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| Name | Class |
|---|---|
| Hospital Clinic of Barcelona | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pacients with mechanical lumbalgia | Pacients with mechanical lumbalgia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Verbal Numerical Rate Scale | 0 - 10 Verbal Numerical Rate Scale | 1, 3, 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Oswestry Scale | 1, 3 and 6 months | |
| Catastrophisme scale | 1, 3, 6 months | |
| Brief Pain Inventory |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carles Espinós, MD | Contact | +34 650125113 | md071683@uic.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic de Barcelona | Barcelona | Barcelona | 08036 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | -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 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 28, 2025 | Mar 8, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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|
| 1, 3, 6 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |