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

Renal Colic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06233643
• Other study ID #: ThirdBUCM
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: January 31, 2025

Study information

• Verified date: January 2024
• Source: The Third Affiliated Hospital of Beijing University of Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: January 31, 2025
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colic
• Infertility
• Renal Colic

Intervention

Drug:
• Phloroglucinol
The active comparators will be treated with 40 mg of Phloroglucinol in the form of a single intramuscular injection.

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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The Third Affiliated Hospital of Beijing University of Chinese Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	side effects	Document any side effects that occur after the intervention	in 120 minutes after treatment.