Renal ColicNCT06233643
The Efficiency of Acupuncture Combined Intradermal Sterile Water Application in Acute Renal Colic
A study testing Phloroglucinol and Acupuncture Combined Intradermal Sterile Water in people with Renal Colic, run by The Third Affiliated Hospital of Beijing University of Chinese Medicine.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Renal Colic
- What is being tested?
- Phloroglucinol and Acupuncture Combined Intradermal Sterile Water
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Renal Colic
- Being tested
- Phloroglucinol, Acupuncture Combined Intradermal Sterile Water
- Keywords
- Acupuncture, Intradermal Sterile Water, NSAIDS
- Medical subject headings
- Renal Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhloroglucinolDrug
The active comparators will be treated with 40 mg of Phloroglucinol in the form of a single intramuscular injection.
Acupuncture Combined Intradermal Sterile WaterCombination 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)
| Study group | Role | What they receive |
|---|---|---|
| The group received acupuncture combined with intradermal sterile water | Experimental | These acute renal colic patients who will received acupuncture combined with intradermal sterile water Receives: 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. Receives: Drug: Phloroglucinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 10, 30, 60, and 120 minutes after treatment.
Secondary outcomes (1)
side effects
Document any side effects that occur after the intervention
Measured: in 120 minutes after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start1 Feb 2024 (estimated)
- Primary completion1 Feb 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal ColicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Affiliated Hospital of Beijing University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianghua Yang, The Third Affiliated Hospital of Beijing University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06233643
- Sponsor's protocol ID
- ThirdBUCM
- Status last verified
- Jan 2024
- First submitted
- 13 Jan 2024
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficiency of Acupuncture Combined Intradermal Sterile Water Application in Acute Renal Colic: a Randomised Clinical Trial.
- ClinicalTrials.gov ID
- NCT06233643
- Acronym / sponsor ID
- ThirdBUCM
- Conditions
- Renal Colic
- Keywords
- Acupuncture, Intradermal Sterile Water, NSAIDS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The Third Affiliated Hospital of Beijing University of Chinese MedicineUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 31 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The group received acupuncture combined with intradermal sterile water | Experimental | Combination Product: Acupuncture Combined Intradermal Sterile WaterThese acute renal colic patients who will received acupuncture combined with intradermal sterile water |
| The group received intramuscular inject phloroglucinol | Active comparator | Drug: PhloroglucinolThese acute renal colic patients who will received intramuscular inject phloroglucinol. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhloroglucinolThe active comparators will be treated with 40 mg of Phloroglucinol in the form of a single intramuscular injection. | Drug | The group received intramuscular inject phloroglucinol |
| Acupuncture Combined Intradermal Sterile WaterAcupuncture 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) | Combination product | The group received acupuncture combined with intradermal sterile water |
Primary outcome
Baseline characteristics of patients
Time frame: before treatment
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)
primary outcome
Time frame: 10, 30, 60, and 120 minutes after treatment.
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.
1 secondary outcome
side effects
Time frame: in 120 minutes after treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
Related trials for Renal Colic
RecruitingPhase 3
Comparative Efficacy of IV Dexamethasone vs. Nebulized Terbutaline for Renal Colic Pain in the ED
Renal Colic
Not yet recruiting
Relief Efficacy of Lidocaine Versus Morphine for Acute Renal Colic in the Emergency Department
Renal Colic, Kidney Stones, Urolithiasis, Hypocitraturia
Recruiting
Ear Pressure Points Plus Pain Meds for Faster Kidney Stone Pain Relief
Renal Colic, Acupuncture, Ear
Active, not recruiting
Sterile Water Injection vs Morphine for Renal Colic
Renal Colic, Urolithiasis
Not yet recruitingPhase 4
Analgesic Efficacy of Transcutaneous Electrical Nerve Stimulation and Dexketoprofen in Renal Colic
Renal Colic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Phloroglucinol and Acupuncture Combined Intradermal Sterile Water in people with Renal Colic, run by The Third Affiliated Hospital of Beijing University of Chinese Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline characteristics of patients (time frame: before treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.