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NCT Number: NCT06978816

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

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.

Recruiting

Interested in participating?

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Key information

Conditions

Renal Colic Acupuncture, Ear Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Neurologic Manifestations Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

shanghai Changhai Hospitai

Shanghai, Shanghai Municipality, 200433, China

Location status: Recruiting

Location contact

Bowen Yu Bowen Yu

CONTACT

[email protected]

86+13125430609

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Non-Steroidal anti-inflammatory drugs (NSAIDS)

Drug

Intravenous infusion of 50 mg dexketoprofen trometamol injection

Auricular Acupoint Embedding

Other

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

Other names: acupuncture, ear

Sham Acupoint Embedding

Other

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Recurrence rate of pain within 48 hours

    Time frame: Within 48 hours after the completion of this emergency treatment

    "Recurrence" is defined as revisiting the emergency department due to renal colic.

  2. Incidence of adverse reactions

    Time frame: 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.

  3. body temperature

    Time frame: 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).

  4. Blood pressure

    Time frame: 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.

  5. Heart rate

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bowen Yu, bachelor

CONTACT

[email protected]

+8613125430609 ext. +8613817275828

Sponsors and collaborators

Lead sponsor

Gao Xiaofeng

Other

Registry information

Official study title

Auricular Acupoint Embedding as Adjunctive Therapy to NSAIDs for Accelerated Relief of Renal Colic in Urolithiasis: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 18, 2025
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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