Ear Pressure Points Plus Pain Meds for Faster Kidney Stone Pain Relief
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non-Steroidal anti-inflammatory drugs (NSAIDS), Auricular Acupoint Embedding, Sham Acupoint Embedding.
- Who it may be relevant to
- Registry conditions: Renal Colic, Acupuncture, Ear. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Auricular Acupoint Embedding as Adjunctive Therapy to NSAIDs for Accelerated Relief of Renal Colic in Urolithiasis: A Randomized Controlled Trial
Overview
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.
Interventions
- Drug Non-Steroidal anti-inflammatory drugs (NSAIDS)
Intravenous infusion of 50 mg dexketoprofen trometamol injection - Other Auricular 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 - Other Sham 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.
Primary outcome measures
- Response rate of Visual Analog Scale (VAS) reduction [Time frame: At 0, 5, 10, 15, 20, 30, 45, and 60 minutes after intervention initiation]
Secondary outcome measures (5)
- Recurrence rate of pain within 48 hours [Time frame: Within 48 hours after the completion of this emergency treatment]
- Incidence of adverse reactions [Time frame: At 0, 5, 10, 15, 20, 30, 45, and 60 minutes after intervention initiation]
- body temperature [Time frame: At 0, 5, 10, 15, 20, 30, 45, and 60 minutes after intervention initiation]
- Blood pressure [Time frame: At 0, 5, 10, 15, 20, 30, 45, and 60 minutes after intervention initiation]
- Heart rate [Time frame: At 0, 5, 10, 15, 20, 30, 45, and 60 minutes after intervention initiation]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- shanghai Changhai Hospitai — Shanghai
Identifiers
NCT: NCT06978816 · CHC2025-130