Posterior Tibia Nerve Neuroprolotherapy for Dysmenorrhea

Last updated: March 2, 2024
Sponsor: Taichung Armed Forces General Hospital
Overall Status: Active - Recruiting

Phase

1

Condition

Severe Premenstrual Symptom

Menstrual Disorders

Female Hormonal Deficiencies/abnormalities

Treatment

Acetaminophen 500Mg Tab

Posterior tibial nerve neuroprolotherapy

Clinical Study ID

NCT06294743
C202304001
  • Ages 18-50
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Acetaminophen 500Mg Tab
Phase: 1
Study Start date:
November 23, 2023
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Taichung Armed Forces General Hospital

    Taichung, Other (Non US) 41168
    Taiwan

    Active - Recruiting

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