Devogelaer J P, Dreiser R L, Abadie E, Avouac B, Bouvenot G, Carbonell Abello J, Kaufman J M, Koes B W, Laslop A, Lemmel E, Richy F, Rozenberg S, Tavares V, Valat J P, Reginster J Y
Rheumatology Unit, UCL 5390, St-Luc University, Hospital, Université Catholique de Louvain, Brussels, Belgium.
Clin Exp Rheumatol. 2003 Nov-Dec;21(6):691-4.
In this paper we propose guidelines for clinical trials aimed at assessing the efficacy of drugs for acute non-specific low back pain (LBP) with or without radicular pain, preliminary to their approval and registration. To this end, consensus statements were obtained from a group of experts in the fields of rheumatology, clinical medicine, public health and epidemiology. EBM resources were systematically used as references. Four diagnostic categories were defined: type 1--LBP with no radiation; type 2--LBP radiating no further than the knee; type 3--LBP radiating beyond the knee, but with no neurologic signs; and type 4--LBP radiating to a specific and entire leg dermatome, with or without neurologic signs. Studies should be designed on the basis of the claimed indications for the drug, but must be double-blinded whatever the indication. The duration of the study may be shorter for LBP type 1 or 2 (one week) than for LBP types 3 and 4 (up to one month), depending on the aim of the study and the indications for the drug. The comparator may be inactive (placebo) or active (for a superiority trial, e.g., versus paracetamol). Specific inclusion and exclusion criteria have been defined here for each category. An appropriate wash-out period for any drugs that could affect the pain status should be planned. Paracetamol may be allowed as rescue medication. The primary endpoint should be based on a validated pain assessment tool that may be either generic (type 1 or 2) or oriented (back and knee for types 3 and 4). Secondary endpoints could include the assessment of functional performance; the duration of any period of bed-rest; work limitation; a global assessment comprising pain at rest, standing and walking; the time elapsed before epidural injection, the prescription of other therapeutic agents, or surgery; and the use of rescue medication. Adverse events (AE) should be monitored systematically using a methodology that reflects the mode of action of the tested drug. With the application of these guidelines, LBP could serve as an appropriate disease for testing analgesic drugs. Rigorous evaluation may also help to improve the management of acute LBP.
在本文中，我们提出了针对旨在评估治疗伴有或不伴有神经根性疼痛的急性非特异性腰痛（LBP）药物疗效的临床试验指南，作为其批准和注册的前期准备。为此，我们从风湿病学、临床医学、公共卫生和流行病学领域的一组专家那里获得了共识声明。循证医学资源被系统地用作参考。定义了四种诊断类别：1型——无放射痛的腰痛；2型——放射至膝部以下的腰痛；3型——放射至膝部以上但无神经体征的腰痛；4型——放射至特定且整个腿部皮节的腰痛，伴有或不伴有神经体征。研究应根据药物所宣称的适应症进行设计，但无论适应症如何，都必须采用双盲试验。根据研究目的和药物适应症，1型或2型腰痛（一周）的研究持续时间可能比3型和4型腰痛（最长一个月）短。对照物可以是无活性的（安慰剂）或有活性的（用于优效性试验，例如与对乙酰氨基酚对比）。这里为每个类别定义了具体的纳入和排除标准。对于任何可能影响疼痛状态的药物，应计划适当的洗脱期。可以允许使用对乙酰氨基酚作为急救药物。主要终点应基于经过验证的疼痛评估工具，该工具可以是通用的（1型或2型）或针对性的（3型和4型针对背部和膝部）。次要终点可包括功能表现评估；任何卧床休息期的持续时间；工作限制；包括静息、站立和行走时疼痛的总体评估；硬膜外注射、使用其他治疗药物或手术前经过的时间；以及急救药物的使用。应使用反映受试药物作用方式的方法系统地监测不良事件（AE）。通过应用这些指南，LBP可作为测试镇痛药的合适疾病。严格的评估也可能有助于改善急性LBP的管理。
