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颈椎管狭窄症的透视下硬膜外注射:一项随机、双盲、阳性对照试验的初步结果。

Fluoroscopic epidural injections in cervical spinal stenosis: preliminary results of a randomized, double-blind, active control trial.

机构信息

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

出版信息

Pain Physician. 2012 Jan-Feb;15(1):E59-70.

PMID:22270749
Abstract

BACKGROUND

Cervical spinal stenosis is a common disease that results in considerable morbidity and disability. There are multiple modalities of treatments, including surgical interventions and multiple interventional techniques including epidural injections. The literature on the effectiveness of cervical epidural steroids is sporadic. Emerging evidence for cervical interlaminar epidurals for various conditions in the cervical spine is positive; however, the effect of fluoroscopic epidural injections in cervical spinal stenosis has not been studied.

STUDY DESIGN

A randomized, double-blind, active control trial.

SETTING

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

OBJECTIVES

To evaluate the effectiveness of cervical interlaminar epidural injections with local anesthetic with or without steroids in the management of chronic neck pain with upper extremity pain in patients with cervical central spinal stenosis.

METHODS

Patients with cervical central spinal stenosis were randomly assigned to one of 2 groups: injection of local anesthetic only or local anesthetic mixed with non-particulate betamethasone. Sixty patients were included in this analysis. Randomization was performed by computer-generated random allocation sequence by simple randomization.

OUTCOMES ASSESSMENT

Multiple outcome measures were utilized including the Numeric Rating Scale (NRS), the Neck Disability Index (NDI), employment status, and opioid intake with assessment at 3, 6, and 12 months post-treatment. Significant pain relief or functional status was defined as a 50% or more reduction of NRS or NDI scores.

RESULTS

Significant pain relief was seen in 73% in Group I and 70% in Group II, in Group II showing both significat pain releif and functional status improvements. Group I's average relief per procedures was 11.3 ± 5.8 weeks; for Group II it was 8.6 ± 3.6 weeks, whereas after initial 2 procedures, average relief was 13.7 ± 8.7 weeks in Group I, and 13.6 ± 4.7 weeks in Group II. In the successful group, the average total relief in a one-year period was 42.2 ± 14.7 weeks in Group I and 34.3 ± 13.4 weeks in Group II, with 76% in Group I and 77% in Group II.

LIMITATIONS

Study limitations include the lack of a placebo group and that this is a preliminary report of only 60 patients, 30 in each group.

CONCLUSION

Patients who have chronic function-limiting pain that is secondary to cervical central stenosis might receive relief with cervical interlaminar epidurals of local anesthetic, whether with or without steroids.

CLINICAL TRIAL

NCT01071369.

摘要

背景

颈椎狭窄症是一种常见疾病,会导致相当大的发病率和残疾。有多种治疗方法,包括手术干预和多种介入技术,包括硬膜外注射。关于颈椎硬膜外类固醇治疗效果的文献报道较少。对于颈椎脊柱不同情况的颈椎间硬膜外注射有积极的新兴证据;然而,在颈椎狭窄症中,荧光透视硬膜外注射的效果尚未得到研究。

研究设计

一项随机、双盲、阳性对照试验。

设置

一家私人介入疼痛管理实践机构,是美国的一个专业转诊中心。

目的

评估在慢性颈痛伴上肢疼痛的颈椎中央椎管狭窄症患者中,局部麻醉剂联合或不联合皮质类固醇的颈椎间硬膜外注射对管理的有效性。

方法

将颈椎中央椎管狭窄症患者随机分为两组之一:仅注射局部麻醉剂或局部麻醉剂混合非颗粒倍他米松。本分析纳入 60 例患者。随机化通过简单随机化的计算机生成随机分配序列进行。

结果评估

使用多项结果测量指标,包括数字评分量表(NRS)、颈部残疾指数(NDI)、就业状况和阿片类药物摄入,并在治疗后 3、6 和 12 个月进行评估。显著疼痛缓解或功能状态定义为 NRS 或 NDI 评分降低 50%或更多。

结果

第 I 组中 73%的患者和第 II 组中 70%的患者出现明显疼痛缓解,第 II 组显示出明显的疼痛缓解和功能状态改善。第 I 组每例手术的平均缓解时间为 11.3 ± 5.8 周;第 II 组为 8.6 ± 3.6 周,而在最初的 2 次手术后,第 I 组的平均缓解时间为 13.7 ± 8.7 周,第 II 组为 13.6 ± 4.7 周。在成功组中,第 I 组和第 II 组在一年期间的平均总缓解时间分别为 42.2 ± 14.7 周和 34.3 ± 13.4 周,第 I 组和第 II 组的缓解率分别为 76%和 77%。

局限性

研究局限性包括缺乏安慰剂组以及仅 60 例患者的初步报告,每组 30 例。

结论

患有继发于颈椎中央狭窄的慢性功能受限疼痛的患者可能会从颈椎间硬膜外局部麻醉剂治疗中得到缓解,无论是否使用皮质类固醇。

临床试验

NCT01071369。

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