NCT06931951招募中不适用
The Effectiveness and Safety of Pharmacopuncture on Inpatients With Acute Knee Pain Caused by Traffic Accidents : A Pragmatic Randomized Controlled Pilot Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Knee pain numeric rating scale (NRS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Knee Pharmacoacupuncture group
Experimental
20 patients in the Knee Pharmacoacupuncture group
干预措施: Knee Pharmacoacupuncture (Procedure)
Oriental medicine integrated treatment group
Active Comparator
20 patients in the Oriental medicine integrated treatment group
干预措施: Oriental medicine integrated treatment (Procedure)
结局指标
主要结局
Knee pain numeric rating scale (NRS)
时间窗: through admission completion, an average of 1week, 2 weeks and 4 weeks after admission date
The intensity of knee pain will be assessed using the NRS. In the NRS, participants choose a number from 0 to 10 that best describes participant's comfort (0 being no pain and 10 being the most comfortable they can imagine).
次要结局
- Range of motion (ROM)(Enrollment date, Discharge date(On average, 1 week after admission))
- Korean Western Ontario & McMaster, K-WOMAC(Enrollment date, Discharge date(On average, 1 week after admission), 2 and 4 weeks after admission date)
- Patient Global Impression of Change (PGIC)(Discharge date(On average, 1 week after admission), 2 and 4 weeks after admission date)
- EuroQol-5 Dimension (EQ-5D-5L)(Enrollment date, Discharge date(On average, 1 week after admission), 2 and 4 weeks after admission date)
研究者
研究点 (1)
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