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 12 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
10
Thermal ablation of the medial nerve branch using High Intensity Focused Ultrasound
Rambam
Haifa, Israel
Numerical rating scale of pain (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 & 12 months after procedure
Saftey
Procedure and Device Safety at six months as measured by measured by the number 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 & 12 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 & 12 months after procedure
Patient Global Impression of Change (PGIC)
Patient Global Impression of Change (Range: 1 to 7)
Time frame: Time Frame: 1, & 4 weeks, 3, 6 & 12 months after procedure
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