The MOTION study: Two‐year results of a real‐world randomized controlled trial of the mild® procedure for treatment of lumbar spinal stenosis

Abstract

AbstractObjectiveThe MOTION study is designed to measure the impact of percutaneous image‐guided lumbar decompression as a first‐line therapy on patients otherwise receiving real‐world conventional medical management for lumbar spinal stenosis with neurogenic claudication secondary to hypertrophic ligamentum flavum. This prospective, multicenter randomized controlled trial uses objective and patient‐reported outcome measures to compare the combination of the mild® percutaneous treatment and nonsurgical conventional medical management (CMM) to CMM‐Alone.MethodsTest group patients received the mild procedure after study enrollment. Test and control groups were allowed conventional conservative therapies and low‐risk interventional therapies as recommended by their physicians. Subjective outcomes included the Oswestry Disability Index, Numeric Pain Rating Scale, and Zurich Claudication Questionnaire. Objective outcomes included a validated Walking Tolerance Test, the rate of subsequent lumbar spine interventions, and safety data.ResultsTwo‐year follow‐up included 64 mild + CMM and 67 CMM‐Alone patients. All outcome measures showed significant improvement from baseline for mild + CMM, whereas the majority of CMM‐Alone patients had elected to receive mild treatment or other lumbar spine interventions by 2 years, precluding valid 2‐year between‐group comparisons. Neither group reported any device‐ or procedure‐related adverse events.ConclusionsThe durability of mild + CMM for this patient population was demonstrated for all efficacy outcomes through 2 years. Improvements in walking time from baseline to 2 years for patients treated with mild + CMM were significant and substantial. The lack of reported device or procedure‐related adverse events reinforces the strong safety profile of the mild procedure. These results provide support for early interventional treatment of symptomatic LSS with the mild procedure.