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Corticosteroids in sciatica


- candidate number16687
- NTR NumberNTR4457
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-mrt-2014
- Secondary IDsWC2013-062 Wet commissie VUMC
- Public TitleCorticosteroids in sciatica
- Scientific TitleTransforaminal epidural corticostero´ds versus short acting anesthetic in patients with sciatica: a prospective randomized trial
- ACRONYM
- hypothesisEpidural administration of corticosteroids in early onset sciatica gives clinically relevant pain reduction and functional recovery.
- Healt Condition(s) or Problem(s) studiedSciatica
- Inclusion criteria1. 18- 65 years of age 2. < 8 weeks sciatica 3. herniated disk on MRI as the cause of sciatica 4. correlation between symptoms and MRI findings 5. VAS 40 or more despite pain medication
- Exclusion criteria1. weakness graded MRC 3 or more 2. spine surgery at the same level 3. foraminal stenosis as the cause of symptoms 4. pregancy 5. severe comorbidity (e.g. cancer)
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jun-2014
- planned closingdate1-feb-2019
- Target number of participants260
- Interventionsthree groups: 1. pain medication only 2. epidural injection of steroids and local aneshetic 3. epidural injections of local anesthetic only
- Primary outcome1. Roland Disability Questionaire 2. Visual Analogue Scale (VAS) for back pain 3. Visual Analogue Scale (VAS) for leg pain 4. Global Perceived effect
- Secondary outcome1. satisfaction 2. use of medication 3. absenteism from work (yes- no) 4. number of operations
- Timepoints0-3-6 weeks, 3-6 months
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES B. Meulen, ter
- CONTACT for SCIENTIFIC QUERIES Raymond Ostelo
- Sponsor/Initiator Zaans Medisch Centrum, OLVG-West
- Funding
(Source(s) of Monetary or Material Support)
Zaans Medisch Centrum, OLVG-West
- PublicationsPain treatment in sciatica: the role of fluoroscopic epidural injections Ter Meulen BC, Van de Vegt M, Wouda E et al. NTVG. submitted
- Brief summarySciatica is a common condition afflicting 5-8 /1000 in the general population. During the first weeks after onset the focus is on adequate pain reduction by use of pain medication or epidural injections with steroids. The best treatment strategy is not known. Should all patients be injected? Or a subgroup? Or should patients be treated with medication only. What's the effect of different interventions? To answer this question we compare 3 treatment groups of patients with acute sciatica: 1. pain medication only 2. epidural injection of steroids and local aneshetic 3. epidural injections of local anesthetic only These are followed during 6 months. Outcomes are measured and compared using various scales including the Roland Morris scale and VAS. In addition the costs are measured in terms of absenteism from work and number of operations (secondary outcome measures)
- Main changes (audit trail)
- RECORD6-mrt-2014 - 1-nov-2016


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