Prolonged conservative care versus early surgery in patients with sciatica caused by lumbar disc herniation: two year results of a randomised controlled trialBMJ 2008; 336 doi: https://doi.org/10.1136/bmj.a143 (Published 12 June 2008) Cite this as: BMJ 2008;336:1355
- Wilco C Peul, neurosurgeon, epidemiologist12,
- Wilbert B van den Hout, health economist3,
- Ronald Brand, statistician4,
- Ralph T W M Thomeer, head of department1,
- Bart W Koes, head of department5,
- for the Leiden-The Hague Spine Intervention Prognostic Study Group
- 1Department of Neurosurgery, Leiden University Medical Centre, PO Box 9600, 2300 RC Leiden, Netherlands
- 2Department of Neurosurgery, Medical Centre Haaglanden, The Hague, Netherlands
- 3Department of Medical Decision Making, Leiden University Medical Centre
- 4Department of Medical Statistics, Leiden University Medical Centre
- 5Research Department of General Practice, Erasmus Medical Centre, 3000 CA Rotterdam, the Netherlands
- Correspondence to: W C Peul
- Accepted 16 May 2008
Objectives To evaluate the effects of early lumbar disc surgery compared with prolonged conservative care for patients with sciatica over two years of follow-up.
Design Randomised controlled trial.
Setting Nine Dutch hospitals.
Participants 283 patients with 6-12 weeks of sciatica.
Interventions Early surgery or an intended six months of continued conservative treatment, with delayed surgery if needed.
Main outcome measures Scores from Roland disability questionnaire for sciatica, visual analogue scale for leg pain, and Likert self rating scale of global perceived recovery.
Results Of the 141 patients assigned to undergo early surgery, 125 (89%) underwent microdiscectomy. Of the 142 patients assigned to conservative treatment, 62 (44%) eventually required surgery, seven doing so in the second year of follow-up. There was no significant overall difference between treatment arms in disability scores during the first two years (P=0.25). Improvement in leg pain was faster for patients randomised to early surgery, with a significant difference between “areas under the curves” over two years (P=0.05). This short term benefit of early surgery was no longer significant by six months and continued to narrow between six months and 24 months. Patient satisfaction decreased slightly between one and two years for both groups. At two years 20% of all patients reported an unsatisfactory outcome.
Conclusions Early surgery achieved more rapid relief of sciatica than conservative care, but outcomes were similar by one year and these did not change during the second year.
Trial Registry ISRCT No 26872154.
We thank Gail Bieger for reviewing the manuscript.
Contributors: The participants in the Leiden-The Hague Spine Intervention Prognostic Study Group were: protocol committee, WCP, BWK, and RTWMT; steering committee, BWK, RTWMT, JAH Eekhof, JTJ Tans, WBvdH, WCP, RB, and HC van Houwelingen; statistical analysis, WBvdH; research nurses and data collection and management, M Nuyten, P Bergman, G Holtkamp, S Dukker, A Mast, L Smakman, C Waanders, L Polak, A Nieborg; coordinating physicians of participating hospitals, JTJ Tans, R Walchenbach (Medical Center Haaglanden, The Hague), J van Rossum, P Schutte, RTWMT (Diaconessen Hospital, Leiden), GAM Verheul, JE Dalman, JAL Wurzer (Groene Hart Hospital, Gouda), JWA Sven, A Kloet (Reinier de Graaf Hospital, Delft/Voorburg), ISJ Merkies, H van Dulken (Spaarne Hospital, Heemstede/Haarlem), PCLA Lambrechts, JAL Wurzer (Bronovo Hospital, The Hague), RWM Keunen, CFE Hoffmann (Haga Hospital, The Hague), J Haan, H van Dulken (Rijnland Hospital, Leiderdorp/Alphen ad Rijn), R Groen, RRF Kuiters (Lange Land Hospital, Zoetermeer), RAC Roos, JHC Voormolen (Leiden University Medical Center, Leiden), JAH Eekhof (Public Health and Primary Care, Leiden University, Leiden). WCP is guarantor for the study.
Funding: This study was funded by grants from the Health Care Efficiency Research Program of Netherlands Organisation for Health Research and Development (ZonMw) and the Hoelen Foundation, The Hague.
Competing interests: None declared.
Ethical approval: The participating hospitals’ medical ethics committees each approved the study protocol.