Vertos Medical Clinical Publication

The MOTION Study: Two-Year Results of a Real-World Randomized Controlled Trial of the mild® Procedure for Treatment of Lumbar Spinal Stenosis

Source— PAIN Practice Author— Timothy R. Deer MD, Timothy B. Chafin MD, Shrif J. Costandi MD, Huaguang Qu MD, Christopher Kim MD, Navdeep Jassal MD, Kiran Patel MD, Aaron Calodney MD Published September 3, 2023


The MOTION Study is designed to measure the impact of percutaneous image-guided lumbar decompression (PILD) as a first-line therapy on patients otherwise receiving real-world conventional medical management for lumbar spinal stenosis (LSS) with neurogenic claudication (NC) secondary to hypertrophic ligamentum flavum.

This Level-1 prospective, multi-center randomized controlled trial uses objective and patient-reported outcome measures to compare the combination of the mild® percutaneous treatment and non-surgical conventional medical management (CMM) to CMM-Alone.

CMM was defined as any conservative or low-risk interventional therapies that are options for early treatment of NC. These options include physical therapy, home exercise, walking aids, early interventional therapies such as epidural steroid injections, lumbar facet medial branch nerve blocks, facet joint injections, and radiofrequency ablation.

2-year Results

Two-year follow-up of the MOTION Study 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.

The 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.

Additional 2-year data for patients receiving the mild® Procedure plus CMM include:

  • 14.6 point mean change ODI improvement from baseline
  • 197% improvement in walking time from baseline
  • 0% device- or procedure-related adverse or serious adverse events
  • Over 77% of CMM-Alone patients had undergone a subsequent lumbar spine intervention which was over a 7 times higher rate than the mild®+CMM


Together with subjective patient-reported outcomes, this study demonstrated that the mild® Procedure, when combined with CMM, is superior in providing improved function and decreased pain when compared to CMM-Alone for these patients. CMM can provide some relief for patients only by managing symptoms, while the mild® Procedure instead addresses a primary cause of LSS by debulking the thickened ligamentum flavum and reducing the compression of nerve tissue. 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.


Hear from Dr. Timothy Deer, principal investigator for the MOTION Study and Chairman of the American Society of Pain & Neuroscience, as he discusses the 2-year results and why mild® is an effective, early interventional treatment for patients suffering from symptomatic LSS.

Transcript of Dr. Deer’s video:

Hello, I’m Tim Deer. I want to talk to you today about the MOTION Study, a Level-1 study where we have 19 centers in the United States doing real world experiences with a minimally invasive lumbar decompression procedure, mild®. In that study, we have mild® versus medical management, and again, we look at how they do over one and now 24 months. And this is about that publication. You may remember 12 months ago I talked to you about the results of the 12-month publication, and I’m happy to report that the results remain enduring. And what I mean by that, the ODI remains markedly significant. The walking tolerance, which I think is a real measure of lumbar degenerative stenosis treatment, remains excellent. Pain scores remain excellent. All those remain markedly, statistically significantly better in the mild® group. Even more impressively, very few of those patients needed additional surgery for the same condition.

So we really minimized the need for larger, more risky, more expensive procedures, and I think that’s going to be the future of medicine – less invasive, safer for the patient, with really minimal hospitalization stays. The main goal is to continue improving function. The 2-year, 24-month data shows function as markedly better and remains that way. Two years after the procedure, there’s endurance and it’s also in a group of people that really represents the real world. I think what it also shows is medical management alone for stenosis patients, who is trying to avoid a major surgery, doesn’t work very well long term. And I think that’s important to note when we think we’re doing better than we are with our medical management. So, to conclude, real world Level-1 data multicenter, reproducible now, compared to previous studies we’ve done, shows that the therapy of minimally invasive lumbar decompression when the ligamentum flavum is more than 2.5 millimeters causing stenosis, is enduring and has great outcomes. Hope you click on the article below and share the article with your friends. Have a great day.

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