Treatment of Mechanical Low Back Pain With High-Intensity Focused Ultrasound (HIFU)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High-Intensity Focused Ultrasound of the medial lumbar branch.
- Who it may be relevant to
- Registry conditions: Lumbago. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Prospective Observational Study of the Treatment of Mechanical Low Back Pain With High-Intensity Focused Ultrasound (HIFU) of the Lumbar Medial Branch.
Overview
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
- 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.
Primary outcome measures
- Verbal Numerical Rate Scale [Time frame: 1, 3, 6 months]
Secondary outcome measures (3)
- Oswestry Scale [Time frame: 1, 3 and 6 months]
- Catastrophisme scale [Time frame: 1, 3, 6 months]
- Brief Pain Inventory [Time frame: 1, 3, 6 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Spain · 1 center
- Hospital Clinic de Barcelona — Barcelona
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 Anesthesi
Identifiers
NCT: NCT07467408 · HCB/2025/1189