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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN26872154
Enrollment
283
Registered
2003-08-07
Start date
2002-11-15
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe sciatica caused by a lumbar disc herniation with root compression Musculoskeletal Diseases Sciatica

Interventions

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

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 7, 2026