经透视颈椎间硬膜外注射治疗颈椎术后综合征慢性疼痛:一项随机、双盲、主动对照试验的初步结果。

Fluoroscopic cervical interlaminar epidural injections in managing chronic pain of cervical postsurgery syndrome: 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):13-25.

DOI:
Abstract

BACKGROUND

Cervical postsurgery syndrome is common with increasing cervical surgical interventions. Cervical spine surgery may fail in a certain proportion of patients with continued pain secondary to pseudoarthrosis, adjacent segment degeneration, inadequate decompression, iatrogenic instability, facet joint arthritis, deformity, and spinal stenosis. Among the various treatments available for managing cervical postsurgery syndrome, epidural steroid injections are one of the most common nonsurgical interventions. However there have not been any systematic evaluations regarding the effectiveness of cervical epidural injections in cervical postsurgery syndrome.

STUDY DESIGN

A randomized, double-blind, active control trial.

SETTING

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

OBJECTIVES

To evaluate the effectiveness of cervical interlaminar epidural injections of local anesthetic with or without steroids in providing effective and long-lasting relief in the management of chronic neck pain and upper extremity pain in patients with cervical postsurgery syndrome, and to evaluate the differences between local anesthetic with or without steroids.

METHODS

Patients were randomly assigned to one of 2 groups: Group I patients received cervical interlaminar epidural injections of local anesthetic (lidocaine 0.5%, 5 mL); Group II patients received cervical interlaminar epidural injections with 0.5% lidocaine, 4 mL, mixed with 1 mL of nonparticulate betamethasone. The study was designed to include 120 patients with 60 patients in each group. This analysis includes 56 patients. Randomization was performed by computer-generated, random allocation sequence by simple randomization.

OUTCOMES ASSESSMENT

Outcome measures included the Numeric Rating Scale (NRS), the Neck Disability Index (NDI), employment status, and opioid intake. Assessments at baseline and 3, 6, and 12 months posttreatment. Significant pain relief was defined as 50% or more; significant improvement in NDI was defined as a reduction of 50% or more.

RESULTS

Significant pain relief (>/= 50%) was demonstrated in 71% of patients in Group I and 68% of patients in Group II. Functional status improvement was demonstrated by a reduction (> 50%) in the NDI scores in 71% of Group I and 64% of Group II at 12 months. The overall average procedures per year were 4.0 ± 0.7 in Group I and 4.1 ± 1.0 in Group II; the average total relief per year was 39.6 ± 11.8 weeks in Group I and 41.2 ± 15.8 weeks in Group II over the 52 week study period in the patients defined as successful. In the successful group, the combined pain relief and neck disability improvement was seen in 87% in Group I and 72% of the patients in Group II.

LIMITATIONS

The study results are limited by the lack of a placebo group and a preliminary report of 56 patients, 28 in each group.

CONCLUSION

Cervical interlaminar epidural injections with local anesthetic with or without steroids were effective in 67% of patients overall and 87% in Group I and 72% in Group II, in successful group patients with chronic function-limiting neck pain and upper extremity pain secondary to cervical postsurgery syndrome.

CLINICAL TRIAL

NCT01071369.

摘要

背景

颈椎术后综合征随着颈椎手术干预的增加而变得越来越普遍。由于假关节形成、相邻节段退变、减压不足、医源性不稳定、关节突关节炎、畸形和椎管狭窄等原因,部分患者颈椎手术后仍持续存在疼痛,颈椎手术可能会失败。在管理颈椎术后综合征的各种治疗方法中,硬膜外类固醇注射是最常见的非手术干预之一。然而,对于颈椎硬膜外注射在颈椎术后综合征中的有效性,还没有进行任何系统的评估。

研究设计

一项随机、双盲、阳性对照试验。

地点

美国一家专业转诊、私人介入性疼痛管理诊所。

目的

评估颈椎间硬膜外局部麻醉剂注射联合或不联合皮质类固醇治疗颈椎术后综合征慢性颈痛和上肢痛的有效性和持久性,并评估联合与不联合皮质类固醇的差异。

方法

患者被随机分配到两组之一:组 I 患者接受颈椎间硬膜外局部麻醉剂(利多卡因 0.5%,5 mL)注射;组 II 患者接受颈椎间硬膜外注射 0.5%利多卡因,4 mL,混合 1 mL 非颗粒倍他米松。该研究计划纳入 120 例患者,每组 60 例。本分析包括 56 例患者。随机化通过计算机生成的简单随机化随机分配序列进行。

结局评估

结局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。在治疗前、治疗后 3、6 和 12 个月进行评估。显著疼痛缓解定义为 50%或以上;NDI 显著改善定义为减少 50%或以上。

结果

组 I 中有 71%的患者和组 II 中有 68%的患者出现显著疼痛缓解(>/= 50%)。组 I 中有 71%的患者和组 II 中有 64%的患者 NDI 评分降低(> 50%),表明功能状态改善。在 12 个月时,组 I 中有 87%的成功患者和组 II 中有 72%的成功患者出现联合疼痛缓解和颈部功能障碍改善。

局限性

研究结果受到缺乏安慰剂组和初步报告的 56 例患者(每组 28 例)的限制。

结论

颈椎间硬膜外注射局部麻醉剂联合或不联合皮质类固醇对 67%的患者有效,组 I 中有 87%的患者和组 II 中有 72%的患者在成功组中,这些患者患有慢性功能受限的颈痛和上肢痛,继发于颈椎术后综合征。

临床试验

NCT01071369。

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