An interventional study of Non-Steroidal anti-inflammatory drugs (NSAIDS) and Auricular Acupoint Embedding in Renal Colic and Acupuncture, Ear, sponsored by Gao Xiaofeng. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-03-18.
Sponsored by Gao Xiaofeng · Not applicable, Interventional, and Treatment
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.
79 studies on the registry are indexed under Renal Colic; 10 are open to participants now.
This study's planned enrollment of 116 is close to the median of 118 across 60 interventional studies indexed under Renal Colic.
Browse Renal Colic studies →This is the only study on the registry with Gao Xiaofeng as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Non-Steroidal anti-inflammatory drugs (NSAIDS) · Other: Auricular Acupoint Embedding
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
Drug: Non-Steroidal anti-inflammatory drugs (NSAIDS) · Other: Sham Acupoint Embedding
Intravenous infusion of 50 mg dexketoprofen trometamol injection
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
Also known as: acupuncture, ear
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.
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)
Time frame: At 0, 5, 10, 15, 20, 30, 45, and 60 minutes after intervention initiation
Recurrence rate of pain within 48 hours
"Recurrence" is defined as revisiting the emergency department due to renal colic.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: At 0, 5, 10, 15, 20, 30, 45, and 60 minutes after intervention initiation
Plan to share: Undecided
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