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

NCT06978816 | Recruiting DMC

• 1 other identifier: CHC2025-130
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Colic; Acupuncture, Ear

Keywords

Kidney Calculi; Renal Colic; acupuncture, ear

Outcome Measures

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)

  At 0, 5, 10, 15, 20, 30, 45, and 60 minutes after intervention initiation

Secondary Outcomes (5)

• Recurrence rate of pain within 48 hours

  Within 48 hours after the completion of this emergency treatment

• Incidence of adverse reactions

  At 0, 5, 10, 15, 20, 30, 45, and 60 minutes after intervention initiation

• body temperature

  At 0, 5, 10, 15, 20, 30, 45, and 60 minutes after intervention initiation

• Blood pressure

  At 0, 5, 10, 15, 20, 30, 45, and 60 minutes after intervention initiation

• Heart rate

  At 0, 5, 10, 15, 20, 30, 45, and 60 minutes after intervention initiation

Study Arms (2)

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.

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

Drug: Non-Steroidal anti-inflammatory drugs (NSAIDS); Other: Sham Acupoint Embedding

Interventions

Non-Steroidal anti-inflammatory drugs (NSAIDS) DRUG

Intravenous infusion of 50 mg dexketoprofen trometamol injection

Sham Auricular Acupoint Embedding Group; Verum Auricular Acupoint Embedding Group

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

Also known as: acupuncture, ear

Verum Auricular Acupoint Embedding Group

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.

Sham Auricular Acupoint Embedding Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gao Xiaofeng: lead

Study Sites (1)

shanghai Changhai Hospitai

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

MeSH Terms

Conditions

Renal Colic; Kidney Calculi

Interventions

Anti-Inflammatory Agents, Non-Steroidal; Acupuncture, Ear

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents; Acupuncture Therapy; Complementary Therapies; Therapeutics; Auriculotherapy

Central Study Contacts

Bowen Yu, bachelor

CONTACT

+8613125430609; yubowen19960609@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Attending Urologist, Changhai Hospital

Study Record Dates

• First Submitted: April 27, 2025
• First Posted: May 18, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

CN (1)