Ignite Creation Date:
2024-05-06 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06233643
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-31
First Post:
2024-01-13
Brief Title:
The Efficiency of Acupuncture Combined Intradermal Sterile Water Application in Acute Renal Colic
Sponsor:
The Third Affiliated Hospital of Beijing University of Chinese Medicine
Organization:
The Third Affiliated Hospital of Beijing University of Chinese Medicine
Study Overview
Official Title:
The Efficiency of Acupuncture Combined Intradermal Sterile Water Application in Acute Renal Colic a Randomised Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 waterThe visual analog scale VASranging from 0 for no pain to 10 for maximum imaginable pain was used to assess pain intensity at baseline and at 10 20 30 45and 60 minutes following the start of the treatment protocol Possible treatment side effects were also recorded
Participants will randomly divided into two groups The first group received only intramuscular phloroglucinol the second group received acupuncture and intradermal sterile waterThe visual analog scale VASranging from 0 for no pain to 10 for maximum imaginable pain was used to assess pain intensity at baseline and at 10 20 30 45and 60 minutes following the start of the treatment protocol Possible treatment side effects were also recorded
Detailed Description:
Inclusion criteriaWe 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 andor an abnormally dark or red urine and the absence of other obvious conditions explaining patient symptoms
Exclusion criteriaWe excluded patients with complicated acute renal colic defined by the presence of bilateral pain fever andor 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
Exclusion criteriaWe excluded patients with complicated acute renal colic defined by the presence of bilateral pain fever andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None