Neurolyser XR for Low Back Pain

Overseen By Alexi Moruza

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: FUSMobile Inc.

Must not be taking: Anti-arrhythmics, High-dose opioids

Disqualifiers: Dialysis, Radiculopathy, Pregnancy, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the use of the Neurolyser XR device, which employs focused ultrasound to target and treat nerve pain in individuals with sacroiliitis, a condition causing chronic lower back pain. The goal is to determine if this treatment can effectively reduce pain by disrupting nerve signals with ultrasound. It suits those who have experienced chronic lower back pain for at least a year, particularly if the pain is centered below the L5 vertebra and not due to other causes like a herniated disc or surgery. As an unphased trial, this study provides an opportunity to contribute to innovative research that could lead to new treatment options for chronic pain sufferers.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are taking more than 60 milligrams of morphine equivalents per day, you may not be eligible to participate.

What prior data suggests that the Neurolyser XR device is safe for treating Sacroiliitis?

Research has shown that the Neurolyser XR, which uses a special type of ultrasound, has promising safety results. This method works similarly to radiofrequency ablation, a well-known technique. The Neurolyser XR has received a CE Mark in Europe, indicating it meets safety standards for treating certain chronic low back pain.

Some studies have examined the safety and practicality of this ultrasound method. Although detailed results are not widely available, the device's approval in Europe suggests it is safe. Overall, data indicates that the Neurolyser XR is generally well-tolerated, with no major safety concerns reported so far. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Neurolyser XR is unique because it uses high-intensity focused ultrasound (HIFU) to target and relieve low back pain associated with sacroiliitis. Unlike other treatments that might involve medication, injections, or surgery, this method uses precise ultrasound waves to disrupt nerve function, potentially reducing pain without drugs or invasive procedures. Researchers are excited about this treatment because it offers a non-invasive alternative that could provide pain relief with fewer side effects and a quicker recovery time compared to traditional options.

What evidence suggests that the Neurolyser XR device is effective for Sacroiliitis?

Research has shown that the Neurolyser XR, which uses focused sound waves, effectively treats low back pain caused by sacroiliitis. In this trial, participants will receive high-intensity focused ultrasound delivered to the lateral sacral branch nerve for neurolysis. Studies indicate that this device provides pain relief similar to radiofrequency ablation, a well-known treatment for nerve pain. The Neurolyser XR targets sound wave energy directly at the painful nerve to help reduce pain. Importantly, this device has received the CE Mark, indicating it is recognized as safe and effective for treating chronic low back pain in Europe. These findings suggest that the Neurolyser XR could be a promising option for managing back pain related to sacroiliitis. ^{1 2 3 6 7}

Who Is on the Research Team?

Lynn Kohan, MD

Principal Investigator

University of Virginia Pain Medicine Clinic

Are You a Good Fit for This Trial?

This trial is for adults with chronic low back pain specifically due to Sacroiliitis, who've had some relief from SI joint injections or lateral branch blocks. Participants must have ruled out other causes of back pain and be able to communicate and comply with study requirements. They should also have a significant level of pain despite previous treatments.

Inclusion Criteria

You must be able to verbally interact with the doctor.

I can consent to the study and attend all visits.

My back pain is mainly below the waist.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

High-intensity focused ultrasound delivered to the lateral sacral branch nerve for neurolysis

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Neurolyser XR

Trial Overview The Neurolyser XR device is being tested in this trial. It uses high-intensity focused ultrasound to target nerves associated with Sacroiliitis-related low back pain, aiming to provide relief by ablating the lateral sacral branch nerve.

How Is the Trial Designed?

Group I: HIFU for Sacroiliitis Experimental Treatment 1 Intervention

High-intensity focused ultrasound delivered to the lateral sacral branch nerve for neurolysis.

Who Is Running the Clinical Trial?

FUSMobile Inc.

Lead Sponsor

Trials

7

Recruited

170+

Focused Ultrasound Foundation

Collaborator

Trials

18

Recruited

460+

Citations

1. fusfoundation.org fusfoundation.org/posts/low-back-pain-clinical-data-show-focused-ultrasound-is-safe-and-effective/

Low Back Pain: Clinical Data Show Focused Ultrasound is ... The Neurolyser XR HIFU system achieved clinical responses comparable with radiofrequency ablation. FUSMobile, a high-intensity focused ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06053255

Use of the Neurolyser XR for the Treatment of Low Back ... The Neurolyser XR is a device used to deliver high-intensity focused ultrasound for the ablation of the lateral sacral branch nerve in patients with ...

3. fusfoundation.org fusfoundation.org/posts/focused-ultrasound-device-for-low-back-pain-granted-ce-mark/

Focused Ultrasound Device for Low Back Pain Granted CE ... Key Points. FUSMobile's Neurolyser XR device has been granted the CE Mark for the treatment of a common cause of chronic low back pain.

4. trialx.com trialx.com/clinical-trials/listings/298389/use-of-the-neurolyser-xr-for-the-treatment-of-low-back-pain-related-to-sacroiliitis/

Use of the Neurolyser XR for the Treatment of Low Back ... The HIFU device used in this study is called, the Neurolyser XR. It focuses sound wave energy directly on the nerve of the painful sacroiliac ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05154448

Double Arm Pivotal Study to Evaluate the Neurolyser XR ... Individual presenting with a) a positive (>80% pain relief) to a previous, double, lumbar medial branch block (within the last 12 months) and/or b) with a ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05396495

Safety and Feasibility of the NeurolyserXR for Sacroiliac ... ... High Intensity Focused Ultrasound delivered by the Neurolyser XR. ... Neurolyser XR Device for the Treatment of Sacroiliac Joint Related Low Back Pain.

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04129034/safety-and-initial-feasibility-of-using-the-neurolyser-xr-device-for-the-treatment-of-axial-chronic-low-back-pain

Safety and Initial Feasibility of Using the Neurolyser XR ... Single arm pilot study to evaluate the safety and initial feasibility of the Neurolyser XR, a high intensity focused ultrasound device, ...