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Abstract
BackgroundThe 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/designPatients 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.DiscussionEvidence 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.
Highlights
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
One of the greatest advantages of publishing the design of a randomized controlled trial (RCT) before results are available is the accessibility to criticism of the methodological quality irrespective of the results
But not less important, publishing the design of a RCT is instrumented in preventing publication bias in subsequent meta-analyses
Summary
In this article the rationale and design of a pragmatic RCT on the cost-effectiveness of timing of disc surgery for LSRS is described. The study is pragmatic because it acknowledges that sometimes it may not be possible to postpone surgery for every conservative care patient until 6 months after allocation and that some patients will recover before surgery is performed in the surgical group. In these cases we consider it unethical to hold on to the randomized treatment. Because of the Intent-to-Treat analysis these cases will be analysed in their own allocated randomization arm and will not cause methodological problems because it is two healthcare strategies that are compared, as opposed to two treatments The objective of this trial is to provide evidence on the preferred timing of disc surgery for sciatica. The intended size of the study population is sufficiently large to detect short and long term differences between both strategies
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