Posterior Tibia Nerve Neuroprolotherapy for Dysmenorrhea
NCT06294743 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2024-03-06
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
Interventions
- 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.
Sponsors & Collaborators
-
Taichung Armed Forces General Hospital
lead OTHER_GOV
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-11-23
- Primary Completion
- 2025-12-31
- Completion
- 2025-12-31
Countries
- Taiwan
Study Locations
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