Objective real-world outcomes of patients suffering from painful neurogenic claudication treated with the mild® procedure: Interim 6month report of a randomized controlled trial

Background: Lumbar spinal stenosis (LSS) is a serious degenerative condition of the spine that can cause significant functional disability. Therapies for these patients generally begin with conservative management, since more invasive interventions such as open surgery and spinal implants are associated with higher complication rates. Early in the treatment algorithm for LSS patients, multiple conventional medical management (CMM) therapies are often combined as an initial low-risk treatment strategy. This composite first-line treatment plan may include conservative care together with early interventional treatment options such as epidural steroid injections, radiofrequency ablation and the mild® Procedure. Methods: This prospective randomized controlled trial evaluates patients aged 50 to 80 years treated with mild plus CMM, compared to those treated with CMM alone, as the active control. Walking tolerance test outcomes and incidence of subsequent disallowed procedures provided objective real-world outcome data. The incidence of device or procedure-related adverse events was analyzed. Follow-up includes 6-month, 1-year and 2-year assessments, with 1-year being primary. Patients in the mild+CMM group are followed at 3, 4, and 5 years. This is a report of interim 6-month outcomes. Results: Of 155 patients enrolled at 19 US interventional pain management centers, 78 were allocated to CMM-Alone, and 77 to mild+CMM. At 6-months, the validated walking tolerance test demonstrated statistical superiority of mild+CMM versus CMM-Alone (p<0.001). The incidence of patients receiving a subsequent disallowed procedure, and thereby considered treatment failures in their study group, was statistically significantly higher in CMM-Alone versus mild+CMM (p<0.001). There were no device or procedurerelated adverse events in either group. Conclusion: At 6-months, the mild Procedure combined with CMM provided statistically superior objective real-world outcomes versus CMM-Alone. There were no device or procedure-related adverse events reported in either study group. With its excellent safety profile and superior efficacy, mild is uniquely positioned as early first-line therapy.