Case Study: Leading Physician Helps Male Patient (71) Reduce Pain and Improve Quality of Life with mild®
April 15, 2021
mild® Provider, Dr. Mark Coleman | ABA Certified Pain Medicine Specialist | National Spine & Pain Centers
This case study highlights a male patient, age 71, with severe back pain that prevented him from performing his duties as a bus driver, as well as taking trips to the market with his sister. He underwent failed interventions, including multiple epidural steroid injections (ESIs), and finally found relief with Dr. Coleman, a leading pain management specialist and President of Clinical Operations at National Spine & Pain Centers, when he performed the mild® Procedure using the Streamlined Technique with a single midline incision.
Patient History: Pre-mild®
The patient had moderate, chronic constipation but was otherwise healthy. His history showed symptomatic lumbar spinal stenosis for three years. Symptoms grew more severe in the six months leading up to mild®. The patient failed four lifetime lumbar epidural steroid injections (LESIs) with other providers (two within the three months prior to mild®). He had no previous surgical history.
Symptoms of Neurogenic Claudication
The patient presented with classic symptoms of neurogenic claudication, including back and buttock pain with an inability to stand for more than two or three minutes. He experienced limited mobility, with a walking tolerance of two minutes with a cane. His pain increased with ambulation and produced numbness and tingling going down into the hamstrings. The pain was so severe, the patient had been unable to work as a bus driver in the previous six months.
The patient set goals of:
Returning to work
Performing activities of daily living (e.g., grocery shopping)
An MRI was performed, which found multiple levels of stenosis and several spinal comorbidities.
Hypertrophic ligamentum flavum resulting in severe [lumbar] spinal central stenosis
Facet hypertrophy with right foraminal extrusion of the disc leading to moderate to severe right foraminal stenosis
Hypertrophic ligamentum flavum with moderate stenosis and degenerative facet arthropathy
Degenerative facet hypertrophy with hypertrophic ligamentum flavum resulting in moderate lumbar spinal stenosis
Bilateral lateral foraminal stenosis
Dr. Coleman treated three levels bilaterally using the Streamlined Technique, an efficient and predictable procedural method utilizing a single midline incision. Dr. Coleman used MAC sedation with a local anesthetic at an outpatient treatment center.
Upon discharge, the patient was instructed to resume normal activity within 24 hours with no restrictions.
After one week, the patient was able to walk for more than 20 minutes, up from less than three minutes before mild®. The patient’s VAS went from 5/10 to 0/10 and he reported 100% pain relief. One day post procedure he was able to stand and ambulate without much pain.
“I haven’t had any problems since.” “I took my sister to the market, I haven’t been able to do that!”
Watch the patient tell his results in his own words.
Video courtesy of National Spine & Pain Centers.
“The patient had multiple spinal comorbidities contributing to his moderate/severe stenosis including facet hypertrophy, foraminal stenosis and hypertrophic ligamentum flavum. I was able to treat the HLF (hypertrophic ligamentum flavum) bilaterally through a single midline incision with efficient access to all three stenosed levels. Decompression of just the HLF provided significant relief for the patient–resulting both in pain and functional improvement.”
“This patient is a perfect example of how imperative it is to move on from ESIs when they are no longer effective. … With the equivalent safety profile of an ESI, mild® is the logical next step.”
The views and opinions expressed in this article are those of the author and do not necessarily reflect the official policy or position of Vertos Medical. This material is provided for guidance and/or illustrative purposes only and should not be construed as a guarantee of future results or a substitution for legal advice and/or medical advice from a healthcare provider. This material is provided for general educational purposes only and should not be considered the exclusive source for this type of information. Vertos Medical does not practice medicine and assumes no responsibility for the administration of patient care. At all times, it is the professional responsibility of the practice or clinical practitioner to exercise independent judgment. Results may vary.
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.
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.
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.