The Treatment Efficacy of Posterior Tibia Nerve Neuroprolotherapy on Dysmenorrhea
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Visual Analogue Scale
研究概览
简要总结
The goal of this crossover study is to assessed the treatment efficacy of posterior tibia nerve neuroprolotherapy on dysmenorrhea. The primary outcome is the improvement of Visual Analogue Scale. The main question it aims to answer is:
•Could the posterior tibial nerve neuroprolotherapy alleviate the pain of dysmenorrhea.
Participants will be randomly allocated into two groups, Group-1 will receive neuroprolotherapy in the first 2 menstrual cycles followed by oral acetaminophen(500mg) for the subsequent 2 menstrual cycles. Group02 will received oral acetaminophen(500mg) in initial 2 menstrual cycles, followed by receiving neuroprolotherapy for the subsequent 2 menstrual cycles.
详细描述
This trial is a crossover study involving the enrollment of 60 women aged 20-50 who experience normal menstrual cycles accompanied by menstrual pain. These participants will be randomly allocated into two distinct groups. In Group-1, posterior tibial nerve neuroprolotherapy will be administered during the first two menstrual cycles, followed by oral acetaminophen (500mg) for the subsequent two menstrual cycles. Conversely, in Group-2, oral acetaminophen (500mg) will be given during the initial two menstrual cycles, followed by a transition to posterior tibial nerve neuroprolotherapy for the last two menstrual cycles. The primary outcome measure for this trial is the improvement in the Visual Analog Scale (VAS). Secondary outcomes include an assessment of changes in quality of life before and after treatment, as evaluated using the SF-36 questionnaire. Furthermore, pulse diagnosis instruments will be employed to analyze alterations in meridian energy before and after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women aged 18-50 who experience normal menstrual cycles accompanied by menstrual pain
排除标准
- •Malignant tumors requiring treatment.
- •Those who have other acute and chronic pain and are receiving relevant drug treatment.
- •Those who are allergic to acetaminophen or have contraindications.
- •Those who use hormonal contraceptives at the same time.
- •Those with coagulation disorders or taking anticoagulant drugs.
研究组 & 干预措施
Group-1
Posterior tibial nerve neuroprolotherapy will be administered during the first two menstrual cycles, followed by oral acetaminophen (500mg) for the subsequent two menstrual cycles
干预措施: Posterior tibial nerve neuroprolotherapy (Procedure)
Group-1
Posterior tibial nerve neuroprolotherapy will be administered during the first two menstrual cycles, followed by oral acetaminophen (500mg) for the subsequent two menstrual cycles
干预措施: Acetaminophen 500Mg Tab (Drug)
Group-2
Oral acetaminophen (500mg) will be given during the initial two menstrual cycles, followed by a transition to posterior tibial nerve neuroprolotherapy for the last two menstrual cycles.
干预措施: Posterior tibial nerve neuroprolotherapy (Procedure)
Group-2
Oral acetaminophen (500mg) will be given during the initial two menstrual cycles, followed by a transition to posterior tibial nerve neuroprolotherapy for the last two menstrual cycles.
干预措施: Acetaminophen 500Mg Tab (Drug)
结局指标
主要结局
Visual Analogue Scale
时间窗: Baseline, 1st month,2nd month,3rd month,4th month.
The visual analogue scale ranged from 0(no pain) to 10(severe pain)
次要结局
- The SF-36v2® Health Survey(Baseline, 1st month,2nd month,3rd month,4th month.)
研究者
Jing-Dung, SHEN
Chief Attending
Taichung Armed Forces General Hospital