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


CONCLUSIONS
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.
Peul
Wilco C
WC
Department of Neurosurgery, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, The Netherlands. w.c.peul@lumc.nl
van Houwelingen
Hans C
HC
van der Hout
Wilbert B
WB
Brand
Ronald
R
Eekhof
Just A H
JA
Tans
Joseph Th J
JT
Thomeer
Ralph T W M
RT
Koes
Bart W
BW
D006801:Humans; D007405:Intervertebral Disc Displacement / Q000150:complications*; D019635:Neurosurgical Procedures; D012107:Research Design; D012585:Sciatica / Q000209:etiology* / Q000601:surgery / Q000628:therapy*; D016896:Treatment Outcome