|
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
|
|
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
|
19/03/2013
|
|
Date ISRCTN assigned
|
07/08/2003
|
