	1, 3 and 6 months

Countries

Spain

Contacts

CONTACTCarles Espinós, MD

md071683@uic.es+34 650125113

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026