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NCT Number: NCT07467408

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

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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Key information

Conditions

Lumbago Back Pain Chronic Pain Low Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Verbal Numerical Rate Scale

    Time frame: 1, 3, 6 months

    0 - 10 Verbal Numerical Rate Scale

Secondary outcomes

  1. Oswestry Scale

    Time frame: 1, 3 and 6 months

  2. Catastrophisme scale

    Time frame: 1, 3, 6 months

  3. Brief Pain Inventory

    Time frame: 1, 3, 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Carles Espinós, MD

CONTACT

[email protected]

+34 650125113

Sponsors and collaborators

Lead sponsor

Consorci Sanitari de Terrassa

Other

Collaborators

  • Hospital Clinic of Barcelona

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 12, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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