When Epidural Steroid Injections (ESIs) Don’t Provide Lasting Relief
July 20, 2021
When chronic back pain is caused by lumbar spinal stenosis (LSS), all you want is lasting relief so you can get back to your daily life. This was true for Dante Lavino, a patient who was struggling with constant and debilitating LSS pain. Dante’s ability to play golf declined and he even had trouble getting up from his couch. This simple action required him to lean on the coffee table and rest for 15 to 30 seconds before straightening himself up to begin walking. Over time, he was unable to walk without resting.
What are the long-term effects of lumbar spinal stenosis (LSS)?
LSS can cause thickened ligament tissue, excess bone, or bulging discs that can narrow the spinal canal and compress the spinal cord nerves in the lower back. This causes numbness in the lower back, upper legs, or buttocks. For Dante, his long-term pain meant little sleep, and even less activity. And this lasted for years.
Mayo Clinic states that in rare instances, untreated severe spinal stenosis may progress and cause permanent numbness, weakness, balance problems, incontinence, and paralysis. That’s why it’s so important to not just treat the symptoms, but address a major root cause of stenosis.
What are the treatment options for stenosis?
Typically, doctors recommend a course of treatment for lumbar spinal stenosis (LSS) that starts with conservative treatments like over-the-counter pain medication, physical therapy, or chiropractic care. While their safety profile may be strong, these treatments aren’t always effective for everyone. If the pain is still present, doctors may recommend an epidural steroid injection (ESI).
What is an epidural steroid injection (ESI)?
ESIs are commonly administered by pain management doctors to treat lower back pain, including symptomatic lumbar spinal stenosis (LSS). An ESI involves injecting a local anesthetic and a steroid medication directly into the space that surrounds the spinal cord and nerve roots. “While injecting a steroid medication . . . won’t fix the stenosis, it can help reduce the inflammation and relieve some pain,” Mayo Clinic states.
Dante’s initial treatment plan involved ESIs. “We were going to do epidural shots to see if that would relieve my pain and pressure. They gave me the first one and I felt like a new man. It worked great,” Dante said. “Then I had to go back in two weeks to get the second shot. Within a week’s time, that second one and the first one had already worn off. By the time I went back for my third appointment, I was just where I was before I even started the shots.”
According to Mayo Clinic, Dante is not alone in this experience as “steroid injections don’t work for everyone. And repeated steroid injections can weaken nearby bones and connective tissue, so you can only get these injections a few times a year.”
What are some of the reasons why epidural steroid injections (ESIs) don’t work?
Like Dante’s experience, ESIs may not always provide long-term relief for patients with lumbar spinal stenosis (LSS). Repetitive ESIs may provide short-term relief, but do not address a major root cause of stenosis. That’s because anatomical changes are necessary to relieve the pressure of stenosis. It’s helpful to think of stenosis like a kink in a drinking straw. Up to 85% of spinal canal narrowing is caused by the buildup and thickening of ligament that compresses the nerve and ‘kinks’ the straw. To reduce this narrowing and relieve pressure in the central canal (the fluid filled space that runs through the spinal cord), decompression is required. Therefore, repetitive ESIs may just mask the pain in the short term and delay long-term relief.
What are the alternatives to epidural steroid injections (ESIs)?
An alternative to ESIs, or an option to consider if injections are no longer providing relief, is the mild® Procedure. mild® stands for minimally invasive lumbar decompression. It’s a short outpatient procedure that relieves pressure on the spine through an incision smaller than the size of a baby aspirin (5.1 mm). To restore space in the spinal canal and reduce the compression of the nerves—or in the case of the drinking straw, increase the flow—a mild® Doctor uses an imaging machine and specialized tools to remove small pieces of bone and thickened ligament. After looking at a mild® patient brochure, Dante talked to many people about the mild® Procedure, and heard he would be up and walking around in no time as most patients typically resume normal activity within 24 hours with no restrictions. So, he decided to give it a try.
Does the mild® Procedure work?
In fact, for many people, it does. mild® has a safety profile similar to epidural steroid injections (ESIs), but with lasting results. Clinical outcomes for the mild® Procedure include:
Walking / Standing Improvement
In a study performed at the Cleveland Clinic, at one year after the mild® Procedure, patients were able to increase their standing time from eight minutes to 56 minutes with less pain and increase their average walking distance from 246 feet (walking to the mailbox) to 3956 feet (walking around the mall).
Lasting Pain Relief & Increased Mobility
mild® demonstrated excellent long-term durability with significant improvements in both pain and mobility through 2 years. Clinical data from a MiDAS ENCORE 2-Year Study finds mild® provided patients with lasting pain relief and increased mobility.
A five-year study performed at the Cleveland Clinic demonstrated that mild® helped 88% of patients avoid back surgery for at least 5 years, while providing lasting relief.
For Dante, his pain before the procedure was almost at a 10. After the mild® Procedure, he was at a zero. “I had no pain whatsoever,” he said. He is now back on the course, and ready to rejoin (and win) his golf league.
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.
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. We do not discriminate on the basis of sex, age, color, race, religion, marital status, national origin, ancestry, sexual orientation, 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 decompression for lumbar spinal stenosis: the impact of moving to Mild directly or after initial epidural steroid injection (ESI) failure on clinical performance – a six center retrospective report. Abstract presented at: American Society of Pain and Neuroscience Annual Conference; July 22-25, 2021; Miami Beach, FL.