The Effectiveness and Safety of Pharmacopuncture on Inpatients With Acute Knee Pain Caused by Traffic Accidents

Официальное название

The Effectiveness and Safety of Pharmacopuncture on Inpatients With Acute Knee Pain Caused by Traffic Accidents : A Pragmatic Randomized Controlled Pilot Trial

Обзор

The purpose of this study is to reveal the effectiveness and safety of knee herbal acupuncture for patients with acute knee joint pain caused by a traffic accident. It is a practical clinical study to confirm the comparative effectiveness by comparing the strategy of treating knee herbal acupuncture in parallel with the strategy of treating it with integrated oriental medicine treatment, which is an existing treatment method.

Вмешательства

• Процедура Knee Pharmacoacupuncture
  Physician choose the adequate type and dose of pharmacoacupuncture and needle type
• Процедура Oriental medicine integrated treatment
  Physician choose the integrated oriental medicine treatment other than herbal acupuncture.

Первичные конечные точки

• Knee pain numeric rating scale (NRS) [Срок оценки: through admission completion, an average of 1week, 2 weeks and 4 weeks after admission date]

Вторичные конечные точки (4)

• Range of motion (ROM) [Срок оценки: Enrollment date, Discharge date(On average, 1 week after admission)]
• Korean Western Ontario & McMaster, K-WOMAC [Срок оценки: Enrollment date, Discharge date(On average, 1 week after admission), 2 and 4 weeks after admission date]
• EuroQol-5 Dimension (EQ-5D-5L) [Срок оценки: Enrollment date, Discharge date(On average, 1 week after admission), 2 and 4 weeks after admission date]
• Patient Global Impression of Change (PGIC) [Срок оценки: Discharge date(On average, 1 week after admission), 2 and 4 weeks after admission date]

Критерии участия

Критерии включения

• When the NRS (Numeric Rating Scale) of knee pain caused by a traffic accident is 5 or higher.
• Patients hospitalized for traffic accident treatment.
• Patients with acute pain within 14 days of experiencing knee pain due to a traffic accident.
• Patients aged between 19 and 70 years old.
• participants who agree to participate in clinical research and provide written test subject consent.

Критерии исключения

• For patients diagnosed with a specific serious disease that may cause knee pain (acute fracture, dislocation, complete rupture of ligaments, etc.)
• If the cause of the pain is caused by a disease other than the knee (tumor, fibromyalgia, rheumatoid arthritis, gout, lumbar disc herniation, etc.)
• Cases where surgical intervention is required due to suspected acute fracture, dislocation, or ligament and cartilage damage
• If there is another acute disease (stroke, myocardial infarction, kidney disease, diabetic neuropathy, dementia, epilepsy, etc.) that may interfere with the treatment effect or interpretation of results
• Patients currently taking steroids, immunosuppressants, mental illness drugs, or other drugs that may affect their findings
• Inadequate or unsafe medication: hemorrhagic disease, anticoagulant therapy, severe diabetic patients with risk of infection
• Patients who have taken drugs that may affect pain, such as Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), or have received herbal acupuncture or physical therapy within the past week
• In the case of pregnant women and in the case of planning to become pregnant or nursing
• Patients within 3 months after knee surgery or if knee replacement surgery was performed
• If it has been less than 1 month since participants finished participating in another clinical study, or if participants are planning to participate in another clinical study during the study participation and follow-up period within 6 months from the date of selection
• If it is difficult to fill out the consent form for research participation
• In cases where it is difficult for other researchers to participate in clinical research

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

Простое слепое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• Daejeon Jaseng Hospital of Korean Medicine — Daejeon

Идентификаторы

NCT: NCT06931951 · JS-CT-2025-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗