Bastiaan C Ter Meulen, Johanna M van Dongen, Esther Maas, Marinus H van de Vegt, Johan Haumann, Henry C Weinstein, Raymond Ostelo
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引用次数: 0
Abstract
Objective: Transforaminal epidural steroid injections (TESIs) are widely administered for sciatica. The aim of this trial was to evaluate the effectiveness of TESIs in patients with acute sciatica (<8 wk).
Methods: This study was conducted in 2 Dutch hospitals. Participants (n=141) were randomly assigned to (1) usual care and TESI of 1 ml of 40 mg/ml Methylprednisolone plus 1 ml of 0.5% Levobupivacaine (intervention 1); (2) usual care and transforaminal epidural injection with 1 ml of 0.5% Levobupivacaine and 1 ml NaCl 0.9% (intervention 2); (3) usual care consisting of oral pain medication with or without physiotherapy (control). Co-primary outcomes were back pain and leg pain intensity, physical functioning, and recovery measured during 6-month follow-up.
Results: There were no statistically significant mean differences in co-primary outcomes between groups during follow-up, except for leg pain when comparing intervention group 1 with control (-0.96 95%CI:-1.83 to -0.09). For secondary outcomes, some statistical significant between-group differences were found for treatment satisfaction and surgery, but only when comparing intervention group 2 to control. Post hoc analyses showed a statistically significant difference in response [50% improvement of leg pain (yes/no)] between intervention 1 and the control group at 3 months and that both intervention groups used less opioids.
Discussion: Except for a statistically significant effect of TESI on leg pain for patients with acute sciatica compared with usual care, there were no differences in co-primary outcomes. Nonetheless, transforaminal epidural injections seem to be associated with less opioid use, which warrants further exploration.
目的:经孔硬膜外类固醇注射(TESIs)广泛用于治疗坐骨神经痛。本试验的目的是评估TESI在急性坐骨神经痛患者中的有效性(方法:本研究在荷兰两家医院进行。参与者(n=141)被随机分配到(1)常规护理和TESI,即1 ml 40 mg/ml甲基泼尼松加1 ml 0.5%左布比卡因(干预1);(2) 常规护理和经孔硬膜外注射1 ml 0.5%左布比卡因和1 ml 0.9%氯化钠(干预2);(3) 包括口腔疼痛药物在内的常规护理,包括或不包括理疗(对照)。共同主要结果是6个月随访期间测量的背痛和腿痛强度、身体功能和恢复情况,在治疗满意度和手术方面,组间存在一些统计学上的显著差异,但仅当将干预组2与对照组进行比较时。事后分析显示,干预1组和对照组在3个月时的反应[腿部疼痛改善50%(是/否)]存在统计学显著差异,并且两个干预组使用的阿片类药物较少。讨论:除了TESI对急性坐骨神经痛患者腿部疼痛的影响与常规治疗相比具有统计学意义外,共同主要转归没有差异。尽管如此,经孔硬膜外注射似乎与较少的阿片类药物使用有关,这值得进一步探索。
期刊介绍:
The Clinical Journal of Pain explores all aspects of pain and its effective treatment, bringing readers the insights of leading anesthesiologists, surgeons, internists, neurologists, orthopedists, psychiatrists and psychologists, clinical pharmacologists, and rehabilitation medicine specialists. This peer-reviewed journal presents timely and thought-provoking articles on clinical dilemmas in pain management; valuable diagnostic procedures; promising new pharmacological, surgical, and other therapeutic modalities; psychosocial dimensions of pain; and ethical issues of concern to all medical professionals. The journal also publishes Special Topic issues on subjects of particular relevance to the practice of pain medicine.