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一项在慢性轴向或椎间盘源性下腰痛患者中进行的透视下腰椎间孔硬膜外注射的随机、双盲、阳性药物对照试验:2 年随访结果。

A randomized, double-blind, active-controlled trial of fluoroscopic lumbar interlaminar epidural injections in chronic axial or discogenic low back pain: results of 2-year follow-up.

机构信息

Pain Management Center of Paducah, Paducah, KY; and University of Louisville, Louisville, KY; and Millennium Pain Center, Bloomington, IL, and University of Illinois, Urbana-Champaign, IL.

出版信息

Pain Physician. 2013 Sep-Oct;16(5):E491-504.

PMID:24077199
Abstract

BACKGROUND

Chronic low back with or without lower extremity pain is extremely common, expensive, and disabling. However, all modalities of treatments are directed towards disc herniation which is responsible for a very small proportion of the patients. Thus, chronic low back pain without disc herniation is common. Multiple modalities of treatments are utilized in managing axial or discogenic pain including surgery and epidural injections including surgery, intradiscal therapies, and epidural injections. However, there is continued debate on the effectiveness, indications, and medical necessity of all modalities treatments in managing axial or discogenic pain in the lumbar spine.

STUDY DESIGN

A randomized, double-blind, active control trial.

SETTING

A private practice, specialty referral, interventional pain management practice in the United States.

OBJECTIVES

To evaluate the ability to assess the effectiveness of lumbar interlaminar epidural injections in managing chronic axial or discogenic low back pain with epidural injections of local anesthetic with or without steroids.

METHODS

In this study, a total of 120 patients were randomly allocated to one of the 2 groups receiving either local anesthetic alone or local anesthetic with steroids with 60 patients in each group. The primary outcome measure was at least 50% improvement in the numeric rating scale (NRS) and Oswestry Disability Index (ODI). Outcomes were assessed at 3, 6, 12, 18, and 24 months post treatment.

RESULTS

Significant pain relief and functional status improvement defined as at least 50% or more reduction in scores from baseline were observed in 72% of patients receiving local anesthetic alone and 67% of the patients receiving local anesthetic with steroids. Opioid intake was reduced from baseline in each group for 2 years.

LIMITATIONS

The results of the study are limited by the lack of a placebo group.

CONCLUSION

Lumbar interlaminar epidural injections of local anesthetic with or without steroids are effective in patients with chronic axial low back pain of discogenic origin without facet joint pain, disc herniation, and/or radiculitis.

TRIAL REGISTRATION

NCT00681447.

摘要

背景

慢性下腰痛伴或不伴下肢疼痛极为常见,且费用高昂,使人丧失劳动能力。然而,所有治疗方式都是针对椎间盘突出症的,而这种病症仅占患者的很小一部分。因此,无椎间盘突出的慢性下腰痛很常见。治疗轴向或椎间盘源性疼痛的方法有多种,包括手术和硬膜外注射,包括手术、椎间盘内治疗和硬膜外注射。然而,对于管理腰椎轴向或椎间盘源性疼痛的所有治疗方式的有效性、适应证和医学必要性仍存在持续争议。

研究设计

一项随机、双盲、活性对照试验。

设置

美国私人执业、专科转诊、介入性疼痛管理实践。

目的

评估在硬膜外注射局麻药(单独或联合类固醇)治疗慢性轴向或椎间盘源性下腰痛时,评估腰椎间硬膜外注射的有效性的能力。

方法

在这项研究中,共 120 名患者随机分配到两组中的一组,一组接受单纯局麻药治疗,另一组接受局麻药联合类固醇治疗,每组 60 名患者。主要结局测量指标是数字评分量表(NRS)和 Oswestry 残疾指数(ODI)至少改善 50%。在治疗后 3、6、12、18 和 24 个月评估结果。

结果

单纯接受局麻药治疗的患者中有 72%和接受局麻药联合类固醇治疗的患者中有 67%出现了明显的疼痛缓解和功能状态改善,定义为基线评分至少降低 50%或更多。两组患者的阿片类药物摄入量在 2 年内均从基线水平降低。

局限性

研究结果受到缺乏安慰剂组的限制。

结论

腰椎间硬膜外注射局麻药(单独或联合类固醇)对无小关节疼痛、椎间盘突出症和/或神经根炎的椎间盘源性慢性轴向下腰痛患者有效。

试验注册

NCT00681447。

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