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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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17 October 2016 |
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Main ID: |
ISRCTN26872154 |
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Date of registration:
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07/08/2003 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A multicentre randomised cost-effectiveness trial concerning the timing of surgery for sciatica caused by a lumbar disc herniation
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Scientific title:
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A multicentre randomised cost-effectiveness trial concerning the timing of surgery for sciatica caused by a lumbar disc herniation |
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Date of first enrolment:
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15/11/2002 |
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Target sample size:
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283 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN26872154 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Treatment)
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Phase:
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Wilco C.
Peul |
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Address:
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Department of Neurosurgery LUMC
Leiden University Medical Center
Albinusdreef 2
2333 ZA
Leiden
Netherlands |
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Telephone:
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+31 (0)71 5262109 |
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Email:
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w.c.peul@lumc.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Severe sciatica caused by a lumbar disc herniation with root compression
Musculoskeletal Diseases
Sciatica
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Intervention(s)
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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
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Primary Outcome(s)
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1. Roland Disability Questionnaire
2. Visual Analogue Scale (VAS) leg pain
3. Global perceived recovery during the first year after randomisation
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Secondary Outcome(s)
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1. 36-item Short Form health survey
2. VAS back pain
3. Sciatica frequency and bothersomeness index
4. PROLO scale
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Secondary ID(s)
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945-02-035
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Source(s) of Monetary Support
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Netherlands Organisation for Health Research and Development
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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