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Open Access Study protocol

Conservative treatment in patients with an acute lumbosacral radicular syndrome: design of a randomised clinical trial [ISRCTN68857256]

Pim AJ Luijsterburg1*, Arianne P Verhagen1, Raymond WJG Ostelo2, Hans JMM van den Hoogen3, Wilco C Peul4, Cees JJ Avezaat5 and Bart W Koes1

Author Affiliations

1 General Practice, University Medical Center Rotterdam (Erasmus MC), PO Box 1736, 3000 DR Rotterdam, The Netherlands

2 EMGO Institute, University Medical Center (VU), Van der boechorsstraat 7, 1081 BT Amsterdam, The Netherlands

3 General Practice, J v/d Diesduncstraat 18, 5721 VM Asten, The Netherlands

4 Neurosurgery, Leids University Medical Center (LUMC), PO Box 9600, 2300 RC Leiden, The Netherlands

5 Neurosurgery, University Medical Center Rotterdam (Erasmus MC), PO Box 1736, 3000 DR Rotterdam, The Netherlands

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BMC Musculoskeletal Disorders 2004, 5:39  doi:10.1186/1471-2474-5-39

Published: 9 November 2004

Abstract

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/Design

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.

Discussion

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.