LumbagoNCT07467408
Treatment of Mechanical Low Back Pain With High-Intensity Focused Ultrasound (HIFU)
An observational study of Lumbago, run by Consorci Sanitari de Terrassa at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbago
- What is being tested?
- High-Intensity Focused Ultrasound of the medial lumbar branch
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2026to 31 Dec 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Coagulation disorders or thrombocytopenia.
- Vertebral fracture or compression at the treatment level.
- Medical condition contraindicating sedation or the treatment position.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Hospital Clinic de Barcelona
Barcelona, Barcelona, 08036
Cristina Rodriguez, +34 93 227 57 66, ceic@clinic.cat
About this study
Official title: Prospective Observational Study of the Treatment of Mechanical Low Back Pain With High-Intensity Focused Ultrasound (HIFU) of the Lumbar Medial Branch.
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
- Being tested
- High-Intensity Focused Ultrasound of the medial lumbar branch
- Keywords
- Chronic Pain, Lumbalgia, HIFU
- Medical subject headings
- Low Back Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Focused Ultrasound of the medial lumbar branchProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Pacients with mechanical lumbalgia | Pacients with mechanical lumbalgia Receives: Procedure: High-Intensity Focused Ultrasound of the medial lumbar branch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verbal Numerical Rate Scale
0 - 10 Verbal Numerical Rate Scale
Measured: 1, 3, 6 months
Secondary outcomes (3)
Oswestry Scale
Measured: 1, 3 and 6 months
Catastrophisme scale
Measured: 1, 3, 6 months
Brief Pain Inventory
Measured: 1, 3, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LumbagoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de Terrassa
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clinic of Barcelona
- Responsible party
- Principal investigator, Carles Espinos Ramírez, Consorci Sanitari de Terrassa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07467408
- Sponsor's protocol ID
- HCB/2025/1189
- Status last verified
- Mar 2026
- First submitted
- 8 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study of the Treatment of Mechanical Low Back Pain With High-Intensity Focused Ultrasound (HIFU) of the Lumbar Medial Branch.
- ClinicalTrials.gov ID
- NCT07467408
- Acronym / sponsor ID
- HCB/2025/1189
- Conditions
- Lumbago
- Keywords
- Chronic Pain, Lumbalgia, HIFU
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Consorci Sanitari de TerrassaUniversity, hospital or other
- Collaborators
- Hospital Clinic of Barcelona
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pacients with mechanical lumbalgia | – | Procedure: High-Intensity Focused Ultrasound of the medial lumbar branchPacients with mechanical lumbalgia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-Intensity Focused Ultrasound of the medial lumbar branchFocal 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. | Procedure or surgery | Pacients with mechanical lumbalgia |
Primary outcome
Verbal Numerical Rate Scale
Time frame: 1, 3, 6 months
0 - 10 Verbal Numerical Rate Scale
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- 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
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbago, run by Consorci Sanitari de Terrassa at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carles Espinós, MD (+34 650125113, md071683@uic.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verbal Numerical Rate Scale (time frame: 1, 3, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07467408, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.