Posterior Tibia Nerve Neuroprolotherapy for Dysmenorrhea

NCT06294743 | Recruiting Early Phase 1

• 1 other identifier: C202304001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Dysmenorrhea; Prolotherapy

Keywords

dysmenorrhea; prolotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The SF-36v2® Health Survey

  Baseline, 1st month,2nd month,3rd month,4th month.

Study Arms (2)

Group-1

EXPERIMENTAL

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; Drug: Acetaminophen 500Mg Tab

Group-2

EXPERIMENTAL

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; Drug: Acetaminophen 500Mg Tab

Interventions

Posterior tibial nerve neuroprolotherapy PROCEDURE

Real-time ultrasound guided needle injecting 10ml of 5% dextrose solution around the posterior tibial nerve to elicit a neurostimulatory response.

Group-1; Group-2

Acetaminophen 500Mg Tab DRUG

Oral acetaminophen 500mg tab stat, followed by Q6h if needed.

Group-1; Group-2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: The patients who suffered with dysmenorrhea.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taichung Armed Forces General Hospital: lead

Study Sites (1)

Taichung Armed Forces General Hospital

Taichung, Other (Non US), 41168, Taiwan

RECRUITING

MeSH Terms

Conditions

Dysmenorrhea

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Attending

Model Details: 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. 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.

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: March 6, 2024
• Study Start: November 23, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)