Posterior Tibia Nerve Neuroprolotherapy for Dysmenorrhea

The Treatment Efficacy of Posterior Tibia Nerve Neuroprolotherapy on Dysmenorrhea

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.

Study Overview

• Status: Recruiting
• Conditions: Dysmenorrhea; Prolotherapy
• Intervention / Treatment: Procedure: Posterior tibial nerve neuroprolotherapy; Drug: Acetaminophen 500Mg Tab

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Taiwan
  • Other (Non US)
    • Taichung, Other (Non US), Taiwan, 41168
      • Recruiting
      • Taichung Armed Forces General Hospital
      • Contact: Jing-dung Shen, MD; Phone Number: +886958878129; Email: jdwhydo@gmail.com
      • Principal Investigator: Jing-dung Shen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Taichung Armed Forces General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: February 14, 2024
• First Submitted That Met QC Criteria: March 2, 2024
• First Posted (Estimated): March 6, 2024

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 2, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: prolotherapy; dysmenorrhea
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Dysmenorrhea; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: C202304001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No