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透视引导下尾端硬膜外注射联合或不联合类固醇治疗腰椎管狭窄症疼痛:随机、双盲、活性对照试验的一年结果

Fluoroscopic caudal epidural injections with or without steroids in managing pain of lumbar spinal stenosis: one-year results of randomized, double-blind, active-controlled trial.

作者信息

Manchikanti Laxmaiah, Cash Kimberly A, McManus Carla D, Pampati Vidyasagar, Fellows Bert

机构信息

Pain Management Center of Paducah, Paducah, KY 42003, USA.

出版信息

J Spinal Disord Tech. 2012 Jun;25(4):226-34. doi: 10.1097/BSD.0b013e3182160068.

Abstract

STUDY DESIGN

A randomized, double-blind, active-controlled trial.

OBJECTIVE

To evaluate the effectiveness of caudal epidural injections with or without steroids in providing effective and long-lasting pain relief in the management of chronic low back pain related to lumbar spinal stenosis.

SUMMARY OF BACKGROUND DATA

Multiple interventions including surgery and interventional techniques such as epidural injections and adhesiolysis are commonly performed in managing pain related to spinal stenosis. There is continuing debate on the effectiveness of all interventions, and a paucity of literature regarding effectiveness.

METHODS

One-hundred participants were randomly assigned to 1 of the 2 groups, with Group I participants receiving caudal epidural injections of local anesthetic (lidocaine 0.5%), whereas Group II participants received caudal epidural injections with 0.5% lidocaine 9 mL mixed with 1 mL of steroid (nonparticulate Celestone).

OUTCOMES ASSESSMENT

Multiple outcome measures were used, including the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake with assessment at 3, 6, and 12 months posttreatment. Significant pain relief and improvement in disability were defined as 50% or more.

RESULTS

Overall, significant pain relief and functional status improvement (≥50%) were demonstrated in 48% in Group I and 46% in Group II. However, significant pain relief and functional status improvement were seen in 60% of the participants in both groups in the successful category when the participants were separated into successful and failed categories. The overall number of procedures was 3.1±1.3 or 3.6±1.1 in the successful category in Group I, with overall 2.9±1.4 or 3.5±1.2 in the successful category in Group II.

CONCLUSION

Caudal epidural injections of local anesthetic with or without steroids may be an effective treatment for a select group of patients with chronic function-limiting low back and lower extremity pain secondary to spinal stenosis.

摘要

研究设计

一项随机、双盲、活性对照试验。

目的

评估在治疗与腰椎管狭窄相关的慢性下腰痛时,尾端硬膜外注射含或不含类固醇药物能否有效且持久地缓解疼痛。

背景数据总结

包括手术以及硬膜外注射和粘连松解术等介入技术在内的多种干预措施常用于治疗与椎管狭窄相关的疼痛。对于所有干预措施的有效性仍存在持续争论,且关于有效性的文献较少。

方法

100名参与者被随机分配到2组中的1组,第一组参与者接受尾端硬膜外注射局部麻醉剂(0.5%利多卡因),而第二组参与者接受尾端硬膜外注射9毫升0.5%利多卡因与1毫升类固醇(非颗粒性倍他米松磷酸钠)的混合液。

结果评估

采用多种结果测量指标,包括数字评分量表(NRS)、Oswestry功能障碍指数2.0(ODI)、就业状况以及在治疗后3个月、6个月和12个月时的阿片类药物摄入量评估。显著的疼痛缓解和功能障碍改善定义为50%或更多。

结果

总体而言,第一组48%的参与者和第二组46%的参与者表现出显著的疼痛缓解和功能状态改善(≥50%)。然而,当将参与者分为成功和失败类别时,两组中60%的成功类别参与者出现了显著的疼痛缓解和功能状态改善。在第一组成功类别中,总体手术次数为3.1±1.3次或3.6±1.1次,在第二组成功类别中,总体手术次数为2.9±1.4次或3.5±1.2次。

结论

尾端硬膜外注射含或不含类固醇的局部麻醉剂可能是治疗因椎管狭窄继发的慢性功能受限性下腰和下肢疼痛的特定患者群体的有效方法。

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