MOTION Study: mild® at 3-Year Follow-Up in a Multicenter Randomized Controlled Study
Published July 24, 2024
Overview
The MOTION Study is a 5-year prospective, multi-center, randomized controlled study designed to assess the safety and effectiveness of the mild® Procedure alongside with conventional medical management (CMM) as a first-line therapy (treatment group) compared to CMM-Alone (control group).
At the American Society of Pain and Neuroscience (ASPN) Annual Conference in Miami, FL in July 2024, Timothy R. Deer, MD, from The Spine & Nerve Centers of the Virginias shared 3-year follow-up results of the MOTION Study. Data included subjective and objective measures of the group receiving the mild® Procedure (mild® + CMM).
The data provides additional evidence of the durability and safety of mild® as a first-line treatment in a real-world setting, suggesting that while CMM manages symptoms, mild® addresses a primary cause of lumbar spinal stenosis (LSS) by debulking the thickened ligamentum flavum and reducing the compression of neural elements.
Dr. Deer on the Data: “mild® at 3-Year Follow-Up in a Multicenter Randomized Controlled Study”
Video Transcript: Dr. Deer on the Data
(00:00) Hello friends, Tim Deer. The MOTION study is a five-year prospective, randomized controlled trial comparing minimally invasive lumbar decompression where we go in with a small portal and remove pieces of ligament of the ligamentum flavum, that compresses the spinal sac and causes pain with spinal stenosis versus comprehensive medical management, which includes things like physical therapy, injections, medication, ablations, things we normally do in our spine clinic.
(00:30) The 3-year mark we have 40 patients who really are doing quite well. If you look at the data, the outcome measures we’re looking at, things like ODI, things like numeric rating scale, the Zurich claudication scale, and the really, the walking test of how far you can walk, how far you can stand for 15 minutes. All those tests are statistically positive in favor of minimally invasive lumbar decompression. *Statistically positive compared to baseline.
(00:57) In addition, 92% of patients were able to avoid a larger lumbar opened surgery. And I think that’s phenomenal because the other option for these patients have always been open decompression or fusion or both. And I think to see a reduction and large surgery that often are needed, but in this case we found they often aren’t needed and we’re showing that people are doing quite well without bigger interventions.
(01:20) We’ll be presenting this at the ASPN 6th annual meeting. Hope you can join us. If not look for a publication of the three-year data and we’ll be back again, hopefully reporting the four and five-year data to follow. Thank you very much again. Look for the MOTION study. Look for the ligament when you’re treating patients. I’ll see you in Miami.
The views and opinions expressed in this article are those of the authors/speakers and do not necessarily reflect the official policy or position of Vertos Medical. The data is only for the study group receiving the mild® Procedure (mild®+CMM).
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2012 data from Health Market Sciences report for Vertos Medical 2013.
Data on file with Vertos Medical.
Staats PS, Chafin TB, Golvac S, et al. Long-term safety and efficacy of minimally invasive lumbar decompression procedure for the treatment of lumbar spinal stenosis with neurogenic claudication: 2-year results of MiDAS ENCORE. Reg Anesth Pain Med. 2018;43:789-794. doi:10.1097/AAP.0000000000000868.
Based on mild® Procedure data collected in all clinical studies. Major complications are defined as dural tear and blood loss requiring transfusion.
MiDAS ENCORE responder data. On file with Vertos Medical.
Jain S, Deer TR, Sayed D, et al. Minimally invasive lumbar decompression: a review of indications, techniques, efficacy and safety. Pain Manag. 2020;10(5). https://doi.org/10.2217/pmt-2020-0037. Accessed June 1, 2020.
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Treatment options shown are commonly offered once conservative therapies (e.g., physical therapy, pain medications, chiropractic) are not providing adequate relief. This is not intended to be a complete list of all treatments available. Doctors typically recommend treatments based on their safety profile, typically prioritizing low risk/less aggressive procedures before higher risk/more aggressive procedures, but will determine which treatments are appropriate for their patients.
The mild® Procedure is a minimally invasive treatment for lumbar spinal stenosis. As with most surgical procedures, serious adverse events, some of which can be fatal, can occur, including heart attack, cardiac arrest (heart stops beating), stroke, and embolism (blood or fat that migrates to the lungs or heart). Other risks include infection and bleeding, spinal cord and nerve injury that can, in rare instances, cause paralysis. This procedure is not for everyone. Physicians should discuss potential risks with patients. For complete information regarding indications for use, warnings, precautions, and methods of use, please reference the devices’ Instructions for Use.
Patient stories on this website reflect the results experienced by individuals who have undergone the mild® Procedure. Patients are not compensated for their testimonial. The mild® Procedure is intended to treat lumbar spinal stenosis (LSS) caused by ligamentum flavum hypertrophy. Although patients may experience relief from the procedure, individual results may vary. Individuals may have symptoms persist or evolve or other conditions that require ongoing medication or additional treatments. Please consult with your doctor to determine if this procedure is right for you.
Reimbursement, especially coding, is dynamic and changes every year. Laws and regulations involving reimbursement are also complex and change frequently. Providers are responsible for determining medical necessity and reporting the codes that accurately describe the work that is done and the products and procedures that are furnished to patients. For this reason, Vertos Medical strongly recommends that you consult with your payers, your specialty society, or the AMA CPT regarding coding, coverage and payment.
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Kalichman L, Cole R, Kim DH, et al. Spinal stenosis prevalence & association with symptoms: The Framingham Study. Spine J. 2009;9(7):545-550. doi:10.1016/j.spinee.2009.03.005.
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Friedly JL, Comstock BA, Turner JA, et al. Long-Term Effects of Repeated Injections of Local Anesthetic With or Without Corticosteroid for Lumbar Spinal Stenosis: A Randomized Trial. Arch Phys Med Rehabil. 2017;98(8):1499-1507.e2. doi:10.1016/j.apmr.2017.02.029
Pope J, Deer TR, Falowski SM. A retrospective, single-center, quantitative analysis of adverse events in patients undergoing spinal stenosis with neurogenic claudication using a novel percutaneous direct lumbar decompression strategy. J Pain Res. 2021;14:1909-1913. doi: 10.2147/JPR.S304997
Pryzbylkowski P, Bux A, Chandwani K, et al. Minimally invasive direct decompression for lumbar spinal stenosis: impact of multiple prior epidural steroid injections [published online ahead of print, 2021 Aug 4]. Pain Manag. 2021;10.2217/pmt-2021-0056. doi:10.2217/pmt-2021-0056
Abstract presented at: American Society of Pain and Neuroscience Annual Conference; July 22-25, 2021; Miami Beach, FL.
Mobility Matters: Low Back Pain in America, Harris Poll Survey, 2022. View data and full summary here.
Deer TR, Grider JS, Pope JE, et al. Best Practices for Minimally Invasive Lumbar Spinal Stenosis Treatment 2.0 (MIST): Consensus Guidance from the American Society of Pain and Neuroscience (ASPN). J Pain Res. 2022;15:1325-1354. Published 2022 May 5. doi:10.2147/JPR.S355285.