Ear Pressure Points Plus Pain Meds for Faster Kidney Stone Pain Relief

Not Applicable

Not yet recruiting

• Conditions: Renal Colic; Acupuncture, Ear
• Interventions: Drug: Non-Steroidal anti-inflammatory drugs (NSAIDS); Other: Auricular Acupoint Embedding; Other: Sham Acupoint Embedding

• Registration Number: NCT06978816
• Lead Sponsor: Gao Xiaofeng

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-27
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-12
• Last Update Submitted: 2025-05-12
• Study First Posted: 2025-05-18
• Last Update Posted: 2025-05-18
• Study Start: 2025-06-01
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

1. Age between 15 and 75 years (inclusive)
2. Diagnosis of urinary tract stones confirmed by CT or ultrasound
3. Visual Analog Scale (VAS) score ≥ 4 (indicating moderate to severe renal colic)
4. No severe cardiac, hepatic, or pulmonary dysfunction, and no coagulation disorders.
5. No psychiatric disorders

Exclusion Criteria

1. Use of any analgesic medication within the past 6 hours.
2. Allergy to NSAIDs, morphine, or anisodamine (scopolamine derivatives)
3. History of asthma, urticaria, congestive heart failure, acute ischemic heart disease, acute cerebrovascular disease, or increased intracranial pressure
4. Active peptic ulcer, pyloric obstruction, or intestinal obstruction
5. Severe adverse reactions to acupuncture in the past
6. Pregnancy or lactation
7. Unwillingness to sign informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Verum Auricular Acupoint Embedding Group	Non-Steroidal anti-inflammatory drugs (NSAIDS)	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.
Verum Auricular Acupoint Embedding Group	Auricular Acupoint Embedding	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.
Sham Auricular Acupoint Embedding Group	Non-Steroidal anti-inflammatory drugs (NSAIDS)	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
Sham Auricular Acupoint Embedding Group	Sham 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

Primary Outcome Measures

Name	Time	Method
Response rate of Visual Analog Scale (VAS) reduction	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)

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse reactions	At 0, 5, 10, 15, 20, 30, 45, and 60 minutes after intervention initiation	Adverse reactions refer to harmful effects caused by medical treatment, such as: nausea, rash, dizziness, abnormal liver function, etc.
Blood pressure	At 0, 5, 10, 15, 20, 30, 45, and 60 minutes after intervention initiation	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.
body temperature	At 0, 5, 10, 15, 20, 30, 45, and 60 minutes after intervention initiation	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).
Heart rate	At 0, 5, 10, 15, 20, 30, 45, and 60 minutes after intervention initiation	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.