Evidence map›Paper›PMID 30199512›Full record

Trial reportRegional anesthesia and pain medicine2018

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.

Peter S Staats, Timothy B Chafin, Stanley Golovac, Christopher K Kim, Sean Li, William B Richardson, Ricardo Vallejo, Sayed E Wahezi, Edward P Washabaugh, Ramsin M Benyamin and 1 more

Registry-linked trialOpen access · hybridAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Regional anesthesia and pain medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02093520 (MILD® Percutaneous Image-Guided Lumbar Decompression Versus Epidural Steroid Injections in Patients With Lumbar Spinal Stenosis Exhibiting Neurogenic Claudication), which is not on this map. Cited by 28 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 1 pooled it
2.5field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02093520 nacompletednot on this map

MILD® Percutaneous Image-Guided Lumbar Decompression Versus Epidural Steroid Injections in Patients With Lumbar Spinal Stenosis Exhibiting Neurogenic Claudication

TypeinterventionalSponsorVertos Medical, Inc.Ran2014 to 2017Enrolled302ConditionsSpinal Stenosis, Lumbar Region, With Neurogenic ClaudicationArmsMILD Procedure, Epidural Steroid Injection
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 1 synthesis or guideline pooled it, 35 citations in OpenAlex.

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  7. Disc bulging predicts poor outcomes of decompression surgery for lumbar spinal canal stenosis.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 7 institutions in 1 country.

Peter S Staats
Timothy B ChafinDepartment of Pain Management and Rehabilitation Medicine, Vidant Roanoke-Chowan Hospital, Ahoskie, NC.
Stanley GolovacFlorida Pain Institute, Merritt Island, FL.
Christopher K KimThe Center for Pain Relief, Charleston, WV.
Sean LiPremier Pain Centers, Shrewsbury, NJ.
William B RichardsonSoutheastern Spine Institute, Mount Pleasant, SC.
Ricardo VallejoMillennium Pain Center, Bloomington, IL.
Sayed E WaheziDepartments of Physical Medicine and Rehabilitation and Anesthesiology, Albert Einstein College of Medicine at Montefiore, Montefiore Medical Center, Bronx, NY.
Edward P WashabaughMichigan Pain Specialists, Ypsilanti, MI.
Ramsin M BenyaminMillennium Pain Center, Bloomington, IL.
MiDAS ENCORE Investigators
Millennium Pain Center · USAlbert Einstein College of Medicine · USFlorida Pain Institute · USMedical Advanced Pain Specialists · USPain Management Centers Of America · USRoanoke-Chowan Community College · USSoutheastern Spine Center & Research Institute · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesThis study evaluated the long-term durability of the minimally invasive lumbar decompression (MILD) procedure in terms of functional improvement and pain reduction for patients with lumbar spinal stenosis and neurogenic claudication due to hypertrophic ligamentum flavum. This is a report of 2-year follow-up for MILD study patients.

methodsThis prospective, multicenter, randomized controlled clinical study compared outcomes for 143 patients treated with MILD versus 131 treated with epidural steroid injections. Follow-up occurred at 6 months and at 1 year for the randomized phase and at 2 years for MILD subjects only. Oswestry Disability Index, Numeric Pain Rating Scale, and Zurich Claudication Questionnaire were used to evaluate function and pain. Safety was evaluated by assessing incidence of device-/procedure-related adverse events.

resultsAll outcome measures demonstrated clinically meaningful and statistically significant improvement from baseline through 6-month, 1-year, and 2-year follow-ups. At 2 years, Oswestry Disability Index improved by 22.7 points, Numeric Pain Rating Scale improved by 3.6 points, and Zurich Claudication Questionnaire symptom severity and physical function domains improved by 1.0 and 0.8 points, respectively. There were no serious device-/procedure-related adverse events, and 1.3% experienced a device-/procedure-related adverse event.

conclusionsMILD showed excellent long-term durability, and there was no evidence of spinal instability through 2-year follow-up. Reoperation and spinal fracture rates are lower, and safety is higher for MILD versus other lumbar spine interventions, including interspinous spacers, surgical decompression, and spinal fusion. Given the minimally invasive nature of this procedure, its robust success rate, and durability of outcomes, MILD is an excellent choice for first-line therapy for select patients with central spinal stenosis suffering from neurogenic claudication symptoms with hypertrophic ligamentum flavum. CLINICAL

trial registrationThis study was registered at ClinicalTrials.gov, identifier NCT02093520.

Indexed as

AgedAged, 80 and overDecompression, SurgicalFemaleFollow-Up StudiesHumansLigamentum FlavumLumbar VertebraeMaleMinimally Invasive Surgical ProceduresSpinal StenosisTime FactorsTreatment Outcome

Identifiers

PMID30199512
PMCPMC6319572
OpenAlexW2890081318

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.