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早期干预针刺对疑似尿路结石所致急性肾绞痛急诊科患者疼痛缓解的影响:一项随机临床试验的研究方案

Effect of Early-Intervention Acupuncture on Pain Relief Among Emergency Department Patients with Suspected Acute Renal Colic Due to Urinary Calculi: Study Protocol for a Randomized Clinical Trial.

作者信息

Wang Xiao, Cao Ying, Hu Jing, Jia Lian-Cheng, Li Bo, Liu Baoli, Yao Wei-Hai, Pei Xiao-Lu, Peng Wei, Wang Shuang, Liu Cun-Zhi, Tu Jian-Feng, Qu Zhi-Cheng

机构信息

School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, Beijing, People's Republic of China.

Emergency Department, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing, People's Republic of China.

出版信息

J Pain Res. 2024 Nov 19;17:3831-3839. doi: 10.2147/JPR.S475466. eCollection 2024.

Abstract

INTRODUCTION

Analgesia is often delayed for suspected acute renal colic due to urinary calculi (ARCUC) even in emergency department. Acupuncture has a rapid onset and is effective for analgesia, however, evidence about early-acupuncture for suspected ARCUC is limited. This trial aims to evaluate the efficacy of early-intervention acupuncture compared with sham acupuncture on pain relief among emergency department suspected ARCUC patients.

METHODS AND ANALYSIS

A total of 84 eligible patients who are suspected diagnosed with ARCUC will be randomly allocated to the acupuncture group or the sham acupuncture group. Each patient will receive 1 session of acupuncture or sham acupuncture before diagnostic imaging. The primary outcome will be the response rate at 10 min after needle manipulation, defined as the proportion of patients whose Numeric Rating Scale (NRS) score decrease by at least 50% from baseline. Secondary outcomes will include pain intensity assessed by NRS, further analgesia requirement, revisit rate, surgical intervention rate, satisfaction evaluation, and adverse events. The final diagnosis rate determined by radiography will be recorded and reported. All patients who receive randomization will be included in the intention-to-treat analysis.

CONCLUSION

This study's findings are anticipated to evaluate the analgesic effect of early-intervention acupuncture for acute renal colic in emergency department, which could be useful for moving the timing of analgesia forward and aligning pain management for acute renal colic more with the guidelines.

TRIAL REGISTRATION NUMBER

ChiCTR2100049069 (https://www.chictr.org.cn/showproj.html?proj=125338).

摘要

引言

即使在急诊科,对于疑似因尿路结石导致的急性肾绞痛(ARCUC)患者,镇痛往往也会延迟。针灸起效迅速且镇痛效果显著,然而,关于早期针灸治疗疑似ARCUC的证据有限。本试验旨在评估早期干预针灸与假针灸相比,对急诊科疑似ARCUC患者疼痛缓解的疗效。

方法与分析

总共84名疑似诊断为ARCUC的合格患者将被随机分配到针灸组或假针灸组。每位患者在进行诊断性成像之前接受1次针灸或假针灸治疗。主要结局将是针刺操作后10分钟的反应率,定义为数字评分量表(NRS)评分较基线至少降低50%的患者比例。次要结局将包括通过NRS评估的疼痛强度、进一步的镇痛需求、复诊率、手术干预率、满意度评估和不良事件。将记录并报告由影像学确定的最终诊断率。所有接受随机分组的患者将纳入意向性分析。

结论

本研究结果有望评估早期干预针灸对急诊科急性肾绞痛的镇痛效果,这可能有助于提前镇痛时机,并使急性肾绞痛的疼痛管理更符合指南。

试验注册号

ChiCTR2100049069(https://www.chictr.org.cn/showproj.html?proj=125338)

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d8e5/11586264/b137a7f6c541/JPR-17-3831-g0001.jpg

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