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 range55 Years – 85 Years
SexALL
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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).
✕. Patients with history of lumbosacral spine surgery excluding previous lumbar radiofrequency neurotomy
✕. Patients who have had lumbar radiofrequency neurotomy in the past 6 months
✕
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 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.