Vertos Medical Clinical Publication

The MOTION Study: A Randomized Controlled Trial with Objective Real-World Outcomes for Lumbar Spinal Stenosis Patients Treated with the mild® Procedure 1-Year Results

Source— Pain Medicine Author— Timothy R Deer, Shrif J Costandi, Edward Washabaugh, Timothy B Chafin, Sayed E Wahezi, Navdeep Jassal, Dawood Sayed Published February 15, 2022

The purpose of this study was to provide Level-1 objective, real-world outcome data for patients with lumbar spinal stenosis (LSS) suffering from neurogenic claudication secondary to hypertrophic ligamentum flavum (HLF). In the study, patients were treated with mild® plus conventional medical management (CMM) or CMM alone, reflecting real-world treatment progression and patient care.

Both the mild®+CMM and the control group were allowed unrestricted access to conventional real-world therapies. Patient reported outcomes included Oswestry Disability Index (ODI), Zurich Claudication Questionnaire (ZCQ), and Numeric Pain Rating Scale (NPRS). A validated Walking Tolerance Test, incidence of subsequent lumbar spine interventions, and occurrence of adverse events were used to measure objective outcomes.

Sixty-nine patients in each group were analyzed at 1-year follow-up. No device or procedure-related adverse events were reported in either group. The 1-year results of the Level-1 MOTION randomized controlled trial demonstrate the superiority of the mild® Procedure in combination with CMM over the use of CMM alone for LSS patients suffering from neurogenic claudication secondary to HLF.

Additional 1-year data for patients receiving the mild® Procedure plus CMM vs CMM alone include:

Hear interventional pain specialist and national principal investigator for the MOTION Study, Dr. Timothy Deer, discuss why mild® is a safe, durable, minimally invasive procedure that has been shown to be effective as an early interventional therapy for patients suffering from symptomatic LSS.

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