Evidence map›Paper›PMID 31481010›Full record

ArticleBMC neurology2019

Transforaminal epidural injection versus continued conservative care in acute sciatica (TEIAS trial): study protocol for a randomized controlled trial.

Eduard Verheijen, Alexander G Munts, Oscar van Haagen, Dirk de Vries, Olaf Dekkers, Wilbert van den Hout, Carmen Vleggeert-Lankamp

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC neurology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03924791 (Transforaminal Epidural Injection in Acute Sciatica), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.6field-weighted citation impact, top 31% 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.

NCT03924791 naunknown statusnot on this map

Transforaminal Epidural Injection in Acute Sciatica

TypeinterventionalSponsorC.L.A.Vleggeert-LankampRan2019 to 2026Enrolled142ConditionsSciatica, Sciatica Due to Intervertebral Disc Disorder, Sciatic RadiculopathyArmsLidocaine, Methylprednisolone Acetate, Dexamethasone
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 8 citations in OpenAlex.

  1. Trial
  2. Article
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

7 authors at 2 institutions in 1 country.

Eduard VerheijenDepartment of Neurosurgery, Leiden University Medical Center, Albinusdreef 2, PO Box 9600. 2300, RC, Leiden, The Netherlands. e.j.a.verheijen@lumc.nl.ORCID http://orcid.org/0000-0001-9202-4496
Alexander G MuntsDepartment of Neurology, Spaarne Gasthuis, Haarlem, /Hoofddorp, The Netherlands.
Oscar van HaagenDepartment of Anaesthesiology, Spaarne Gasthuis, Haarlem, /Hoofddorp, The Netherlands.
Dirk de VriesDepartment of Anaesthesiology, Spaarne Gasthuis, Haarlem, /Hoofddorp, The Netherlands.
Olaf DekkersDepartment of Epidemiology, Leiden University Medical Center, Leiden, The Netherlands.
Wilbert van den HoutDepartment of Biomedical Data Science, Leiden University Medical Center, Leiden, The Netherlands.
Carmen Vleggeert-LankampDepartment of Neurosurgery, Leiden University Medical Center, Leiden, The Netherlands.
Leiden University Medical Center · NLSpaarne Ziekenhuis · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSciatica is a condition that is characterised by radicular pain in the leg and primarily caused by a herniated lumbar intervertebral disk. In addition to leg pain, patients can experience back pain, leg numbness and leg weakness resulting in decreased productivity and social activity. The majority of sciatica cases recovers spontaneously and therefore patients are initially treated conservatively with oral pain medication. However, some patients experience intractable pain that severely impedes them and no consensus exists on the optimal conservative treatment to reduce this discomfort in the acute phase of sciatica. The aim of the TEIAS trial is to assess the effectiveness, cost-effectiveness and predictive capability on patient outcome of transforaminal epidural injection (TEI) compared to treatment with standard pain medication.

methodsThis study is designed as a prospective, open-label, mono-centered, randomized controlled trial. Patients that visit their general practitioner with complaints of radicular leg pain and meet the selection criteria are asked to participate in this study. Eligible patients will be randomized to treatment with TEI or to treatment with standard oral pain medication. Treatment of TEI will comprise lidocaine with methylprednisolone acetate for L3 and below and lidocaine with dexamethasone above L3. A total of 142 patients will be recruited and follow-up will occur after 1, 2, 4, 10 and 21 weeks for assessment of pain, functionality, patient received recovery and cost-effectiveness. The primary outcome will be the average score for leg pain at 2 weeks. For this outcome we defined a clinically relevant difference as 1.5 on the 11-point NRS scale. DISCUSSION: Adequate conservative treatment in the acute phase of sciatica is lacking, particularly for patients with severe symptoms. Focusing on effectiveness, cost-effectiveness and predictive capability on patient outcome of TEI will produce useful information allowing for more lucid decision making in the conservative treatment of sciatica in the acute phase.

trial registrationThis trial is registered in the ClinicalTrials.gov database under registry number NCT03924791 on April 23, 2019.

Indexed as

Cost-Benefit AnalysisDexamethasoneHumansInjections, EpiduralIntervertebral Disc DegenerationIntervertebral Disc DisplacementLumbar VertebraePainPain MeasurementProspective StudiesRandomized Controlled Trials as TopicSciaticaDexamethasoneAcute sciaticaCost-effectivenessHerniated intervertebral diskLeg painLumbar spineLumbar surgeryProlonged conservative treatmentRandomized controlled trialTransforaminal epidural injection

Identifiers

PMID31481010
PMCPMC6719366
OpenAlexW2972255422

What OpenQuestion holds

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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.