Ear Pressure Points Plus Pain Meds for Faster Kidney Stone Pain Relief
NCT ID: NCT06978816
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
116 participants
INTERVENTIONAL
2025-12-01
2026-12-01
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Verum Auricular Acupoint Embedding Group
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.
Non-Steroidal anti-inflammatory drugs (NSAIDS)
Intravenous infusion of 50 mg dexketoprofen trometamol injection
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
Sham Auricular Acupoint Embedding Group
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
Non-Steroidal anti-inflammatory drugs (NSAIDS)
Intravenous infusion of 50 mg dexketoprofen trometamol injection
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.
Interventions
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Non-Steroidal anti-inflammatory drugs (NSAIDS)
Intravenous infusion of 50 mg dexketoprofen trometamol injection
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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of urinary tract stones confirmed by CT or ultrasound
3. Visual Analog Scale (VAS) score ≥ 4 (indicating moderate to severe renal colic)
4. No severe cardiac, hepatic, or pulmonary dysfunction, and no coagulation disorders.
5. No psychiatric disorders
Exclusion Criteria
2. Allergy to NSAIDs, morphine, or anisodamine (scopolamine derivatives)
3. History of asthma, urticaria, congestive heart failure, acute ischemic heart disease, acute cerebrovascular disease, or increased intracranial pressure
4. Active peptic ulcer, pyloric obstruction, or intestinal obstruction
5. Severe adverse reactions to acupuncture in the past
6. Pregnancy or lactation
7. Unwillingness to sign informed consent
18 Years
75 Years
ALL
No
Sponsors
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Gao Xiaofeng
OTHER
Responsible Party
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Gao Xiaofeng
Senior Attending Urologist, Changhai Hospital
Central Contacts
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Other Identifiers
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CHC2025-130
Identifier Type: -
Identifier Source: org_study_id