The Efficacy and Safety of Chuna Manual Treatment for Patients With Primary Dysmenorrhea: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Peak dysmenorrhea NRS during menstrual period
研究概览
简要总结
This study is a randomized controlled trial that compares 30 patients with primary dysmenorrhea by assigning them in a 1:1 ratio between patients treated with a Chuna therapy strategy and patients treated with a strategy using physical therapy. The purpose of the study is to confirm the comparative effectiveness of Chuna therapy and physical therapy.
详细描述
Menstrual pain is known to be caused by increased tension in the uterine muscles and irregular contractions, and is experienced by 50% of women who menstruate. However, most people control pain with NSAIDs or hormones. Among non-pharmacological treatments, manual therapy is known to control menstrual pain by influencing pain perception and pain-related serological factors. Previous research results have shown that manual therapy using sacroiliac joint correction and high-speed, low-amplitude thrust techniques is effective for menstrual pain. However, there is still no randomized controlled study limited to Chuna therapy. Therefore, the investigators would like to conduct a randomized clinical study to determine the effectiveness and safety of Chuna therapy for primary dysmenorrhea.
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
- 14 Years 至 49 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients whose menstrual pain is NRS 5 or higher during the last 3 months due to primary dysmenorrhea
- •Patients who are between 14 and 49 years of age
- •Patients whose cycle has been regular between 21 and 40 days for the past 3 months
- •Patients who agree to participate in clinical research and provide written test subject consent
排除标准
- •Patients whose cause of menstrual pain is determined to be an organic problem (uterine fibroids, adenomyosis, endometriosis, etc.) rather than a primary cause.
- •Patients who have taken oral contraceptives or other hormonal therapy within the past 3 months.
- •Patients diagnosed with other chronic diseases (stroke, myocardial infarction, kidney disease, diabetic neuropathy, dementia, epilepsy, etc.) that may interfere with the treatment effect or interpretation of results.
- •Patients who are currently taking steroids, immunosuppressants, drugs for mental illness, or other drugs that may affect the results of the study.
- •Patients for whom manual therapy is inappropriate or unsafe: history of lumbar fusion or pelvic girdle surgery, spinal fracture, or severe instability.
- •Pregnant women, those planning to become pregnant within 6 months, and those planning to take hormones such as oral contraceptives.
- •Patients who finished participating in another clinical study less than 1 month ago, or who plan to participate in another clinical study during the study participation and follow-up period within 6 months from the date of selection.
- •Patients who find it difficult to fill out the consent form for research participation.
- •Other cases where participation in clinical research is deemed difficult by the researcher.
结局指标
主要结局
Peak dysmenorrhea NRS during menstrual period
时间窗: Screening day(Cycle -1), At the first visit of Cycle 1, 2, 3, 5 (each cycle is 28 days)
The maximum pain intensity during menstruation will be assessed using the NRS. In the NRS, patients choose a number from 0 to 10 that best represents their current level of discomfort (0 being no pain and 10 being the worst pain imaginable).
次要结局
- Positive and Negative Affect Schedule, PANAS(At the first visit of Cycle 1, 2, 3, 5 (each cycle is 28 days))
- EuroQol-5 Dimension, EQ-5D-5L(At the first visit of Cycle 1, 2, 3, 5 (each cycle is 28 days))
- EuroQol Visual Analogue Scale, EQ-VAS(At the first visit of Cycle 1, 2, 3, 5 (each cycle is 28 days))
- Modified pain scale(At the first visit of Cycle 1, 2, 3, 5 (each cycle is 28 days))
- Short Form McGill Pain Questionnaire, SF-MPQ(At the first visit of Cycle 1, 2, 3, 5 (each cycle is 28 days))
- Patient Global Impression of Change, PGIC(At the first visit of Cycle 3, 5 (each cycle is 28 days))
- Short Form-12 Health Survey version 2, SF-12 v2(At the first visit of Cycle 1, 2, 3, 5 (each cycle is 28 days))