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.

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 Overview

• Status: Not yet recruiting
• Conditions: Lumbago
• Intervention / Treatment: Procedure: High-Intensity Focused Ultrasound of the medial lumbar branch

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Carles Espinós, MD; Phone Number: +34 650125113; Email: md071683@uic.es

Study Locations

• Spain
  • Barcelona
    • Barcelona, Barcelona, Spain, 08036
      • Hospital Clinic De Barcelona
      • Contact: Cristina Rodriguez; Phone Number: +34 93 227 57 66; Email: ceic@clinic.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with mechanical low back pain without any other associated clinical features (neuropathic pain characteristics or significant suspicion of pain in other anatomical regions that may be causing the low back pain) who undergo lumbar medial branch ablation using the HIFU technique.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pacients with mechanical lumbalgia	Procedure: High-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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Consorci Sanitari de Terrassa
• Collaborators: Hospital Clinic of Barcelona

Publications and helpful links

General Publications

• -Sayed D, Grider J, Strand N, et al. The American Society of Pain and Neuroscience (ASPN) Evidence-Based Clinical Guideline of Interveneonal Treatments for Low Back Pain. Journal of Pain Research. 2022;15:3729-3832. doi:10.2147/JPR.S386879. -Park S, Park JH, Sokpeou N, et al. Radiofrequency Treatments for Lumbar Facet Joint Syndrome: A Systemaec Review and Network Meta-Analysis. Regional Anesthesia and Pain Medicine. 2024;:rapm-2024-105883. doi:10.1136/rapm-2024-105883. -Izadifar Z, Izadifar Z, Chapman D, Babyn P. An Introduceon to High Intensity Focused Ultrasound: Systemaec Review on Principles, Devices, and Clinical Applicaeons. Journal of Clinical Medicine. 2020;9(2):E460. doi:10.3390/jcm9020460. -Sayed D, Grider J, Strand N, et al. The American Society of Pain and Neuroscience (ASPN) Evidence-Based Clinical Guideline of Interveneonal Treatments for Low Back Pain. Journal of Pain Research. 2022;15:3729-3832. doi:10.2147/JPR.S386879. doi:10.2147/JPR.S386879. -Gofeld M, Tiennot T, Miller E, et al. Fluoroscopy-Guided High-Intensity Focused Ultrasound Ablaeon of the Lumbar Medial Branch Nerves: Dose Escalaeon Study and Comparison With Radiofrequency Ablaeon in a Porcine Model. Regional Anesthesia and Pain Medicine. 2025;50(5):429-436. doi:10.1136/rapm-2024-105417. -Kaye EA, Mone{e S, Srimathveeravalli G, et al. MRI-guided Focused Ultrasound Ablaeon of Lumbar Medial Branch Nerve: Feasibility and Safety Study in a Swine Model. Internaeonal Journal of Hyperthermia. 2016;32(7):786-94. doi:10.1080/02656736.2016.1197972. -Gofeld M, Smith KJ, Bhaea A, et al. Fluoroscopy-Guided High-Intensity Focused Ultrasound Neurotomy of the Lumbar Zygapophyseal Joints: A Prospeceve, Open-Label Study. Regional Anesthesia and Pain Medicine. 2025;50(6):464-470. do

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 8, 2026
• First Submitted That Met QC Criteria: March 8, 2026
• First Posted (Actual): March 12, 2026

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Chronic Pain; HIFU; Lumbalgia
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; Low Back Pain
• Other Study ID Numbers: HCB/2025/1189

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No