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Идёт набор NCT06978816

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

Без фазы С лечением Renal Colic Acupuncture, Ear

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Non-Steroidal anti-inflammatory drugs (NSAIDS), Auricular Acupoint Embedding, Sham Acupoint Embedding.
Кому может быть актуально
Состояния в реестре: Renal Colic, Acupuncture, Ear. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

  • Препарат Non-Steroidal anti-inflammatory drugs (NSAIDS)
    Intravenous infusion of 50 mg dexketoprofen trometamol injection
  • Другое 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
  • Другое 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.

Первичные конечные точки

  • Response rate of Visual Analog Scale (VAS) reduction [Срок оценки: At 0, 5, 10, 15, 20, 30, 45, and 60 minutes after intervention initiation]
Вторичные конечные точки (5)
  • Recurrence rate of pain within 48 hours [Срок оценки: Within 48 hours after the completion of this emergency treatment]
  • Incidence of adverse reactions [Срок оценки: At 0, 5, 10, 15, 20, 30, 45, and 60 minutes after intervention initiation]
  • body temperature [Срок оценки: At 0, 5, 10, 15, 20, 30, 45, and 60 minutes after intervention initiation]
  • Blood pressure [Срок оценки: At 0, 5, 10, 15, 20, 30, 45, and 60 minutes after intervention initiation]
  • Heart rate [Срок оценки: At 0, 5, 10, 15, 20, 30, 45, and 60 minutes after intervention initiation]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • shanghai Changhai Hospitai — Шанхай

Идентификаторы

NCT: NCT06978816 · CHC2025-130

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗