Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

945-02-035

Study information

Scientific title

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

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial 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

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

15/11/2002

Overall trial end date

28/02/2005

Reason abandoned

Eligibility

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

Patient

Age group

Adult

Gender

Not Specified

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

Locations

Countries of recruitment

Netherlands

Trial participating centre

Department of Neurosurgery LUMC
Leiden
2333 ZA
Netherlands

Sponsor information

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

Funders

Funder type

Research organisation

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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

Publication citations

  1. Protocol

    Peul WC, van Houwelingen HC, van der Hout WB, Brand R, Eekhof JA, Tans JT, Thomeer RT, Koes BW, Prolonged conservative treatment or 'early' surgery in sciatica caused by a lumbar disc herniation: rationale and design of a randomized trial [ISRCT 26872154]., BMC Musculoskelet Disord, 2005, 6, 8, doi: 10.1186/1471-2474-6-8.

  2. Results

    Peul WC, van Houwelingen HC, van den Hout WB, Brand R, Eekhof JA, Tans JT, Thomeer RT, Koes BW, , Surgery versus prolonged conservative treatment for sciatica., N. Engl. J. Med., 2007, 356, 22, 2245-2256, doi: 10.1056/NEJMoa064039.

  3. Results

    el Barzouhi A, Vleggeert-Lankamp CL, Lycklama à Nijeholt GJ, Van der Kallen BF, van den Hout WB, Jacobs WC, Koes BW, Peul WC, , Magnetic resonance imaging in follow-up assessment of sciatica., N. Engl. J. Med., 2013, 368, 11, 999-1007, doi: 10.1056/NEJMoa1209250.

  4. Results

    el Barzouhi A, Vleggeert-Lankamp CL, Lycklama à Nijeholt GJ, Van der Kallen BF, van den Hout WB, Koes BW, Peul WC, , Predictive value of MRI in decision making for disc surgery for sciatica., J Neurosurg Spine, 2013, 19, 6, 678-687, doi: 10.3171/2013.9.SPINE13349.

  5. Peul WC, Van Houwelingen HC, Van den Hout WB, Brand R, Eekhof JA, Tans JT, Thomeer RT, Koes BW, [Early surgery or a wait-and-see policy in lumbosacral radicular syndrome: a randomized study]., Ned Tijdschr Geneeskd, 2007, 151, 45, 2512-2523.

  6. van den Hout WB, Peul WC, Koes BW, Brand R, Kievit J, Thomeer RT, , Prolonged conservative care versus early surgery in patients with sciatica from lumbar disc herniation: cost utility analysis alongside a randomised controlled trial., BMJ, 2008, 336, 7657, 1351-1354, doi: 10.1136/bmj.39583.709074.BE.

  7. Peul WC, van den Hout WB, Brand R, Thomeer RT, Koes BW, , Prolonged conservative care versus early surgery in patients with sciatica caused by lumbar disc herniation: two year results of a randomised controlled trial., BMJ, 2008, 336, 7657, 1355-1358, doi: 10.1136/bmj.a143.

Editorial Notes