NCT06294743

Posterior Tibia Nerve Neuroprolotherapy for Dysmenorrhea

The Treatment Efficacy of Posterior Tibia Nerve Neuroprolotherapy on Dysmenorrhea

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Taichung Armed Forces General Hospital · Other Government
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dysmenorrhea
• Prolotherapy

Interventions

Type	Name	Description
PROCEDURE	Posterior tibial nerve neuroprolotherapy	Real-time ultrasound guided needle injecting 10ml of 5% dextrose solution around the posterior tibial nerve to elicit a neurostimulatory response.
DRUG	Acetaminophen 500Mg Tab	Oral acetaminophen 500mg tab stat, followed by Q6h if needed.

Timeline

• Start date: 2023-11-23
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-03-06
• Last updated: 2024-03-06

Locations

1 site across 1 country: Taiwan