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
Study design: Prospective, single arm Timeline: six month enrollment period and 6 months follow-up period. Sites: The study will be conducted at five sites in Canada: McGill University, Toronto Western, Silver Medical Group, Precision Sport \& Spine, Kinetix Integrated Orthopaedic \& Regenerative Medicine Study population: Thirty adult patients diagnosed with facet related low back pain. Primary study objective: Safety and efficacy of the Neurolyser XR for the treatment of chronic low back pain secondary to zygapophyseal joint syndrome. Safety is measured by the incidence and severity of treatment related adverse events. Efficacy is measured by the changes in pain severity at the treatment area, using a numerical rating scale (NRS), of 0 to 10 between baseline and 6 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Non-Invasive Thermal Ablation of the Medial Branch Nerves
Kinetix Medicine
Vancouver, British Columbia, Canada
Precision Sport & Spine
Oakville, Ontario, Canada
Silver Medical Group
Toronto, Ontario, Canada
Toronto Western
Toronto, Ontario, Canada
NRS
Change in average pain score as measured by a numeric rating scale from 0 (no pain) to 10, worst possible pain
Time frame: Time Frame: Base line, 2 days 1, 2 & 4 weeks, 3 & 6 months after procedure
Procedure and Device Safety at six months as measured by measured by the incidence and severity of treatment related adverse events
Safety will be measured by the incidence and severity of treatment related adverse events
Time frame: Time Frame: 6 months after procedure
Lesion Size
Lesion size and location as shown in MRI Image, 2 days post treatment.
Time frame: 2 days post procedure
Oswestry Disability Index (ODI)
Low Back Pain Questionnaire (Range: 0% to 100%)
Time frame: Time Frame: Base line, 1, & 4 weeks, 3 & 6 months after procedure
Short Form 12 (SF-12)
A multipurpose short form survey with 12 questions (Range: 0 to 100)
Time frame: Time Frame: Base line, 1, & 4 weeks, 3 & 6 months after procedure
Patient Global Impression of Change (PGIC)
Patient Global Impression of Change (Range: 1 to 7)
Time frame: Time Frame: Base line, 1, & 4 weeks, 3 & 6 months after procedure
Procedure and Device Safety as measured by measured by the incidence and severity of treatment related adverse events
Safety will be measured by the incidence and severity of treatment related adverse events
Time frame: Time Frame: Base line, Procedure day, 2 days 1, 2 & 4 weeks, 3 & 6 months after procedure
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Alan Edwards Pain Management Unit - Montreal General Hospital
Montreal, Quebec, Canada