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

Plain English Summary

Not provided at time of registration

Study website

Type

Scientific

Contact name

Dr Wilco C. Peul

ORCID ID

Contact details

Department of Neurosurgery LUMC
Leiden University Medical Center
Albinusdreef 2
Leiden
2333 ZA
Netherlands
+31 (0)71 5262109
w.c.peul@lumc.nl

EudraCT/CTIS number

IRAS number

ClinicalTrials.gov number

Protocol/serial number

945-02-035

Scientific title

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

Acronym

The Sciatica Trial

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).

Ethics approval(s)

Medical Ethics Committee of Leiden University Medical Center, 20/12/2001, ref: P178/98

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Study setting(s)

Hospital

Study type

Treatment

Patient information sheet

Condition

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

1. Roland Disability Questionnaire
2. Visual Analogue Scale (VAS) leg pain
3. Global perceived recovery during the first year after randomisation

Secondary outcome measures

1. 36-item Short Form health survey
2. VAS back pain
3. Sciatica frequency and bothersomeness index
4. PROLO scale

Overall study start date

15/11/2002

Overall study end date

28/02/2005

Reason abandoned (if study stopped)

Participant 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.

Participant type(s)

Patient

Age group

Adult

Lower age limit

18 Years

Sex

Both

Target number of participants

280 were necessary, 283 were included

Participant 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

Recruitment start date

15/11/2002

Recruitment end date

28/02/2005

Countries of recruitment

Netherlands

Study participating centre

Leiden University Medical Center
Leiden
2333 ZA
Netherlands

Organisation

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Sponsor details

Laan van Nieuw Oost Indie 334
P.O. Box 93245
The Hague
2509 AE
Netherlands
+31 (0)70 3495111
info@zonmw.nl

Sponsor type

Research organisation

Website

ROR

https://ror.org/01yaj9a77

Funder type

Research organisation

Funder name

Netherlands Organisation for Health Research and Development

Alternative name(s)

Netherlands Organisation for Health Research and Development

Funding Body Type

private sector organisation

Funding Body Subtype

Other non-profit organizations

Location

Netherlands

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Individual participant data (IPD) sharing plan

IPD sharing plan summary

Not provided at time of registration

Study outputs