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与高容量局部麻醉剂联合皮质类固醇肩峰下注射相比,低容量局部麻醉剂联合皮质类固醇肩峰下注射治疗肩袖撞击综合征的短期疗效:一项随机对照非劣效性试验

Short-term outcomes of subacromial injection of combined corticosteroid with low-volume compared to high-volume local anesthetic for rotator cuff impingement syndrome: a randomized controlled non-inferiority trial.

作者信息

Boonard Manusak, Sumanont Sermsak, Arirachakaran Alisara, Apiwatanakul Punyawat, Boonrod Artit, Kanchanatawan Wichan, Kongtharvonskul Jatupon

机构信息

Orthopedics Center, Bangkok Hospital Udon, Udon Thani, Thailand.

Department of Orthopedic, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.

出版信息

Eur J Orthop Surg Traumatol. 2018 Aug;28(6):1079-1087. doi: 10.1007/s00590-018-2149-3. Epub 2018 Feb 8.

DOI:10.1007/s00590-018-2149-3
PMID:29423865
Abstract

BACKGROUND

In symptomatic tendinosis, a corticosteroid injection into the subacromial space is a palliative treatment option. This study compares high volumes (10 cc) of local anesthetic (LA) combined with triamcinolone acetate (TA) with low volumes (4 cc) of LA combined with TA to see whether the latter would provide similar pain, function and complication outcomes for subacromial injections in patients with impingement syndrome.

MATERIALS AND METHODS

This single-center, randomized, single-blind, non-inferiority trial included patients with shoulder pain and positive multiple clinical tests supporting the diagnosis of impingement syndrome. All 52 patients received subacromial injections, with either high-volume corticosteroid injections (HCI) (10 mL total volume of 1% lidocaine plus 40 mg TA) in 26 patients or low-volume corticosteroid injections (LCI) (4 mL total volume of 1% lidocaine plus 40 mg TA) in 26 patients. The demographic data were reported with the primary outcomes being VAS and WORC scores measured at 30 min, then 2 and 8 weeks after receiving the injections. A non-inferiority margin of 13% was assumed.

RESULTS

Fifty-two patients (26 patients per group) were enrolled in the HCI and LCI. Mean VAS and WORC scores of HCI and LCI at baseline were 6.96, 33.85, 6.81 and 36.54, respectively. The mean VAS measured at 30 min, 2 and 8 weeks was 4.04, 2.08 and 1.20, respectively, in HCI group and 2.65, 1.95 and 1.26, respectively, in LCI group. The mean WORC at 2 and 8 weeks was 67.46 and 81.74, respectively, in HCI group and 65.42 and 80.12 in LCI group. These were not statistically significantly different (P > 0.05 in all).

CONCLUSION

Corticosteroid injections can be used in the treatment of subacromial impingement syndrome. Low-volume (4 cc) corticosteroid injections have non-inferior pain results for VAS score when compared with high-volume (10 cc) corticosteroid injections. CLINICALTRIALS.GOV: NCT03120923.

LEVEL OF EVIDENCE

Level I.

摘要

背景

在有症状的肌腱病中,向肩峰下间隙注射皮质类固醇是一种姑息治疗选择。本研究比较高容量(10毫升)局部麻醉剂(LA)联合醋酸曲安奈德(TA)与低容量(4毫升)LA联合TA,以观察后者对于撞击综合征患者肩峰下注射是否能提供相似的疼痛、功能及并发症结果。

材料与方法

这项单中心、随机、单盲、非劣效性试验纳入了有肩部疼痛且多项临床检查阳性支持撞击综合征诊断的患者。所有52例患者均接受肩峰下注射,其中26例患者接受高容量皮质类固醇注射(HCI)(1%利多卡因10毫升加40毫克TA的总体积),26例患者接受低容量皮质类固醇注射(LCI)(1%利多卡因4毫升加40毫克TA的总体积)。报告了人口统计学数据,主要结局为注射后30分钟、2周和8周时测量的视觉模拟评分(VAS)和美国肩肘外科医师学会(WORC)评分。假定非劣效性界值为13%。

结果

HCI组和LCI组各纳入52例患者(每组26例)。HCI组和LCI组基线时的平均VAS和WORC评分分别为6.96、33.85、6.81和36.54。HCI组在30分钟、2周和8周时测量的平均VAS分别为4.04、2.08和1.20,LCI组分别为2.65、1.95和1.26。HCI组在2周和8周时的平均WORC分别为67.46和81.74,LCI组分别为65.42和80.12。这些差异无统计学意义(所有P>0.05)。

结论

皮质类固醇注射可用于治疗肩峰下撞击综合征。与高容量(10毫升)皮质类固醇注射相比,低容量(4毫升)皮质类固醇注射在VAS评分方面的疼痛结果非劣效。临床试验注册编号:NCT03120923。

证据级别

I级。

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