Low Back Pain: Clinical Data Show Focused Ultrasound is Safe and Effective


Key Points

  • FUSMobile recently published positive clinical trial results using high-intensity focused ultrasound (HIFU) to treat low back pain. 
  • The Neurolyser XR HIFU system achieved clinical responses comparable with radiofrequency ablation. 

FUSMobile, a high-intensity focused ultrasound (HIFU) company that is treating low back pain under fluoroscopy guidance as an outpatient procedure, recently published positive data from a dual-center, prospective cohort study (NCT04129034) that enrolled 30 participants with lumbar zygapophyseal joint syndrome. 

In “Fluoroscopy-Guided High-Intensity Focused Ultrasound Neurotomy of the Lumbar Zygapophyseal Joints: A Prospective, Open-Label Study,” the company showed that its novel HIFU system, Neurolyser XR, could be used to perform neurotomies that achieved clinical responses comparable with radiofrequency ablation (RFA) – with no significant device- or procedure-related adverse events. The neurotomy procedure was achieved through thermal ablation of the lumbar medial branch nerves. 

The clinical trial enrolled 16 men and 14 women with a mean age of 67.1 years (52, 83) and an average body mass index of 28.4 kg/m2 (19.5, 46). Participants received one to eight (average of 5.6) HIFU sonications at the junction of the transverse process and superior articular process to ablate the medial branch nerve. The entire treatment took from 20 minutes to one hour. Experienced interventional pain physicians performed the procedures in an interventional pain suite under mobile C-arm fluoroscopy guidance. 

To measure treatment effectiveness, investigators analyzed individual responder rate 6 months after the intervention, with success defined as a reduction of two or more points on a pain scale without an increase in opioid intake, or a reduction in opioid intake without an increase in pain. After 6 months, the individual responder rate was 82.6%, with pain severity decreasing from 7.1 at baseline to 3.3. 

“This study strengthens the work of our low back pain pilot study by adding further clinical evidence,” said FUSMobile CEO Arik Hananel, MD. 

Ron Aginsky, FUSMobile’s president, added, “The Neurolyser XR (fluoroscopy-guided system) is designed to provide a superior, noninvasive outpatient method to alleviate low back pain and other conditions. We are also extremely proud of the CE approval for the Neurolyser XR that we received this month.”  

“The history of medicine is often marked by the “latest and greatest” curse,” said the company’s Chief Medical Officer Michael Gofeld. “Fortunately, FUSMobile’s preclinical and clinical research provides a solid foundation, showing that this latest modality for treating facet joint-related pain truly stands out. With regulatory approval, this tool will soon be available and implemented in pain clinics.”

As a side note, FUSMobile’s preclinical dose escalation study was published at the same time as these clinical trial results. It found that the percentage of ablated nerves ranged from 71% to 96% for HIFU (from 1000 to 2000 Joules), whereas RFA achieved a 50% ablation rate. 

See Regional Anesthesia & Pain Medicine (Open Source) 

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