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)715262109
w.c.peul@lumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Sciatica-MED-trial

Study hypothesis

Severe sciatica caused by a lumbar disc herniation with root compression and indication for surgery based on clinical picture and Magnetic Resonance Imaging (MRI).

Microendoscopic discectomy (MED) is more (cost)-effective than open discectomy.

Ethics approval

Not provided at time of registration

Study design

Multicenter randomised double-blind clinical cost-effectiveness trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Sciatica

Intervention

Randomisation in operation room to:
1. Microendoscopic surgery
2. Conventional microsurgery

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Roland Disability Questionnaire for Sciatica (RDQ)

Secondary outcome measures

1. Perceived recovery
2. Visual anolog scale (VAS)
3. VAS of back pain and combined leg and back pain
4. McGill pain questionnaire
5. Short-Form-36 questionnaire (SF 36)
6. Sciatica frequency and bothersome index (SFBI)
7. Prolo scale

Overall trial start date

01/01/2006

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Patients (18-70 years) with at least 8 weeks sciatica not reacting to conservative treatment. An indication for surgery is made by the clinical picture with MRI confirmation of a lumbar disc herniation.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/01/2006

Recruitment end date

31/12/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Department of Neurosurgery LUMC
Leiden
2333 ZA
Netherlands

Sponsor information

Organisation

Dutch Health Care Insurance Board (College voor Zorgverzekeringen [CVZ]) (Netherlands)

Sponsor details

Postbus 320
Diemen
1110AH
Netherlands
+31 (0)207978555
info@cvz.nl

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Dutch Health Care Insurance Board (College voor Zorgverzekeringen [CVZ]) (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. 2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/16696861
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19584344
3. 2010 subgroup analysis in http://www.ncbi.nlm.nih.gov/pubmed/20547620
4. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21623248

Publication citations

  1. Protocol

    Arts MP, Peul WC, Brand R, Koes BW, Thomeer RT, Cost-effectiveness of microendoscopic discectomy versus conventional open discectomy in the treatment of lumbar disc herniation: a prospective randomised controlled trial [ISRCTN51857546]., BMC Musculoskelet Disord, 2006, 7, 42, doi: 10.1186/1471-2474-7-42.

  2. Results

    Arts MP, Brand R, van den Akker ME, Koes BW, Bartels RH, Peul WC, , Tubular diskectomy vs conventional microdiskectomy for sciatica: a randomized controlled trial., JAMA, 2009, 302, 2, 149-158, doi: 10.1001/jama.2009.972.

  3. Subgroup analysis

    Arts MP, Brand R, Koes BW, Peul WC, Effect modifiers of outcome of surgery in patients with herniated disc related sciatica? A subgroup analysis of a randomised clinical trial., J. Neurol. Neurosurg. Psychiatr., 2010, 81, 11, 1265-1274, doi: 10.1136/jnnp.2009.192906.

  4. Results

    van den Akker ME, Arts MP, van den Hout WB, Brand R, Koes BW, Peul WC, Tubular diskectomy vs conventional microdiskectomy for the treatment of lumbar disk-related sciatica: cost utility analysis alongside a double-blind randomized controlled trial., Neurosurgery, 2011, 69, 4, 829-35; discussion 835-6, doi: 10.1227/NEU.0b013e31822578f6.

Editorial Notes