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经椎间孔高压生理盐水治疗腰椎侧隐窝狭窄症:一项双盲、随机、阳性药物对照试验。

Transforaminal hypertonic saline for the treatment of lumbar lateral canal stenosis: a double-blinded, randomized, active-control trial.

机构信息

Department of Anesthesiology and Pain Medicine, Asan Medical Center, University of Ulsan, College of Medicine, Korea.

出版信息

Pain Physician. 2013 May-Jun;16(3):197-211.


DOI:
PMID:23703407
Abstract

BACKGROUND: Degenerative lumbar spinal stenosis is one of the most common causes of chronic lower back pain and radiculopathy. Spinal stenosis is anatomically classified as central and lateral spinal canal stenosis. Many treatment modalities and techniques, including surgery and epidural injection, have been used to manage the pain. However, the effect of hypertonic saline injection via the transforaminal approach has not yet been studied. OBJECTIVES: The aim of this study is to determine the effect of adding hypertonic saline to conventional transforaminal epidural steroid injections (TFEI) to provide pain relief for chronic radiculopathy patients secondary to lateral canal spinal stenosis. STUDY DESIGN: A double-blind, randomized, active-control trial. SETTING: An interventional pain management practice in a hospital, Republic of Korea. METHODS: Two groups: the hypertonic group received hypertonic saline combined with triamcinolone and the control group received normal saline combined with triamcinolone. A total of 68 patients were randomly allocated into either 2 groups by a computer-generated randomization program. Twenty-seven patients in the hypertonic group and 26 patients in the control group were assessed. A total of 53 patients were included in this analysis. Outcome measures were taken at baseline, one, 2, 3, 4, and 6 months post-procedure. The primary outcome measures included the numerical rating scale (NRS) and the proportion of substantial responders. The secondary outcome measures included the Oswestry disability index (ODI), the proportion of substantial and moderate responders, and patient satisfaction. RESULTS: Transforaminal epidural injection of steroids, with or without the addition of 10% hypertonic saline, was effective and provided significant pain relief with the improvement of functional outcome within 4 months. The addition of hypertonic saline was superior in efficacy compared with conventional TFEI at 3 months follow-up. The differences in the absolute pain scores did not demonstrate statistical significance between the 2 groups. The reduction in pain intensity from the baseline was greater in the hypertonic group and demonstrated higher rates of satisfaction. The use of hypertonic saline also extended the duration of significant pain relief to 6 months compared with baseline. LIMITATIONS: The lack of placebo group and small sample size. CONCLUSION: Superior short-term pain relieving efficacy, but limited long-term effects of hypertonic saline, when added to TFEIs.

摘要

背景:退行性腰椎管狭窄症是慢性下腰痛和神经根病最常见的原因之一。椎管狭窄在解剖学上分为中央型和侧方型椎管狭窄。许多治疗方法和技术,包括手术和硬膜外注射,已被用于治疗疼痛。然而,经椎间孔途径注射高渗盐水的效果尚未得到研究。

目的:本研究旨在确定在常规经椎间孔硬膜外类固醇注射(TFEI)中加入高渗盐水是否能为侧管狭窄引起的慢性神经根病患者提供疼痛缓解。

研究设计:双盲、随机、活性对照试验。

设置:韩国一家医院的介入性疼痛管理实践。

方法:两组:高渗组接受高渗盐水加曲安奈德,对照组接受生理盐水加曲安奈德。共有 68 名患者通过计算机生成的随机分组程序随机分配到两组。高渗组 27 例,对照组 26 例。共有 53 例患者纳入本分析。在基线、1、2、3、4 和 6 个月时进行疗效评估。主要疗效指标包括数字评分量表(NRS)和大量反应者的比例。次要疗效指标包括 Oswestry 残疾指数(ODI)、大量和中度反应者的比例以及患者满意度。

结果:TFEI 中加入或不加入 10%高渗盐水的类固醇治疗是有效的,可显著缓解疼痛,并在 4 个月内改善功能结局。在 3 个月的随访中,高渗盐水组的疗效优于常规 TFEI。两组之间的绝对疼痛评分差异无统计学意义。与基线相比,高渗组的疼痛强度降低更大,满意度更高。与基线相比,高渗盐水还将显著缓解疼痛的持续时间延长至 6 个月。

局限性:缺乏安慰剂组和样本量小。

结论:在 TFEI 中加入高渗盐水可显著提高短期止痛效果,但长期效果有限。

相似文献

[1]
Transforaminal hypertonic saline for the treatment of lumbar lateral canal stenosis: a double-blinded, randomized, active-control trial.

Pain Physician. 2013

[2]
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[3]
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[4]
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[6]
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[7]
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[8]
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[9]
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[10]
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引用本文的文献

[1]
Epidural steroid injections in lumbar disc herniation- Evidence synthesis from 72 randomised controlled trials (RCTs) and a total of 7701 patients.

Brain Spine. 2025-3-13

[2]
Factfinders for patient safety: Epidural steroid injection in patients with lumbar spinal stenosis.

Interv Pain Med. 2024-10-22

[3]
Involvement of the spinal γ-aminobutyric acid receptor in the analgesic effects of intrathecally injected hypertonic saline in spinal nerve-ligated rats.

Korean J Pain. 2023-10-1

[4]
Comparison of Adjuvant Hypertonic Saline and Normal Saline for Epidural Block in Patients with Postherpetic Neuralgia: A Double-Blind, Randomized Trial.

Pain Res Manag. 2022

[5]
Adjuvant administration of hypertonic saline in lumbar epidural intervention may be associated with successful response in patients with probable neuropathic radicular pain Screened by Douleur Neuropathique 4.

Int J Med Sci. 2021

[6]
Kambin's Triangle Approach versus Traditional Safe Triangle Approach for Percutaneous Transforaminal Epidural Adhesiolysis Using an Inflatable Balloon Catheter: A Pilot Study.

J Clin Med. 2019-11-15

[7]
Factors for Predicting Favorable Outcome of Percutaneous Epidural Adhesiolysis for Lumbar Disc Herniation.

Pain Res Manag. 2017

[8]
Efficacy of Percutaneous Adhesiolysis in the Treatment of Lumbar Post Surgery Syndrome.

Anesth Pain Med. 2016-3-7

[9]
Safety of Epidural Corticosteroid Injections.

Drugs R D. 2016-3

[10]
Efficacy of epidural injections in the treatment of lumbar central spinal stenosis: a systematic review.

Anesth Pain Med. 2015-2-1

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