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经椎间孔 versus 侧旁正中 versus 正中入路腰椎硬膜外类固醇注射治疗单侧神经根性腰痛:一项随机双盲试验。

Transforaminal Versus Lateral Parasagittal Versus Midline Interlaminar Lumbar Epidural Steroid Injection for Management of Unilateral Radicular Lumbar Pain: A Randomized Double-Blind Trial.

机构信息

Department of Anesthesia and Intensive care, Post Graduate Institute of Medical Education and Research, Chandigarh, India.

Department of Anesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, Chandigarh, India.

出版信息

Pain Physician. 2019 Nov;22(6):561-573.

Abstract

BACKGROUND

Epidural steroid injections (ESIs) are commonly used for management of lumbosacral radicular pain. Midline interlaminar (MIL) or transforaminal (TF) routes are commonly used. The TF route, although associated with higher delivery of drug to the ventral epidural space, has serious complications including spinal cord injury and permanent paralysis reported in literature. Therefore, there is a search for a technically better route with fewer complications and greater drug delivery into the ventral epidural space. Recently, a parasagittal interlaminar (PIL) approach has been defined.

OBJECTIVES

We conducted this study to compare therapeutic effectiveness of 3 techniques of ESIs in patients having unilateral lumbar radiculopathy. Further, effect of ESI on bone mineral density (BMD) and serum osteocalcin levels were studied.

STUDY DESIGN

Randomized double-blind trial.

SETTING

Pain clinic of a tertiary care hospital.

METHODS

Sixty-five patients were randomly allocated into group MIL, group PIL, and group TF to receive epidural injection with 80 mg of methylprednisolone and 2 mL of 2% lidocaine. Effective pain relief and improvement in disability were assessed using Visual Analog Scale (VAS) and Modified Oswestry Disability Questionnaire (MODQ) scores at 2 weeks, 4 weeks, 3 months, and 6 months, respectively. Patients with < 50% relief received additional injection. Primary outcome of study was effective pain relief at 6 months. Mean change in VAS and MODQ scores, BMD, and serum osteocalcin levels were secondary outcome assessed.

RESULTS

Patients having effective pain relief were significantly higher in group PIL (16 of 20 [80%]) and group TF (15 of 20 [75%]) compared with group MIL. Patients receiving ESI in group PIL and group TF showed significantly lower VAS scores than group MIL (P = 0.02, P = 0.50 at 3 months and P = 0.00, P = 0.02 at 6 months, respectively). Mean MODQ scores in group PIL and group TF were significantly lower than group MIL. However, group PIL and group TF did not significantly differ in MODQ scores. There was no significant change in serum osteocalcin and BMD, as assessed by dual energy x-ray absorptiometry scan at 3 months.

LIMITATIONS

The absence of a placebo control group, small sample size, and relatively short follow-up of 6 months were limitations.

CONCLUSIONS

PIL approach is equivalent to TF and superior to MIL approach in terms of effective pain relief and decrease in disability in patients with unilateral lumbar radiculopathy. This study showed no deleterious effect on BMD.

KEY WORDS

Epidural steroid, technique, efficacy, bone marrow density, serum osteocalcin.

摘要

背景

硬膜外类固醇注射(ESIs)常用于治疗腰骶神经根痛。常用的入路有中线上(MIL)或椎间孔(TF)。TF 入路虽然与将药物更有效地递送到腹侧硬膜外腔有关,但文献中也报道了严重的并发症,包括脊髓损伤和永久性瘫痪。因此,人们一直在寻找一种技术上更好、并发症更少、药物向腹侧硬膜外腔输送更多的方法。最近,定义了一种旁正中椎间(PIL)入路。

目的

我们进行这项研究是为了比较单侧腰椎神经根病患者接受三种 ESIs 技术的治疗效果。此外,还研究了 ESI 对骨密度(BMD)和血清骨钙素水平的影响。

研究设计

随机双盲试验。

设置

三级医院疼痛诊所。

方法

将 65 名患者随机分配到 MIL 组、PIL 组和 TF 组,接受 80mg 甲基强的松龙和 2ml2%利多卡因的硬膜外注射。分别在 2 周、4 周、3 个月和 6 个月时使用视觉模拟量表(VAS)和改良 Oswestry 残疾问卷(MODQ)评分评估有效止痛和残疾改善情况。<50%缓解的患者接受额外注射。研究的主要结局是 6 个月时的有效止痛。次要结局评估了 VAS 和 MODQ 评分、BMD 和血清骨钙素水平的平均变化。

结果

与 MIL 组相比,PIL 组(20 例中有 16 例[80%])和 TF 组(20 例中有 15 例[75%])有有效止痛的患者明显更多。PIL 组和 TF 组接受 ESI 治疗的患者 VAS 评分明显低于 MIL 组(P=0.02,P=0.50 时为 3 个月,P=0.00,P=0.02 时为 6 个月)。PIL 组和 TF 组的 MODQ 评分均明显低于 MIL 组。然而,PIL 组和 TF 组在 MODQ 评分上没有显著差异。3 个月时双能 X 线吸收仪扫描显示血清骨钙素和 BMD 无明显变化。

局限性

缺乏安慰剂对照组、样本量小以及相对较短的 6 个月随访是局限性。

结论

PIL 入路在单侧腰椎神经根病患者的有效止痛和残疾程度降低方面与 TF 入路等效,优于 MIL 入路。本研究未显示对 BMD 有不良影响。

关键词

硬膜外类固醇、技术、疗效、骨髓密度、血清骨钙素。

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