A multicentre randomised cost-effectiveness trial concerning the timing of surgery for sciatica caused by a lumbar disc herniation
| ISRCTN | ISRCTN26872154 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26872154 |
| Secondary identifying numbers | 945-02-035 |
- Submission date
- 02/07/2003
- Registration date
- 07/08/2003
- Last edited
- 24/07/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Wilco C. Peul
Scientific
Scientific
Department of Neurosurgery LUMC
Leiden University Medical Center
Albinusdreef 2
Leiden
2333 ZA
Netherlands
| Phone | +31 (0)71 5262109 |
|---|---|
| w.c.peul@lumc.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | A multicentre randomised cost-effectiveness trial concerning the timing of surgery for sciatica caused by a lumbar disc herniation |
| Study acronym | The Sciatica Trial |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 28/02/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 280 were necessary, 283 were included |
| Key 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. |
| Key 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 |
| Date of first enrolment | 15/11/2002 |
| Date of final enrolment | 28/02/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden University Medical Center
Leiden
2333 ZA
Netherlands
2333 ZA
Netherlands
Sponsor information
The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Research organisation
Research organisation
Laan van Nieuw Oost Indie 334
P.O. Box 93245
The Hague
2509 AE
Netherlands
| Phone | +31 (0)70 3495111 |
|---|---|
| info@zonmw.nl | |
"ROR" |
https://ror.org/01yaj9a77 |
Funders
Funder type
Research organisation
Netherlands Organisation for Health Research and Development
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Netherlands Organisation for Health Research and Development
- Location
- Netherlands
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 11/02/2005 | Yes | No | |
| Results article | results | 31/05/2007 | Yes | No | |
| Results article | results | 10/11/2007 | Yes | No | |
| Other publications | cost-utility analysis | 14/06/2008 | Yes | No | |
| Results article | results | 14/06/2008 | Yes | No | |
| Results article | results | 14/03/2013 | Yes | No | |
| Results article | results | 01/12/2013 | Yes | No | |
| Results article | results | 29/10/2014 | Yes | No |
