Acupuncture, Ear, Renal Colic
Conditions
Keywords
Kidney Calculi, Renal Colic, acupuncture, ear
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.
Interventions
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.
Sponsors
Gao Xiaofeng
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 15 and 75 years (inclusive) 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
1. Use of any analgesic medication within the past 6 hours. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response rate of Visual Analog Scale (VAS) reduction | 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
| Measure | Time frame | Description |
|---|---|---|
| Recurrence rate of pain within 48 hours | Within 48 hours after the completion of this emergency treatment | "Recurrence" is defined as revisiting the emergency department due to renal colic. |
| Incidence of adverse reactions | 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. |
| body temperature | 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). |
| Blood pressure | 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. |
| Heart rate | 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. |
Countries
China
Contacts
CONTACTBowen Yu, bachelor
Outcome results
None listed