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Sound waves instead of needles: new device targets back pain without piercing skin

NCT ID NCT07647757

Symptom relief Sponsor: Federico II University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This trial investigates whether a device called Neurolyser XR can safely ease low back pain caused by sacroiliitis (inflammation of the joint at the base of the spine). The device uses high-intensity focused ultrasound to block pain signals from the joint, without needles or cutting the skin. About 30 adults with long-term sacroiliac joint pain will receive the treatment, and researchers will measure changes in pain levels.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
high intensity focused ultrasound (Neurolyser XR device)
What this could lead to
If it works, this could offer a needle-free, low-discomfort option for people with chronic low back pain from sacroiliitis.
What could go wrong
This is a small, early-stage study with only 30 participants. The device may not provide lasting pain relief, and risks like unintended tissue damage are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adult males and females, legally able and willing to participate in the study and come for follow-up visits * Able and willing to fill the research questionnaires and to communicate with investigator and research team * Patient with bilateral or unilateral sacroiliac joint pain of \> 6 months duration * Patients presenting with a) a positive (\>70% pain relief) to a previous nerve ablation procedure of the sacroiliac joint and / or b) with a positive (\>70% pain relief) to a previous nerve block procedure of the sacroiliac joint within the last six months) * Average pain score of 4 or higher in the last month, (on 0-10 scale). Exclusion Criteria: * Pregnant or breastfeeding patient * Patients presenting with neurological deficits (including lumbosacral radiculopathy but not solitary radicular pain). * Patients with history of lumbar and / or sacral spine surgery * Patients with the presence of metal hardware at the lumbosacral spine * Patients with history of pelvic pathology that may increase procedural risk and / or influence symptoms and / or generate unrelated adverse event (per the discretion of the study principal investigator) * Patients unable to understand and complete the research questionnaires in Italian. * Patients presenting with any severe medical condition preventing the patient from safely and effectively being treated in the study or reporting study outcome. * Patient with extensive scarring in the skin and tissue overlying the treatment area. * Patients enrolled in or planned to be enrolled in another clinical trial during the duration of this research project.

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Conditions

The condition(s) this trial relates to.

arthritis, sacroiliac Low Back Pain Sacroiliitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Low back pain Sacroiliitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Neuroscience, Reproductive and Odontostomatological Sciences

    Naples, 80131, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.