Posterior Tibia Nerve Neuroprolotherapy for Dysmenorrhea

Early Phase 1

Recruiting

• Conditions: Dysmenorrhea; Prolotherapy
• Interventions: Procedure: Posterior tibial nerve neuroprolotherapy; Drug: Acetaminophen 500Mg Tab

• Registration Number: NCT06294743
• Lead Sponsor: Taichung Armed Forces General Hospital

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.

Study Timeline

• Study Start: 2023-11-23
• Study First Submitted: 2024-02-14
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-02
• Last Update Submitted: 2024-03-02
• Study First Posted: 2024-03-06
• Last Update Posted: 2024-03-06
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• women aged 18-50 who experience normal menstrual cycles accompanied by menstrual pain

Exclusion Criteria

• Malignant tumors requiring treatment.
• Pregnant
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group-1	Acetaminophen 500Mg Tab	Posterior tibial nerve neuroprolotherapy will be administered during the first two menstrual cycles, followed by oral acetaminophen (500mg) for the subsequent two menstrual cycles
Group-1	Posterior tibial nerve neuroprolotherapy	Posterior tibial nerve neuroprolotherapy will be administered during the first two menstrual cycles, followed by oral acetaminophen (500mg) for the subsequent two menstrual cycles
Group-2	Posterior tibial nerve neuroprolotherapy	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.
Group-2	Acetaminophen 500Mg Tab	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.

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale	Baseline, 1st month,2nd month,3rd month,4th month.	The visual analogue scale ranged from 0(no pain) to 10(severe pain)

Secondary Outcome Measures

Name	Time	Method
The SF-36v2® Health Survey	Baseline, 1st month,2nd month,3rd month,4th month.	The SF-36 questionnaire is a short-form health survey that measures each of the following eight health domains: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Each health domain score contributes to the Physical Component Summary (PCS) and Mental Component Summary (MCS) scores

Trial Locations

Locations (1)

Taichung Armed Forces General Hospital; 🇨🇳 Taichung, Other (Non US), Taiwan