Double arm pivotal study to evaluate the Neurolyser XR as a non-invasive treatment of axial chronic low back pain
Study design: Prospective, Double Arm Timeline: Twelve months enrollment period and 6 months follow-up period. Sites: The study will be conducted at 10 sites in the USA Study population: 80 adult subjects diagnosed with facet related low back pain with an additional 10 roll in subjects. Arms: 40 patients would be treated by the NeurolyserXR and 40 would get a sham treatment Crossover: blinded crossover between the two arms could be done between 1 and 3 months 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 pain numerical rating scale
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
Thermal ablation of the medial nerve branch using High Intensity Focused Ultrasound
Sham procedure done in an identical manner to the treatment arm, but without deploying acoustical energy
Stamford Hospital
Stamford, Connecticut, United States
Mayo University Jacksonville
Jacksonville, Florida, United States
Univ of Miami Rehabilitation Medicine
Miami, Florida, United States
NRS
Change in average pain score as measured by a numeric rating scale from 0 (no pain) to 10, worst possible pain
Time frame: Base line, 2 days 1, 2 & 4 weeks, 3 & 6 months after procedure
Procedure and Device Safety up to six months post procedure
Safety will be measured by the incidence and severity of treatment related adverse events
Time frame: 6 months after 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
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
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Emory
Atlanta, Georgia, United States
The Physicians Spine and Rehabilitation Specialist of GA
Atlanta, Georgia, United States
Charlie Norwood VA Medical Center
Augusta, Georgia, United States
Ainsworth Institute of Pain Management
New York, New York, United States
Center for Clinical Research
Winston-Salem, North Carolina, United States
University of Virginia Pain Management Center
Charlottesville, Virginia, United States
Gershon Pain Specialists
Virginia Beach, Virginia, United States