Posterior Tibia Nerve Neuroprolotherapy for Dysmenorrhea

Dysmenorrhea Clinical Trial

Official title:

The Treatment Efficacy of Posterior Tibia Nerve Neuroprolotherapy on Dysmenorrhea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06294743
• Other study ID #: C202304001
• Status: Recruiting
• Phase: Early Phase 1
• Start date: November 23, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Taichung Armed Forces General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dysmenorrhea

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Taichung Armed Forces General Hospital	Taichung	Other (Non US)

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Armed Forces General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale	The visual analogue scale ranged from 0(no pain) to 10(severe pain)	Baseline, 1st month,2nd month,3rd month,4th month.
Secondary	The SF-36v2® Health Survey	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	Baseline, 1st month,2nd month,3rd month,4th month.