30 Participants Needed

Safety and Initial Feasibility of Using the Neurolyser XR Device for the Treatment of Axial Chronic Low Back Pain

Recruiting at 4 trial locations
MG
Overseen ByMichael Gofeld, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are receiving active treatment for rheumatologic diseases with steroids, disease-modifying drugs, biological agents, or immunosuppressants, you may not be eligible to participate.

What safety data exists for Neurolyser XR or similar treatments?

The research articles do not provide specific safety data for Neurolyser XR or similar treatments. They discuss general adverse drug reactions and safety data management but do not mention Neurolyser XR or its safety profile.12345

How is the drug Neurolyser XR different from other treatments for this condition?

Neurolyser XR may be unique because it potentially targets nicotinic acetylcholine receptors (nAChRs), which are involved in neurological conditions. This approach could offer a novel mechanism of action compared to existing treatments, which may not specifically target these receptors.678910

What is the purpose of this trial?

This trial is testing the Neurolyser XR, a device that uses strong sound waves to treat chronic low back pain in adults. It targets painful spine joints without surgery. The study aims to see if this method is safe and effective.

Eligibility Criteria

Inclusion Criteria

Patients presenting with a) a positive (>70% pain relief) to a previous, single or double, L1 to L5 lumbar medial branch block (within the last 12 months) and / or b) with a positive (>70% pain relief lasting more than 6 months) to a previous lumbar facet thermal radiofrequency denervation.
You have been experiencing pain in your low back for more than 6 months on either one or both sides.
Your back pain is relieved when you lie down or sit in a comfortable position.
See 3 more

Exclusion Criteria

You are pregnant or currently breastfeeding.
Patients with known osteoporosis with absolute risk of spinal fracture of >10% over 10 years will be excluded
Patients known for concomitant psychiatric disorders, excluding mood disorders.
See 17 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Thermal ablation of the medial nerve branch using High Intensity Focused Ultrasound

Procedure day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
Visits at baseline, 2 days, 1, 2 & 4 weeks, 3 & 6 months

Treatment Details

Interventions

  • Neurolyser XR
Participant Groups
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Thermal ablation of the medial nerve branch using High Intensity Focused Ultrasound

Find a Clinic Near You

Who Is Running the Clinical Trial?

FUSMobile Inc.

Lead Sponsor

Trials
7
Recruited
170+

Findings from Research

A study analyzing 3,940 cases from the FDA Adverse Event Reporting System found that taxane-related neurotoxicity, particularly peripheral neuropathy, is common, especially among elderly patients and females.
The median time for neurological adverse effects to appear after taxane treatment was 27 days, with a significant portion of cases occurring within the first 30 days, and the study reported a fatality rate of 6.13% and hospitalization rate of 28.63% for these adverse events.
Neurotoxicity induced by taxane-derived drugs: analysis of the FAERS database 2017-2021.Zhang, J., Luo, L., Long, E., et al.[2023]
The study presents a curated and standardized version of the FDA Adverse Event Reporting System (FAERS) data, which enhances the quality and usability of drug safety surveillance by removing duplicates and standardizing drug and outcome vocabularies.
This new resource will facilitate faster and more reliable drug safety research by providing pre-computed statistics and reducing the time needed for data management, ultimately improving the identification of adverse drug reactions (ADRs) post-marketing.
A curated and standardized adverse drug event resource to accelerate drug safety research.Banda, JM., Evans, L., Vanguri, RS., et al.[2020]
The study found that there is no formal definition of 'adversity' or guidance on determining the No Observed Adverse Effect Level (NOAEL) in safety pharmacology, indicating a lack of standardized practices in this area.
It was concluded that using NOAEL in safety pharmacology is not recommended, as the diverse functional endpoints measured do not fit into a simple toxic/non-toxic classification, suggesting a need for more nuanced risk assessments in drug development.
Is there a role for the no observed adverse effect level in safety pharmacology?Mow, T., Andersen, NK., Dragsted, N., et al.[2021]

References

Neurotoxicity induced by taxane-derived drugs: analysis of the FAERS database 2017-2021. [2023]
A curated and standardized adverse drug event resource to accelerate drug safety research. [2020]
Is there a role for the no observed adverse effect level in safety pharmacology? [2021]
[Adverse drug events in out-patients as the cause of an initial consultation to neurology]. [2013]
Adverse drug reactions reported by consumers for nervous system medications in Europe 2007 to 2011. [2021]
From Synthetic Fragments of Endogenous Three-Finger Proteins to Potential Drugs. [2020]
Synthesis, Activity, and Application of Fluorescent Analogs of [D1G, Δ14Q]LvIC Targeting α6β4 Nicotinic Acetylcholine Receptor. [2023]
Pharmacotherapeutic implications of the association between genomic instability at chromosome 15q13.3 and autism spectrum disorders. [2013]
An insecticide target in mechanoreceptor neurons. [2023]
Alexa Fluor 546-ArIB[V11L;V16A] is a potent ligand for selectively labeling alpha 7 nicotinic acetylcholine receptors. [2021]
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