The single-arm clinical trial will assess safety, efficacy, and initial feasibility for the treatment of facet-related low back pain for adult patients diagnosed with chronic lumbar facetogenic pain. Safety will be measured by the incidence and severity of any treatment-related adverse events. Efficacy will be measured by the changes in average pain and disability from baseline to 12 months. Ten patients will be enrolled in the study, which is only open to Canadian residents. The trial will take place in Montreal at McGill University’s Alan Edwards Pain Management Centre and use FUSMobile’s inaugural device, the Neurolyser. Jordi Perez, MD, PhD, FIPP, Associate Professor of Anesthesia, Associate Medical Director of the Alan Edwards Pain Management Unit, and Director of the McGill University Health Centre’s Cancer Pain Program will lead the study.
FUSMobile aims to provide non-invasive, office-based focused ultrasound devices that are highly efficient and cost effective. It was founded by the Focused Ultrasound Foundation’s previous Medical Director, Arik Hananel, MD, MBA, and Ron Aginsky, LLB, MBA, a management executive with 17 years of experience in medical device business development, sales and marketing.