title: MiDAS ENCORE: Randomized Controlled Clinical Trial Report of 6-Month Results.
abstract: BACKGROUND
  Patients suffering from neurogenic claudication due to lumbar spinal stenosis (LSS) often experience moderate to severe pain and significant functional disability. Neurogenic claudication results from progressive degenerative changes in the spine, and most often affects the elderly. Both the MILD® procedure and epidural steroid injections (ESIs) offer interventional pain treatment options for LSS patients experiencing neurogenic claudication refractory to more conservative therapies. MILD provides an alternative to ESIs via minimally invasive lumbar decompression.
  
  
  METHODS
  Prospective, multi-center, randomized controlled clinical trial.
  
  
  METHODS
  Twenty-six US interventional pain management centers.
  
  
  OBJECTIVE
  To compare patient outcomes following treatment with either MILD (treatment group) or ESIs (active control group) in LSS patients with neurogenic claudication and verified ligamentum flavum hypertrophy.
  
  
  METHODS
  This prospective, multi-center, randomized controlled clinical trial includes 2 study arms with a 1-to-1 randomization ratio. A total of 302 patients were enrolled, with 149 randomized to MILD and 153 to the active control. Six-month follow-up has been completed and is presented in this report. In addition, one year follow-up will be conducted for patients in both study arms, and supplementary 2 year outcome data will be collected for patients in the MILD group only.
  
  
  METHODS
  Outcomes are assessed using the Oswestry Disability Index (ODI), numeric pain rating scale (NPRS) and Zurich Claudication Questionnaire (ZCQ). Primary efficacy is the proportion of ODI responders, tested for statistical superiority of the MILD group versus the active control group. ODI responders are defined as patients achieving the validated Minimal Important Change (MIC) of =10 point improvement in ODI from baseline to follow-up. Similarly, secondary efficacy includes proportion of NPRS and ZCQ responders using validated MIC thresholds. Primary safety is the incidence of device or procedure-related adverse events in each group.
  
  
  RESULTS
  At 6 months, all primary and secondary efficacy results provided statistically significant evidence that MILD is superior to the active control. For primary efficacy, the proportion of ODI responders in the MILD group (62.2%) was statistically significantly higher than for the epidural steroid group (35.7%) (P < 0.001). Further, all secondary efficacy parameters demonstrated statistical superiority of MILD versus the active control. The primary safety endpoint was achieved, demonstrating that there is no difference in safety between MILD and ESIs (P = 1.00).
  
  
  CONCLUSIONS
  Limitations include lack of patient blinding due to considerable differences in treatment protocols, and a potentially higher non-responder rate for both groups versus standard-of-care due to study restrictions on adjunctive pain therapies.
  
  
  CONCLUSIONS
  Six month follow-up data from this trial demonstrate that the MILD procedure is statistically superior to epidural steroids, a known active treatment for LSS patients with neurogenic claudication and verified central stenosis due to ligamentum flavum hypertrophy. The results of all primary and secondary efficacy outcome measures achieved statistically superior outcomes in the MILD group versus ESIs. Further, there were no statistically significant differences in the safety profile between study groups. This prospective, multi-center, randomized controlled clinical trial provides strong evidence of the effectiveness of MILD versus epidural steroids in this patient population.
  
  
  BACKGROUND
  NCT02093520.
authors.affiliation: Premier Pain Centers, Shrewsbury, NJ and Johns Hopkins University School of Medicine, Baltimore, MD.
authors.forename: Peter S
authors.initials: PS
authors.lastname: Staats
authors.forename: Ramsin M
authors.initials: RM
authors.lastname: Benyamin
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D015360:Analgesia, Epidural / Q000379:methods* / Q000639:trends; D019299:Decompression, Surgical / Q000379:methods* / Q000639:trends; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008159:Lumbar Vertebrae; D008297:Male; D008875:Middle Aged; D019060:Minimally Invasive Surgical Procedures / Q000379:methods* / Q000639:trends; D010146:Pain / Q000175:diagnosis / Q000209:etiology; D059408:Pain Management / Q000379:methods* / Q000639:trends; D010147:Pain Measurement / Q000379:methods / Q000639:trends; D011446:Prospective Studies; D013130:Spinal Stenosis / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D013256:Steroids / Q000008:administration & dosage*; D011795:Surveys and Questionnaires
chemical_list: D013256:Steroids