Health TrialsbyHealthPanel

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

ConditionsRenal ColicAcupuncture, Ear
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGao Xiaofeng

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Non-Steroidal anti-inflammatory drugs (NSAIDS)

    Drug

    Intravenous infusion of 50 mg dexketoprofen trometamol injection

  • Auricular Acupoint Embedding

    Other intervention

    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 Embedding

    Other intervention

    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.

Treatment groups

116 Participants
are divided into 2 treatment groups
Group A: Verum Auricular Acupoint Embedding GroupExperimental treatment 2 interventions
Group B: Sham Auricular Acupoint Embedding GroupSham comparator 2 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gao Xiaofeng

Lead sponsor

Changhai Hospital

Sponsor institution

Source ClinicalTrials.gov
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