The Efficiency of Acupuncture Combined Intradermal Sterile Water Application in Acute Renal Colic

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Renal Colic
• Intervention / Treatment: Combination product: Acupuncture Combined Intradermal Sterile Water; Drug: Phloroglucinol

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 Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The group received acupuncture combined with intradermal sterile water; These acute renal colic patients who will received acupuncture combined with intradermal sterile water	Combination product: Acupuncture Combined Intradermal Sterile Water; Acupuncture was applied to a seated patient using the urinary bladder meridian points and combianed Intradermal Sterile Water in costovertebral area where the patient's pain was located (Sterile water of 0.5 ml was injected as intradermal into 4 points at a depth of 1-3 mm to form papules)
Active Comparator: The group received intramuscular inject phloroglucinol; These acute renal colic patients who will received intramuscular inject phloroglucinol.	Drug: Phloroglucinol; The active comparators will be treated with 40 mg of Phloroglucinol in the form of a single intramuscular injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline characteristics of patients	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)	before treatment
primary outcome	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.	10, 30, 60, and 120 minutes after treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
side effects	Document any side effects that occur after the intervention	in 120 minutes after treatment.

Collaborators and Investigators

• Sponsor: The Third Affiliated Hospital of Beijing University of Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): February 1, 2024
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: January 13, 2024
• First Submitted That Met QC Criteria: January 27, 2024
• First Posted (Estimated): January 31, 2024

Study Record Updates

• Last Update Posted (Estimated): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 27, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Acupuncture; NSAIDS; Intradermal Sterile Water
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Infant, Newborn, Diseases; Urogenital Diseases; Genital Diseases; Renal Colic; Infertility; Colic
• Other Study ID Numbers: ThirdBUCM

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No