MOTION Study: Two-Year Follow-Up of Crossover Patients Treated with the mild® Procedure
Published July 24, 2024
Overview
The MOTION Study, a prospective multicenter randomized controlled study, was designed to evaluate the safety and effectiveness of the mild® Procedure alongside with conventional medical management (CMM) as a first-line therapy in contrast to patients treated with CMM-Alone.
In July 2024, Sherif Costandi, MD, from the Cleveland Clinic shared new MOTION Study data at the American Society of Pain and Neuroscience (ASPN) Annual Conference in Miami, FL. This update compared the 2-year functional outcomes of the CMM-Alone patients who crossed over to mild® with the mild®+CMM as first line treatment group.
Data on subjective and objective measures demonstrate that improvements in patients who received the mild® Procedure after first receiving CMM for up to 1 year are comparable to those in the first-line therapy group (mild®+CMM).
Overview
The MOTION Study, a prospective multicenter randomized controlled study, was designed to evaluate the safety and effectiveness of the mild® Procedure alongside with conventional medical management (CMM) as a first-line therapy in contrast to patients treated with CMM-Alone.
In July 2024, Sherif Costandi, MD, from the Cleveland Clinic shared new MOTION Study data at the American Society of Pain and Neuroscience (ASPN) Annual Conference in Miami, FL. This update compared the 2-year functional outcomes of the CMM-Alone patients who crossed over to mild® with the mild®+CMM as first line treatment group.
Data on subjective and objective measures demonstrate that improvements in patients receiving the mild® Procedure after first receiving CMM up to 1 year are comparable to those in the first-line therapy group (mild®+CMM).
Dr. Costandi Explores “Two-Year Follow-Up of Crossover Patients Treated with the mild® Procedure”
Dr. Costandi Explores “Two-Year Follow-Up of Crossover Patients Treated with the mild® Procedure”
Video Transcript: Dr. Costandi Explores “Two-Year Follow-Up of Crossover Patients Treated with the mild® Procedure”
(00:00) Hello everyone. This is Sherif Costandi. I’m the Pain Medicine Fellowship Director of the Cleveland Clinic. I’m very excited to share with everyone the results of the two years results of the crossover group of MOTION study. Historically, symptomatic spinal stenosis has been treated first with conservative measures that included oral medications, physical therapy, and possible interventions like epidural steroid injections. Those who failed conservative measures were considered for
(00:30) open surgery decompression. With the inception of mild® for the percutaneous image guided lumbar decompression procedure, this algorithm has been challenged and the mild® positioned itself in the middle for those patients who have failed conservative care measures. However, they’re not really candidates for the open surgical decompression or are not willing to proceed for the surgical decompression surgeries. MOTION study is a level one, RCT, multicentric, five year study.
(01:00) The goal of the study was to evaluate mild® as a first line therapy. The design was to randomly assign patients into two cohorts. A group would be receive conservative medical management alone versus another cohort who would receive mild® as a first line therapy, along with conservative medical measures. We had 72 who were enrolled in the mild®,
(01:30) along with CMM versus 76 patients who were enrolled in the CMM alone. After one year, patients were allowed to crossover from the CMM alone and receive the mild®. What we did in this analysis is we looked at the two years outcomes of those patients who crossed over, and then we compared them to the years outcomes of the patients who had mild® with a CMM as a first line therapy. The outcomes that were measured included numeric pain scores.
(02:00) Patient reported measures like as Oswestry Disability Index, Zurich Claudication questionnaire specific to spinal stenosis and walking tolerance test where patients are asked to walk for 15 minutes at their own pace until they either feel hurt or they start to develop some symptoms, they have to stop or they would stop at the 15 minutes. When we looked at the measures, there was no
(02:30) statistical significance between the CMM alone group and the mild®, the patients that received the mild® as a first line therapy. We look at the median improvement of the ODI in the crossover group as 14.3 versus 16.4 in the mild®, along with the CMM. We look at the Zurich Claudication questionnaires. The symptom severity was 0.8 in the crossover versus 0.8 in the mild®, along with the CMM measures. Same thing with the physical function.
(03:00) It was 0.5 versus 0.5 in the mild® and CMM alone. The walking tolerance test was 209% for the crossover versus 222% for the mild® plus the CMM alone. So there was no statistical significance in any of the means improvements in any of the measures that were assessed. Therefore, the patients that had the conservative measures and then received the mild® procedure had similar outcomes to the patients
(03:30) who received the mild® procedure as a first line therapy. With the safety profile of mild® procedure that’s comparable to epidural steroid injections and the plethora of the studies that showed the effectiveness of the mild®, the algorithm of care for symptomatic spinal stenosis is really challenged and we wonder if the mild® could be considered as a first-line therapy. Thank you everyone, and hope you enjoy a great conference. Thank you.
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.
Benyamin RM, Staats PS, MiDAS ENCORE Investigators. mild® is an effective treatment for lumbar spinal stenosis with neurogenic claudication: MiDAS ENCORE Randomized Controlled Trial. Pain Physician. 2016;19(4):229-242.
Mekhail N, Costandi S, Abraham B, Samuel SW. Functional and patient-reported outcomes in symptomatic lumbar spinal stenosis following percutaneous decompression. Pain Pract. 2012;12(6):417-425. doi:10.1111/j.1533-2500.2012.00565.x.
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.
Deer TR, Grider JS, Pope JE, et al. The MIST Guidelines: the Lumbar Spinal Stenosis Consensus Group guidelines for minimally invasive spine treatment. Pain Pract. 2019;19(3)250-274. doi:10.1111/papr.12744.
Hansson T, Suzuki N, Hebelka H, Gaulitz A. The narrowing of the lumbar spinal canal during loaded MRI: the effects of the disc and ligamentum flavum. Eur Spine J. 2009;18(5):679-686. doi:10.1007/s00586-009-0919-7.
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.
Vertos Medical cannot guarantee coding, coverage, or payment for products or procedures. View our Billing Guide.
Vertos is an equal employment opportunity workplace committed to pursuing and hiring a diverse workforce. We strive to grow our team with highly skilled people who share our culture and values. All qualified applicants will receive consideration for employment without regard to sex, age, color, race, religion, marital status, national origin, ancestry, sexual orientation, gender identity, physical & mental disability, medical condition, genetic information, veteran status, or any other basis protected by federal, state or local law.
Hall S, Bartleson JD, Onofrio BM, Baker HL Jr, Okazaki H, O’Duffy JD. Lumbar spinal stenosis. Clinical features, diagnostic procedures, and results of surgical treatment in 68 patients. Ann Intern Med. 1985;103(2):271-275. doi:10.7326/0003-4819-103-2-271.
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.
Fukusaki M, Kobayashi I, Hara T, Sumikawa K. Symptoms of spinal stenosis do not improve after epidural steroid injection. Clin J Pain. 1998;14(2):148-151. doi:10.1097/00002508-199806000-00010.
Mekhail N, Costandi S, Nageeb G, Ekladios C, Saied O. The durability of minimally invasive lumbar decompression procedure in patients with symptomatic lumbar spinal stenosis: Long-term follow-up [published online ahead of print, 2021 May 4]. Pain Pract. 2021;10.1111/papr.13020. doi:10.1111/papr.13020
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.