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
Overview
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
Conclusions
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.
Video
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:
(00:00):
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.
(00:53):
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.
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.
Although the complication rate for the mild® Procedure is low, 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.
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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.