一项比较骶髂关节注射中上三分之一联合入路与中下三分之一联合入路的前瞻性随机非劣效性试验。

A Prospective Randomized Noninferiority Trial Comparing Upper and Lower One-Third Joint Approaches for Sacroiliac Joint Injections.

机构信息

Department of Anesthesiology and Pain Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.

Department of Anesthesiology and Pain Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea.

出版信息

Pain Physician. 2018 May;21(3):251-258.

PMID:29871369

Abstract

BACKGROUND

Sacroiliac intraarticular injection using the upper one-third joint technique is recommended for injections that are difficult with the lower one-third joint technique.

OBJECTIVE

To evaluate the success rate of intraarticular sacroiliac joint (SIJ) injections using the upper and lower one-third joint techniques.

STUDY DESIGN

Prospective randomized noninferiority study.

SETTING

An interventional pain-management practice in a university hospital.

METHODS

In this single-blind, noninferiority trial, 181 patients were randomly assigned to either the upper (group U, 90 patients) or lower (group L, 91 patients) one-third joint techniques. The primary end point was the rate of successful intraarticular injections (%), with a noninferiority margin of 10 percentage points. The secondary end points included numeric rating scale (NRS) pain scores before, during and after the procedure, procedure time, degree of contrast spread, and occurrence of intravascular uptake or complications.

RESULTS

The intraarticular injection rate was 93.3% (84 of 90 patients) in group U and 95.6% (87 of 91 patients) in group L (difference, 2.6 percentage points; 95% confidence interval, -8.9 to 4.4). This study found no significant between-group differences in the degree of contrast spread throughout the joint (88.1% with group U and 87.4% with group L, P = 0.883), intravascular incidence (11.1% and 9.9%, respectively; P = 0.789), rate of complications (1.1% and 1.1%, respectively; P = 1.000), inadvertent spread beyond the joint (12.2% and 19.8%, respectively; P = 0.201), or mean post-procedural NRS score for pain (2.24 ± 1.87 and 2.52 ± 1.97, respectively; P = 0.342). However, the mean procedure time (111.2 ± 72.7 and 77.8 ± 60.4 s, respectively; P = 0.001), and mean NRS score for pain during the procedure differed significantly between the groups (2.28 ± 1.45 and 1.77 ± 0.99, respectively; P = 0.006).

LIMITATIONS

This study was designed as a noninferiority study of successful intraarticular injection rates and did not evaluate long-term outcomes.

CONCLUSIONS

The upper one-third joint technique for performing SIJ injections was not inferior to the lower one-third joint technique in terms of the intraarticular injection success rate.

KEY WORDS

Fluoroscopy, low back pain, lower one-third joint technique, sacroiliac joint, sacroiliac joint injection, upper one-third joint technique.

摘要

背景

对于使用下三分之一关节技术难以进行的注射，建议使用骶髂关节关节内注射的上三分之一关节技术。

目的

评估使用上三分之一和下三分之一关节技术进行骶髂关节 (SIJ) 关节内注射的成功率。

研究设计

前瞻性随机非劣效性研究。

地点

大学医院的介入性疼痛管理实践。

方法

在这项单盲、非劣效性试验中，181 名患者被随机分配至上三分之一（组 U，90 名患者）或下三分之一（组 L，91 名患者）关节技术。主要终点是关节内注射成功率（%），非劣效性边界为 10 个百分点。次要终点包括治疗前、治疗中和治疗后数字评分量表 (NRS) 疼痛评分、手术时间、对比剂扩散程度以及血管内摄取或并发症的发生。

结果

组 U 的关节内注射率为 93.3%（90 名患者中的 84 名），组 L 的注射率为 95.6%（91 名患者中的 87 名）（差异为 2.6 个百分点；95%置信区间为 -8.9 至 4.4）。本研究未发现两组间关节内对比剂扩散程度（组 U 为 88.1%，组 L 为 87.4%，P = 0.883）、血管内发生率（分别为 11.1%和 9.9%，P = 0.789）、并发症发生率（分别为 1.1%和 1.1%，P = 1.000）、关节外意外扩散率（分别为 12.2%和 19.8%，P = 0.201）或治疗后平均 NRS 疼痛评分（分别为 2.24 ± 1.87 和 2.52 ± 1.97，P = 0.342）有显著差异。然而，两组之间的平均手术时间（分别为 111.2 ± 72.7 和 77.8 ± 60.4 秒，P = 0.001）和治疗过程中的平均 NRS 疼痛评分差异显著（分别为 2.28 ± 1.45 和 1.77 ± 0.99，P = 0.006）。