Luijsterburg Pim A J, Verhagen Arianne P, Ostelo Raymond W J G, van den Hoogen Hans J M M, Peul Wilco C, Avezaat Cees J J, Koes Bart W
General Practice, University Medical Center Rotterdam (Erasmus MC), PO Box 1736, 3000 DR Rotterdam, The Netherlands.
BMC Musculoskelet Disord. 2004 Nov 9;5(1):39. doi: 10.1186/1471-2474-5-39.
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.
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.
目的是介绍一项随机临床试验（RCT）的设计，该试验旨在比较在全科医生治疗基础上加用物理治疗与仅采用全科医生治疗对急性腰骶神经根综合征（也称为坐骨神经痛）患者的疗效。
方法/设计：在全科医疗中被诊断为急性（少于6周）腰骶神经根综合征且年龄在18岁以上的患者有资格参与。全科医生的治疗遵循其临床指南。物理治疗将包括患者教育和运动疗法。主要结局指标是患者报告的总体感知效果。次要结局指标包括症状严重程度、功能状态、健康状况、运动恐惧、医疗消耗、病假、费用和治疗偏好。随访时间为52周。
本研究中全科医生和物理治疗师的治疗将是透明的，而不是一个完全的“黑箱”。该试验的结果将有助于全科医生决定是否将急性腰骶神经根综合征患者转诊至物理治疗。
