Safety and Initial Feasibility of Using the Neurolyser XR Device for the Treatment of Axial Chron… (NCT04129034) | Clinical Trial Compass
UnknownNot Applicable
Safety and Initial Feasibility of Using the Neurolyser XR Device for the Treatment of Axial Chronic Low Back Pain
Canada30 participantsStarted 2019-09-24
Plain-language summary
Single arm pilot study to evaluate the safety and initial feasibility of the Neurolyser XR, a high intensity focused ultrasound device, for non-invasive treatment of axial chronic low back pain
Who can participate
Age range
55 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adult male and females \>55 years of age 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 low back pain of \> 6 months duration
. Patients whose back pain is alleviated by recumbency or comfortable sitting position
. 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.
. Average pain score of 6 or higher in the last month, (on 0-10 scale).
Exclusion criteria
. Pregnant or breastfeeding patient
. Patients younger than 55 or older than 85 years
. Patients presenting with neurological deficits (including lumbosacral radiculopathy but not solitary radicular pain).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
NRS
Timeframe: Time Frame: Base line, 2 days 1, 2 & 4 weeks, 3 & 6 months after procedure
2
Procedure and Device Safety at six months as measured by measured by the incidence and severity of treatment related adverse events
. Patients with history of lumbosacral spine surgery excluding previous lumbar radiofrequency neurotomy
. Patients who have had lumbar radiofrequency neurotomy in the past 6 months
. Patients with the presence of metal hardware or other foreign objects at the lumbosacral spine
. Patients with history of lumbar spine pathology that may increase procedural risk and / or influence symptoms and / or generate unrelated adverse event, (per the discretion of the study PI)
. Patients unable to understand and complete the research questionnaires in the official language used within the particular sites' location.