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

T

The Third Affiliated Hospital of Beijing University of Chinese Medicine

Status

Not yet enrolling

Conditions

Renal Colic

Treatments

Drug: Phloroglucinol
Combination Product: Acupuncture Combined Intradermal Sterile Water

Study type

Interventional

Funder types

Other

Identifiers

NCT06233643
ThirdBUCM

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

120 participants in 2 patient groups

The group received acupuncture combined with intradermal sterile water
Experimental group
Description:
These acute renal colic patients who will received acupuncture combined with intradermal sterile water
Treatment:
Combination Product: Acupuncture Combined Intradermal Sterile Water
The group received intramuscular inject phloroglucinol
Active Comparator group
Description:
These acute renal colic patients who will received intramuscular inject phloroglucinol.
Treatment:
Drug: Phloroglucinol

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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