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

NCT06233643 | Unknown

• 1 other identifier: ThirdBUCM
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Renal Colic

Keywords

Acupuncture; Intradermal Sterile Water; NSAIDS

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• side effects

  in 120 minutes after treatment.

Study Arms (2)

The group received acupuncture combined with intradermal sterile water

EXPERIMENTAL

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

Combination Product: Acupuncture Combined Intradermal Sterile Water

The group received intramuscular inject phloroglucinol

ACTIVE COMPARATOR

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

Drug: Phloroglucinol

Interventions

Phloroglucinol DRUG

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

The group received intramuscular inject phloroglucinol

Acupuncture Combined Intradermal Sterile Water COMBINATION_PRODUCT

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)

The group received acupuncture combined with intradermal sterile water

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

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

MeSH Terms

Conditions

Renal Colic

Interventions

Phloroglucinol

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Urologist of Third BUCM,MD

Study Record Dates

• First Submitted: January 13, 2024
• First Posted: January 31, 2024
• Study Start: February 1, 2024
• Primary Completion: February 1, 2024
• Study Completion: January 31, 2025
• Last Updated: January 31, 2024

Record last verified: 2024-01