Acupuncture as adjunctive therapy for acute renal colic caused by urinary calculi: study protocol for a randomized controlled trial.

Abstract

BACKGROUND:

Acute renal colic caused by urinary calculi (ARCUC) has a considerable impact on the quality of life. Acupuncture might be a potential treatment option. However, the evidence is limited. We will conduct this trial to evaluate the efficacy and safety of acupuncture as adjunctive treatment to diclofenac for ARCUC.

METHODS/DESIGN:

A total of 80 eligible patients who are diagnosed with urinary stone renal colic will be randomly allocated to the acupuncture group or the sham acupuncture group. Each patient will receive 1 session of acupuncture or sham acupuncture. The primary outcome will be the response rate of patients achieving a reduction of > 50% on visual analog score (VAS) from baseline to 10 min after treatment. Secondary outcomes will include the VAS, remedial analgesia, re-visit and admission rate, blinding assessment, credibility and expectancy, and adverse event. All patients who receive randomization will be included in the intent-to-treat analysis.

DISCUSSION:

The finding of this trial will provide evidence on the efficacy and safety of acupuncture for the treatment of ARCUC. The results of this study will be published in peer-reviewed journals.

TRIAL REGISTRATION:

ClinicalTrials.gov ChiCTR 1900025202 . Registered on August 16, 2019.

• Authors: Ying Cao, Jian-Feng Tu, Guang-Xia Shi, Li-Qiong Wang, Lian-Cheng Jia, Bo Li, Bao-Li Liu, Wei-Hai Yao, Xiao-Lu Pei, Zhi-Cheng Qu, Cun-Zhi Liu
• Journal: Trials (Trials) Vol. 22 Issue 1 Pg. 652 (Sep 25 2021) ISSN: 1745-6215 [Electronic] England
• PMID: 34563246 (Publication Type: Clinical Trial Protocol, Journal Article)
• Copyright: © 2021. The Author(s).

Topics

• Acupuncture Therapy (adverse effects)
• Humans
• Quality of Life
• Randomized Controlled Trials as Topic
• Renal Colic (diagnosis, etiology, therapy)
• Treatment Outcome
• Urinary Calculi