RecruitingNot ApplicableNCT06978816

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

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


Sponsor

Gao Xiaofeng

Enrollment

116 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

  • 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 Criteria7

  • 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

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Interventions

DRUGNon-Steroidal anti-inflammatory drugs (NSAIDS)

Intravenous infusion of 50 mg dexketoprofen trometamol injection

OTHERAuricular Acupoint Embedding

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

OTHERSham Acupoint Embedding

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.


Locations(1)

shanghai Changhai Hospitai

Shanghai, Shanghai Municipality, China

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NCT06978816


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