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Clinical Trials/NCT06233643
NCT06233643Not yet recruitingNot Applicable

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 sites120 target enrollmentStarted: February 1, 2024Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
120
Primary Endpoint
Baseline characteristics of patients

Study Overview

Brief Summary

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.

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

The group received acupuncture combined with intradermal sterile water

Experimental

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

Intervention: 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.

Intervention: Phloroglucinol (Drug)

Outcomes

Primary Outcomes

Baseline characteristics of patients

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

  • side effects(in 120 minutes after treatment.)

Investigators

Sponsor
The Third Affiliated Hospital of Beijing University of Chinese Medicine
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jianghua Yang

Urologist of Third BUCM,MD

The Third Affiliated Hospital of Beijing University of Chinese Medicine

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