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临床试验/NCT06233643
NCT06233643尚未招募不适用

The Efficiency of Acupuncture Combined Intradermal Sterile Water Application in Acute Renal Colic: a Randomised Clinical Trial.

The Third Affiliated Hospital of Beijing University of Chinese Medicine0 个研究点目标入组 120 人开始时间: 2024年2月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
120
主要终点
Baseline characteristics of patients

研究概览

简要总结

The goal of this clinical trial is to compare the analgesic effect and tolerance profile of acupuncture combined with intradermal sterile water application versus intramuscular phloroglucinol in acute renal colic. In this study, we aimed primarily to test the efficacy of acupuncture combined with intradermal sterile water application as a rapid and effective treatment in severe renal colic.

Participants will randomly divided into two groups. The first group received only intramuscular phloroglucinol, the second group received acupuncture and intradermal sterile water.The visual analog scale (VAS,ranging from 0 for no pain to 10 for maximum imaginable pain) was used to assess pain intensity at baseline and at 10, 20, 30, 45,and 60 minutes following the start of the treatment protocol. Possible treatment side effects were also recorded.

详细描述

Inclusion criteria:We included all consecutive patients aged >18 years and presenting to our medical center with uncomplicated acute renal colic. Renal colic was considered if the patient description of pain included sudden onset of symptoms; unilateral flank or lower abdomen pain; irradiation to the back, side, or groin region; urination problems, including urinating difficultly and/or an abnormally dark or red urine; and the absence of other obvious conditions explaining patient symptoms.

Exclusion criteria:We excluded patients with complicated acute renal colic, defined by the presence of bilateral pain, fever, and/or decreased urine output (<500 mL per day). Patients presenting with posttraumatic pain, those taking anticoagulant medications or with coagulation problems, those with skin afflictions (infections, hematoma, dermatosis) that would impair the use of certain acupuncture points, those unable to assess the degree of pain using the VAS, those who had received analgesics in the 6 hours prior to enrollment, those refusing or unable to give written consent, and pregnant women were also excluded from this study. All participants read and signed the informed consent form of the study, which was approved by the ethics committee of the Third Affiliated Hospital of Beijing University of Chinese Medicine.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

The group received acupuncture combined with intradermal sterile water

Experimental

These acute renal colic patients who will received acupuncture combined with intradermal sterile water

干预措施: Acupuncture Combined Intradermal Sterile Water (Combination Product)

The group received intramuscular inject phloroglucinol

Active Comparator

These acute renal colic patients who will received intramuscular inject phloroglucinol.

干预措施: Phloroglucinol (Drug)

结局指标

主要结局

Baseline characteristics of patients

时间窗: before treatment

Baseline characteristics of patients between two groups concerning age (years), sex (male or female ), and baseline VAS score (ranging from 0 for no pain to 10 for maximum imaginable pain)

primary outcome

时间窗: 10, 30, 60, and 120 minutes after treatment.

Visual analogue scale (VAS, ranging from 0 for no pain to 10 for maximum imaginable pain) will be used to assess pain intensity after 10, 30, 60, and 120 minutes.

次要结局

  • side effects(in 120 minutes after treatment.)

研究者

发起方
The Third Affiliated Hospital of Beijing University of Chinese Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jianghua Yang

Urologist of Third BUCM,MD

The Third Affiliated Hospital of Beijing University of Chinese Medicine

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