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

NCT07467408 | Not Yet Recruiting

• 1 other identifier: HCB/2025/1189
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbago

Keywords

Chronic Pain; Lumbalgia; HIFU

Outcome Measures

Primary Outcomes (1)

• Verbal Numerical Rate Scale

  0 - 10 Verbal Numerical Rate Scale

  1, 3, 6 months

Secondary Outcomes (3)

• Oswestry Scale

  1, 3 and 6 months

• Catastrophisme scale

  1, 3, 6 months

• Brief Pain Inventory

  1, 3, 6 months

Study Arms (1)

Pacients with mechanical lumbalgia

Pacients with mechanical lumbalgia

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

Interventions

High-Intensity Focused Ultrasound of the medial lumbar branch PROCEDURE

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.

Pacients with mechanical lumbalgia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Consorci Sanitari de Terrassa: lead
• Hospital Clinic of Barcelona: collaborator

Study Sites (1)

Hospital Clinic de Barcelona

Barcelona, Barcelona, 08036, Spain

Location

Related Publications (1)

• -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

  BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Carles Espinós, MD

CONTACT

+34 650125113; md071683@uic.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 8, 2026
• First Posted: March 12, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

ES (1)