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Open Access Highly Accessed Study protocol

Prolonged conservative treatment or 'early' surgery in sciatica caused by a lumbar disc herniation: rationale and design of a randomized trial [ISRCT 26872154]

Wilco C Peul12*, Hans C van Houwelingen1, Wilbert B van der Hout3, Ronald Brand1, Just AH Eekhof4, Joseph ThJ Tans5, Ralph TWM Thomeer1 and Bart W Koes6

Author Affiliations

1 Department of Neurosurgery, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, The Netherlands

2 Department of Medical Statistics, Leiden University Medical Center, Leiden, The Netherlands

3 Department of Medical Decision Analysis, Leiden University Medical Center, Leiden, The Netherlands

4 Department of General Practice, Leiden University Medical Center, Leiden, The Netherlands

5 Department of Neurology, Medical Center Haaglanden, The Hague, The Netherlands

6 Department of General Practice, University Medical Center Rotterdam (Erasmus MC), PO Box 1736 Rotterdam, The Netherlands

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BMC Musculoskeletal Disorders 2005, 6:8  doi:10.1186/1471-2474-6-8

Published: 11 February 2005

Abstract

Background

The design of a randomized multicenter trial is presented on the effectiveness of a prolonged conservative treatment strategy compared with surgery in patients with persisting intense sciatica (lumbosacral radicular syndrome).

Methods/design

Patients presenting themselves to their general practitioner with disabling sciatica lasting less than twelve weeks are referred to the neurology outpatient department of one of the participating hospitals. After confirmation of the diagnosis and surgical indication MRI scanning is performed. If a distinct disc herniation is discerned which in addition covers the clinically expected site the patient is eligible for randomization. Depending on the outcome of the randomization scheme the patient will either be submitted to prolonged conservative care or surgery. Surgery will be carried out according to the guidelines and between six and twelve weeks after onset of complaints. The experimental therapy consists of a prolonged conservative treatment under supervision of the general practitioner, which may be followed by surgical intervention in case of persisting or progressive disability. The main primary outcome measure is the disease specific disability of daily functioning. Other primary outcome measures are perceived recovery and intensity of legpain. Secondary outcome measures encompass severity of complaints, quality of life, medical consumption, absenteeism, costs and preference. The main research question will be answered at 12 months after randomization. The total follow-up period covers two years.

Discussion

Evidence is lacking concerning the optimal treatment of lumbar disc induced sciatica. This pragmatic randomized trial, focusses on the 'timing' of intervention, and will contribute to the decision of the general practictioner and neurologist, regarding referral of patients for surgery.