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Home/Spine/Spine Pain Study Reaches Full Enrollment
Spine

Spine Pain Study Reaches Full Enrollment

April 24, 2015 1 min read Premium comments

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Spine Pain Study Reaches Full Enrollment
Spinal Injections / Courtesy: Vertos Medical
Secondary

A national 27-site study comparing minimally invasive lumbar decompression (MILD) with epidural steroid injections (ESIs) has reached full enrollment and all patients have been treated, according to a report in PRWeb.

The randomized controlled study, named MiDAS ENCORE, will examine the long-term benefits for approximately 300 patients who received either minimally invasive lumbar decompression (MILD) or epidural steroid injections (ESIs).

Chronic back pain is the most common health problem in the United States, affecting hundreds of thousands every year. Most are in the Medicare population. As explained by PRWeb, lumbar spinal stenosis is primarily a degenerative, age-related narrowing of the lower spinal canal resulting in compression of the nerve roots. MILD treats this compression by removing small portions of lamina and hypertrophic ligametum flavum in a minimally invasive, outpatient procedure through an opening about the size of a baby aspirin.

“There have been more than 20, 000 patients treated with MILD and given the low cost of the procedure, this therapy could provide significant benefits to the health care system, ” said Peter Staats, M.D., a study principal investigator and secretary of the American Society of Interventional Pain Physicians, The study is part of the Coverage with Evidence Development (CED) status granted by the Centers for Medicare & Medicaid Services (CMS) in January 2014.

PRWeb quoted Staats, as saying, “We hope the data from this study will show that the treatment is safe and effective and can be offered to the many patients who currently lack viable treatment options for their lumbar stenosis symptoms.”

MILD is a product of Vertos Medical, of Aliso Viejo, California, a company that claims to be committed to developing innovative, minimally invasive treatments for lumbar spinal stenosis.

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Discussion

14
DS
Dr. Sarah MitchellOrthopedic Surgeon · Mayo Clinic

This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?

8
JT
James Thornton, MDSpine Fellow · HSS

Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.

5
RP
R. PatelSports Medicine · Stanford

We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.

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