Welcome
Support Centre
23 September 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
A multicentre randomised cost-effectiveness trial concerning the timing of surgery for sciatica caused by a lumbar disc herniation
ISRCTN ISRCTN26872154
DOI 10.1186/ISRCTN26872154
ClinicalTrials.gov identifier
EudraCT number
Public title A multicentre randomised cost-effectiveness trial concerning the timing of surgery for sciatica caused by a lumbar disc herniation
Scientific title
Acronym The Sciatica Trial
Serial number at source 945-02-035
Study hypothesis Lumbar disc surgery is often performed in patients who have sciatica that does not resolve within six weeks, but the optimal timing of surgery is not known. Guidelines advise to discuss surgery with patients after six weeks of sciatica. This statement is not scientifically based and investigated by the current randomised controlled trial (RCT).
Lay summary Not provided at time of registration
Ethics approval Approval was granted by the Medical Ethics Committee of Leiden University Medical Center on the 20th December 2001 (ref: P178/98).
Study design Randomised controlled trial
Countries of recruitment Netherlands
Disease/condition/study domain Severe sciatica caused by a lumbar disc herniation with root compression
Participants - inclusion criteria Patients (18 - 65 years old) with at least 6 weeks and a maximum of 12 weeks sciatica not reacting to conservative treatment. An indication for surgery is made by the clinical picture with magnetic resonance imaging (MRI) confirmation of a lumbar disc herniation.
Participants - exclusion criteria 1. Cauda equina syndrome
2. Severe paresis (MRC less than 3)
3. Identical complaints in the past twelve months
4. A history of spine surgery, bony stenosis, spondylolisthesis
5. Pregnancy
6. Severe comorbidity
Anticipated start date 15/11/2002
Anticipated end date 28/02/2005
Status of trial Completed
Patient information material
Target number of participants 280 were necessary, 283 were included
Interventions 1. Surgery as soon as possible and within two weeks after randomisation
2. Prolonged conservative treatment by the General Practitioner. If natural history leads to aggravation of sciatica or does not result in some recovery 6 months after randomisation, 'late surgery' will be performed
Primary outcome measure(s) 1. Roland Disability Questionnaire
2. Visual Analogue Scale (VAS) leg pain
3. Global perceived recovery during the first year after randomisation
Secondary outcome measure(s) 1. 36-item Short Form health survey
2. VAS back pain
3. Sciatica frequency and bothersomeness index
4. PROLO scale
Sources of funding The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Trial website
Publications 1. 2005 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/15707491
2. 2007 results in: http://www.ncbi.nlm.nih.gov/pubmed/17538084
3. 2007 results in: http://www.ncbi.nlm.nih.gov/pubmed/18062596 (in Dutch)
4. 2008 cost-utility analysis in: http://www.ncbi.nlm.nih.gov/pubmed/18502912
5. 2008 results in: http://www.ncbi.nlm.nih.gov/pubmed/18502911
6. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23484826
7. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24138062
Contact name Dr  Wilco C.  Peul
  Address Department of Neurosurgery LUMC
Leiden University Medical Center
Albinusdreef 2
  City/town Leiden
  Zip/Postcode 2333 ZA
  Country Netherlands
  Tel +31 (0)71 5262109
  Fax +31 (0)71 5248221
  Email w.c.peul@lumc.nl
Sponsor The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
  Address Laan van Nieuw Oost Indie 334
P.O. Box 93245
  City/town The Hague
  Zip/Postcode 2509 AE
  Country Netherlands
  Tel +31 (0)70 3495111
  Fax +31 (0)70 3495100
  Email info@zonmw.nl
Date applied 02/07/2003
Last edited 24/10/2013
Date ISRCTN assigned 07/08/2003
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.