The Treatment Efficacy of Posterior Tibia Nerve Neuroprolotherapy on Dysmenorrhea
Overview
- Phase
- Early Phase 1
- Intervention
- Posterior tibial nerve neuroprolotherapy
- Conditions
- Dysmenorrhea
- Sponsor
- Taichung Armed Forces General Hospital
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Visual Analogue Scale
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Jing-Dung, SHEN
Chief Attending
Taichung Armed Forces General Hospital
Eligibility Criteria
Inclusion Criteria
- •women aged 18-50 who experience normal menstrual cycles accompanied by menstrual pain
Exclusion Criteria
- •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.
Arms & Interventions
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
Intervention: Posterior tibial nerve neuroprolotherapy
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
Intervention: Acetaminophen 500Mg Tab
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.
Intervention: Posterior tibial nerve neuroprolotherapy
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.
Intervention: Acetaminophen 500Mg Tab
Outcomes
Primary Outcomes
Visual Analogue Scale
Time Frame: Baseline, 1st month,2nd month,3rd month,4th month.
The visual analogue scale ranged from 0(no pain) to 10(severe pain)
Secondary Outcomes
- The SF-36v2® Health Survey(Baseline, 1st month,2nd month,3rd month,4th month.)