Understanding Whether Chronic Lower Back Pain Patients with Lumbar Spinal Stenosis Benefit From Multiple Epidural Steroid Injections Prior to the mild® Procedure
Source— Pain ManagementAuthor— Pryzbylkowski P, Bux A, Chandwani K, et al.
November 9, 2021
Originally published in Pain Management, this article is a summary of a study performed to look at the benefit, if any, of more than one epidural steroid injection (ESI) in the spine before the mild® Procedure. Minimally invasive lumbar decompression (commonly known as the mild® Procedure) and ESIs are both common treatment options for lumbar spinal stenosis (LSS), a condition that causes chronic lower back pain in older adults.
To determine how to best treat LSS patients, healthcare professionals use a guide to help with the decision-making process (called an algorithm) to pass through non-medical to more invasive therapies that often includes one or more ESIs. An ESI is medication inserted in the lower back to reduce swelling and provide relief from pain. Researchers wanted to look at a change to when in the treatment process the mild® Procedure is carried out.
In the study, researchers compared the medical records of participants who had received either just one or no steroid injection prior to the mild® Procedure, to participants who received two or more epidural steroid injections prior to the mild® Procedure. Similar outcomes in both treatment groups in this study proved that giving more than one ESI prior to mild® did not improve how well patients did and may have delayed patient care.
Based on the results of the study, it is recommended that the standard treatment process for LSS patients be changed to give the mild® Procedure either, as soon as LSS is diagnosed or after the failure of the first ESI.
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.
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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.
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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.
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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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
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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 at knowyourbackstory.com.