A multicentre randomised cost-effectiveness trial concerning the timing of surgery for sciatica caused by a lumbar disc herniation

ISRCTN	ISRCTN26872154
DOI	https://doi.org/10.1186/ISRCTN26872154
Protocol serial number	945-02-035
Sponsor	The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Funder	Netherlands Organisation for Health Research and Development

Submission date: 02/07/2003
Registration date: 07/08/2003
Last edited: 24/07/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Wilco C. Peul
Scientific

Department of Neurosurgery LUMC
Leiden University Medical Center
Albinusdreef 2
Leiden
2333 ZA
Netherlands

Phone	+31 (0)71 5262109
Email	w.c.peul@lumc.nl

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	A multicentre randomised cost-effectiveness trial concerning the timing of surgery for sciatica caused by a lumbar disc herniation
Study acronym	The Sciatica Trial
Study objectives	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).
Ethics approval(s)	Medical Ethics Committee of Leiden University Medical Center, 20/12/2001, ref: P178/98
Health condition(s) or problem(s) studied	Severe sciatica caused by a lumbar disc herniation with root compression
Intervention	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
Intervention type	Procedure/Surgery
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
Key secondary outcome measure(s)	1. 36-item Short Form health survey 2. VAS back pain 3. Sciatica frequency and bothersomeness index 4. PROLO scale
Completion date	28/02/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	283
Key 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.
Key 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
Date of first enrolment	15/11/2002
Date of final enrolment	28/02/2005

Locations

Countries of recruitment

Netherlands

Study participating centre

Leiden University Medical Center

Leiden
2333 ZA
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	31/05/2007	Yes	No
Results article	results	10/11/2007	Yes	No
Results article	results	14/06/2008	Yes	No
Results article	results	14/03/2013	Yes	No
Results article	results	01/12/2013	Yes	No
Results article	results	29/10/2014	Yes	No
Protocol article	protocol	11/02/2005	Yes	No
Other publications	cost-utility analysis	14/06/2008	Yes	No