ClinicalTrials.gg
Not yet recruitingNCT07467408Updated Mar 16, 2026

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

An observational study in Lumbago, sponsored by Consorci Sanitari de Terrassa. Not yet recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-16.

Sponsored by Consorci Sanitari de Terrassa · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 168 studies in Low Back Pain with a site in Spain — 20 open to participants now, 22 under way, 1 of them phase 3. Low Back Pain · Spain.

Planned enrollment
17th of 20
60 · median 137
Started
2026
with 7 others
Observational
20 of 168
3 open now
Primary completion
2026-12
later than 14 of 21 live
Registered
163rd of 168
by date

Among the 168 studies in Low Back Pain with a site in Spain, this one is the 17th largest by planned enrollment of the 20 observational ones, is one of 8 that started in 2026, is one of 20 observational ones, reaches primary completion later than 14 of the 21 other live ones, and was the 163rd registered.

By phase

168 studies; the count open now beside each. This study's row is marked.

No phase131 · 17 open
Observationalthis study20 · 3 open
Phase 25 · 0 open
Phase 34 · 0 open
Phase 13 · 0 open
Phase 1/22 · 0 open
Phase 42 · 0 open
Phase 2/31 · 0 open

By the year they started

First in 2005; this study’s year is marked. 8 started in 2026.

Size and results

Median enrollment 60 across the 148 interventional studies, 137 across the 20 observational. Of the 121 that completed or were terminated, 9 (7%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 168 studies in Low Back Pain with a site in Spain, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Lumbago

Keywords

  • Chronic Pain
  • Lumbalgia
  • HIFU
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Over 18 years of age.
  • Signed 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

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, 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • Pacients with mechanical lumbalgia

    Pacients with mechanical lumbalgia

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

Interventions

  • ProcedureHigh-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.

06

What researchers measure

Primary outcomes

  1. Verbal Numerical Rate Scale

    0 - 10 Verbal Numerical Rate Scale

    Time frame: 1, 3, 6 months

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

07

Study locations

1 site
08

References and documents

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 documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Apr 2026; primary completion for Dec 2026, 8 months later.

Of 175 non-industry observational studies under Low Back Pain, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 48. This study's planned 8 months is below that.

Counting every sponsor, half of 185 studies reached it within 24 months; a quarter within 10 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 8, 2026
First posted
Mar 12, 2026
StartEst.
Apr 1, 2026
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Mar 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07467408
Lead sponsor
Consorci Sanitari de Terrassa
Responsible party
Carles Espinos Ramírez (Principal Investigator, Consorci Sanitari de Terrassa) — Principal investigator
First posted
Mar 12, 2026
Start date
Apr 1, 2026 (estimated)
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Mar 16, 2026

Study contacts

Carles Espinós, MD
Contact
md071683@uic.es
+34 650125113

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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