Renal ColicNCT06978816
Ear Pressure Points Plus Pain Meds for Faster Kidney Stone Pain Relief
A study testing Non-Steroidal anti-inflammatory drugs (NSAIDS) and Auricular Acupoint Embedding in people with Renal Colic and Acupuncture, Ear, run by Gao Xiaofeng at 1 site in China.
Trial summary
Title: Can Ear Acupressure Help Relieve Kidney Stone Pain Faster When Combined with Painkillers? Purpose: This study tests whether adding ear acupressure to standard painkillers (NSAIDs) helps adults with kidney stone pain feel better faster. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Renal Colic, Acupuncture, Ear
- What is being tested?
- Non-Steroidal anti-inflammatory drugs (NSAIDS) and Auricular Acupoint Embedding
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 116 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 15 and 75 years (inclusive)
- Diagnosis of urinary tract stones confirmed by CT or ultrasound
- Visual Analog Scale (VAS) score ≥ 4 (indicating moderate to severe renal colic)
- No severe cardiac, hepatic, or pulmonary dysfunction, and no coagulation disorders.
- No psychiatric disorders
Who cannot join
- Use of any analgesic medication within the past 6 hours.
- Allergy to NSAIDs, morphine, or anisodamine (scopolamine derivatives)
- History of asthma, urticaria, congestive heart failure, acute ischemic heart disease, acute cerebrovascular disease, or increased intracranial pressure
- Active peptic ulcer, pyloric obstruction, or intestinal obstruction
- Severe adverse reactions to acupuncture in the past
- Pregnancy or lactation
- Unwillingness to sign informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
shanghai Changhai Hospitai
Shanghai, Shanghai Municipality, 200433
Bowen Yu Bowen Yu, 86+13125430609, yubowen19960609@qq.com
About this study
Official title: Auricular Acupoint Embedding as Adjunctive Therapy to NSAIDs for Accelerated Relief of Renal Colic in Urolithiasis: A Randomized Controlled Trial
Title: Can Ear Acupressure Help Relieve Kidney Stone Pain Faster When Combined with Painkillers?
Purpose:
Read more
This study tests whether adding ear acupressure to standard painkillers (NSAIDs) helps adults with kidney stone pain feel better faster. The investigators also want to know if this combination causes any side effects.
Key Questions:
Does ear acupressure + NSAIDs reduce pain more quickly than NSAIDs alone? Are there any safety concerns with this treatment? How does real ear acupressure compare to a fake (placebo) procedure? Who Can Join? Adults aged 18-75 Experiencing moderate-to-severe kidney stone pain (confirmed by CT or ultrasound) No recent painkiller use or allergies to NSAIDs
What Participants Will Do:
Receive in the emergency room:
Real treatment: Tiny needles placed on 3 ear points + NSAIDs (ketorolac injection) OR Placebo treatment: Fake tape on ear points + NSAIDs (same injection) Rate their pain on a 0-10 scale over 60 minutes. Have their heart rate and blood pressure checked.
Study Details:
Duration: Single ER visit (no long-term follow-up) Participants Needed: 116 Safety: Rescue pain medication (like morphine) is available if needed.
Why This Matters:
Kidney stones cause severe pain, and current painkillers may not work fast enough. Ear acupressure is a low-risk method from traditional Chinese medicine that could provide quicker relief.
Ethics:
Approved by Changhai Hospital's Ethics Committee. Participants can leave the study anytime.
- Conditions
- Renal Colic, Acupuncture, Ear
- Being tested
- Non-Steroidal anti-inflammatory drugs (NSAIDS), Auricular Acupoint Embedding, Sham Acupoint Embedding
- Keywords
- Kidney Calculi, Renal Colic, acupuncture, ear
- Medical subject headings
- Renal Colic, Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Steroidal anti-inflammatory drugs (NSAIDS)Drug
Intravenous infusion of 50 mg dexketoprofen trometamol injection
Auricular Acupoint EmbeddingOther
Also called acupuncture, ear
Concurrently with the intravenous infusion of dexketoprofen trometamol, verum auricular acupoint embedding was performed using disposable sterile press needles at three ipsilateral ear points: thalamus (MA-AT), kidney (MA-SC), and shenmen (MA-TF1), with needle retention for 60 minutes
Sham Acupoint EmbeddingOther
Concurrently with the intravenous infusion of dexketoprofen trometamol, sham auricular stimulation was administered using non-penetrating adhesive patches applied to three ipsilateral ear points: thalamus (MA-AT), kidney (MA-SC), and shenmen (MA-TF1), maintaining the application for 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Verum Auricular Acupoint Embedding Group | Experimental | In the experimental group, patients received verum auricular acupoint embedding using disposable sterile press needles (0.22×0.5 mm) at three ipsilateral ear points - thalamus (MA-AT), kidney (MA-SC), and shenmen (MA-TF1) - combined with intravenous infusion of 50 mg dexketoprofen trometamol (a non-steroidal anti-inflammatory drug) as adjuvant therapy. Receives: Drug: Non-Steroidal anti-inflammatory drugs (NSAIDS); Other: Auricular Acupoint Embedding |
| Sham Auricular Acupoint Embedding Group | Sham comparator | In the control group, participants received sham auricular stimulation using non-penetrating adhesive patches applied to the same ipsilateral ear points (thalamus [MA-AT], kidney [MA-SC], and shenmen [MA-TF1]) without needle insertion, combined with identical intravenous administration of 50 mg dexketoprofen trometamol (NSAID) as per the experimental protocol Receives: Drug: Non-Steroidal anti-inflammatory drugs (NSAIDS); Other: Sham Acupoint Embedding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate of Visual Analog Scale (VAS) reduction
The Visual Analog Scale (VAS) is a validated, subjective measurement tool widely used in clinical research to assess symptom intensity (e.g., pain, nausea). It consists of a 100-mm horizontal or vertical line anchored by two extremes: "no symptom" (0 mm) and "worst imaginable symptom" (100 mm). Participants mark their current level of intensity, with the score determined by measuring the distance from the "no symptom" endpoint.Response rate of Visual Analog Scale (VAS) reduction (defined as ≥50% decrease from baseline)
Measured: At 0, 5, 10, 15, 20, 30, 45, and 60 minutes after intervention initiation
Secondary outcomes (5)
Recurrence rate of pain within 48 hours
"Recurrence" is defined as revisiting the emergency department due to renal colic.
Measured: Within 48 hours after the completion of this emergency treatment
Incidence of adverse reactions
Adverse reactions refer to harmful effects caused by medical treatment, such as: nausea, rash, dizziness, abnormal liver function, etc.
Measured: At 0, 5, 10, 15, 20, 30, 45, and 60 minutes after intervention initiation
body temperature
Body temperature refers to the internal temperature of the human body and is a key indicator for maintaining normal physiological functions and metabolic activities. It is typically measured in degrees Celsius (°C) or Fahrenheit (°F), and its stable range is precisely regulated by the hypothalamus (the body's thermoregulatory center).
Measured: At 0, 5, 10, 15, 20, 30, 45, and 60 minutes after intervention initiation
Blood pressure
Blood pressure refers to the force exerted by circulating blood against the walls of blood vessels, primarily the arteries. It is conventionally measured in mmHg. It is a vital physiological parameter that ensures adequate blood flow to organs and tissues.
Measured: At 0, 5, 10, 15, 20, 30, 45, and 60 minutes after intervention initiation
Heart rate
Heart rate refers to the number of heartbeats per minute (bpm), reflecting the cardiac cycle frequency. It is a vital cardiovascular parameter indicating circulatory system function.
Measured: At 0, 5, 10, 15, 20, 30, 45, and 60 minutes after intervention initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start1 Jun 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Dec 2026 (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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gao Xiaofeng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gao Xiaofeng, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06978816
- Sponsor's protocol ID
- CHC2025-130
- Status last verified
- Mar 2026
- First submitted
- 27 Apr 2025
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auricular Acupoint Embedding as Adjunctive Therapy to NSAIDs for Accelerated Relief of Renal Colic in Urolithiasis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06978816
- Acronym / sponsor ID
- CHC2025-130
- Conditions
- Renal Colic, Acupuncture, Ear
- Keywords
- Kidney Calculi, Renal Colic, acupuncture, ear
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Gao XiaofengUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 18 May 2025 (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.
Title: Can Ear Acupressure Help Relieve Kidney Stone Pain Faster When Combined with Painkillers?
Purpose:
This study tests whether adding ear acupressure to standard painkillers (NSAIDs) helps adults with kidney stone pain feel better faster. The investigators also want to know if this combination causes any side effects.
Key Questions:
Does ear acupressure + NSAIDs reduce pain more quickly than NSAIDs alone? Are there any safety concerns with this treatment? How does real ear acupressure compare to a fake (placebo) procedure? Who Can Join? Adults aged 18-75 Experiencing moderate-to-severe kidney stone pain (confirmed by CT or ultrasound) No recent painkiller use or allergies to NSAIDs
What Participants Will Do:
Receive in the emergency room:
Real treatment: Tiny needles placed on 3 ear points + NSAIDs (ketorolac injection) OR Placebo treatment: Fake tape on ear points + NSAIDs (same injection) Rate their pain on a 0-10 scale over 60 minutes. Have their heart rate and blood pressure checked.
Study Details:
Duration: Single ER visit (no long-term follow-up) Participants Needed: 116 Safety: Rescue pain medication (like morphine) is available if needed.
Why This Matters:
Kidney stones cause severe pain, and current painkillers may not work fast enough. Ear acupressure is a low-risk method from traditional Chinese medicine that could provide quicker relief.
Ethics:
Approved by Changhai Hospital's Ethics Committee. Participants can leave the study anytime.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum Auricular Acupoint Embedding Group | Experimental | Drug: Non-Steroidal anti-inflammatory drugs (NSAIDS), Other: Auricular Acupoint EmbeddingIn the experimental group, patients received verum auricular acupoint embedding using disposable sterile press needles (0.22×0.5 mm) at three ipsilateral ear points - thalamus (MA-AT), kidney (MA-SC), and shenmen (MA-TF1) - combined with intravenous infusion of 50 mg dexketoprofen trometamol (a non-steroidal anti-inflammatory drug) as adjuvant therapy. |
| Sham Auricular Acupoint Embedding Group | Sham comparator | Drug: Non-Steroidal anti-inflammatory drugs (NSAIDS), Other: Sham Acupoint EmbeddingIn the control group, participants received sham auricular stimulation using non-penetrating adhesive patches applied to the same ipsilateral ear points (thalamus [MA-AT], kidney [MA-SC], and shenmen [MA-TF1]) without needle insertion, combined with identical intravenous administration of 50 mg dexketoprofen trometamol (NSAID) as per the experimental protocol |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 15 and 75 years (inclusive)
- Diagnosis of urinary tract stones confirmed by CT or ultrasound
- Visual Analog Scale (VAS) score ≥ 4 (indicating moderate to severe renal colic)
- No severe cardiac, hepatic, or pulmonary dysfunction, and no coagulation disorders.
- No psychiatric disorders
Key exclusion criteria (7 listed)
- Use of any analgesic medication within the past 6 hours.
- Allergy to NSAIDs, morphine, or anisodamine (scopolamine derivatives)
- History of asthma, urticaria, congestive heart failure, acute ischemic heart disease, acute cerebrovascular disease, or increased intracranial pressure
- Active peptic ulcer, pyloric obstruction, or intestinal obstruction
- Severe adverse reactions to acupuncture in the past
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 |
|---|---|---|
| Non-Steroidal anti-inflammatory drugs (NSAIDS)Intravenous infusion of 50 mg dexketoprofen trometamol injection | Drug | Sham Auricular Acupoint Embedding Group, Verum Auricular Acupoint Embedding Group |
| Auricular Acupoint EmbeddingAlso: acupuncture, earConcurrently with the intravenous infusion of dexketoprofen trometamol, verum auricular acupoint embedding was performed using disposable sterile press needles at three ipsilateral ear points: thalamus (MA-AT), kidney (MA-SC), and shenmen (MA-TF1), with needle retention for 60 minutes | Other | Verum Auricular Acupoint Embedding Group |
| Sham Acupoint EmbeddingConcurrently with the intravenous infusion of dexketoprofen trometamol, sham auricular stimulation was administered using non-penetrating adhesive patches applied to three ipsilateral ear points: thalamus (MA-AT), kidney (MA-SC), and shenmen (MA-TF1), maintaining the application for 60 minutes. | Other | Sham Auricular Acupoint Embedding Group |
Primary outcome
Response rate of Visual Analog Scale (VAS) reduction
Time frame: At 0, 5, 10, 15, 20, 30, 45, and 60 minutes after intervention initiation
The Visual Analog Scale (VAS) is a validated, subjective measurement tool widely used in clinical research to assess symptom intensity (e.g., pain, nausea). It consists of a 100-mm horizontal or vertical line anchored by two extremes: "no symptom" (0 mm) and "worst imaginable symptom" (100 mm). Participants mark their current level of intensity, with the score determined by measuring the distance from the "no symptom" endpoint.Response rate of Visual Analog Scale (VAS) reduction (defined as ≥50% decrease from baseline)
5 secondary outcomes
Recurrence rate of pain within 48 hours
Time frame: Within 48 hours after the completion of this emergency treatment
Incidence of adverse reactions
Time frame: At 0, 5, 10, 15, 20, 30, 45, and 60 minutes after intervention initiation
body temperature
Time frame: At 0, 5, 10, 15, 20, 30, 45, and 60 minutes after intervention initiation
Blood pressure
Time frame: At 0, 5, 10, 15, 20, 30, 45, and 60 minutes after intervention initiation
Heart rate
Time frame: At 0, 5, 10, 15, 20, 30, 45, and 60 minutes after intervention initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Steroidal anti-inflammatory drugs (NSAIDS) and Auricular Acupoint Embedding in people with Renal Colic and Acupuncture, Ear, run by Gao Xiaofeng at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. 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: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bowen Yu, bachelor (+8613125430609 ext. +8613817275828, yubowen19960609@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate of Visual Analog Scale (VAS) reduction (time frame: At 0, 5, 10, 15, 20, 30, 45, and 60 minutes after intervention initiation). 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 18 Mar 2026.