Conservative treatment in patients with an acute lumbosacral radicular syndrome: design of a randomised clinical trial [ISRCTN68857256].
BACKGROUND
The objective is to present the design of randomised clinical trial (RCT) on the effectiveness of physical therapy added to general practitioners management compared to general practitioners management only in patients with an acute lumbosacral radicular syndrome (also called sciatica).


METHODS
Patients in general practice diagnosed with an acute (less than 6 weeks) lumbosacral radicular syndrome and an age above 18 years are eligible for participation. The general practitioners treatment follows their clinical guideline. The physical therapy treatment will consist of patient education and exercise therapy. The primary outcome measure is patients reported global perceived effect. Secondary outcome measures are severity of complaints, functional status, health status, fear of movement, medical consumption, sickness absence, costs and treatment preference. The follow-up is 52 weeks.


CONCLUSIONS
Treatment by general practitioners and physical therapists in this study will be transparent and not a complete "black box". The results of this trial will contribute to the decision of the general practitioner regarding referral to physical therapy in patients with an acute lumbosacral radicular syndrome.
Luijsterburg
Pim A J
PA
General Practice, University Medical Center Rotterdam (Erasmus MC), PO Box 1736, 3000 DR Rotterdam, The Netherlands. p.luijsterburg@erasmusmc.nl
Verhagen
Arianne P
AP
Ostelo
Raymond W J G
RW
van den Hoogen
Hans J M M
HJ
Peul
Wilco C
WC
Avezaat
Cees J J
CJ
Koes
Bart W
BW
D000208:Acute Disease; D006801:Humans; D015337:Multicenter Studies as Topic / Q000379:methods; D009426:Netherlands; D026741:Physical Therapy Modalities; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D012107:Research Design; D018401:Sample Size; D012585:Sciatica / Q000534:rehabilitation*