Posterior Tibia Nerve Neuroprolotherapy for Dysmenorrhea

Taichung Armed Forces General Hospital

Status and phase: Enrolling; Early Phase 1

Conditions: Prolotherapy; Dysmenorrhea

Treatments: Procedure: Posterior tibial nerve neuroprolotherapy; Drug: Acetaminophen 500Mg Tab

Study type: Interventional

Funder types: Other

Identifiers

NCT06294743

C202304001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Group-1

Experimental group

Description:

Posterior tibial nerve neuroprolotherapy will be administered during the first two menstrual cycles, followed by oral acetaminophen (500mg) for the subsequent two menstrual cycles

Treatment:

Procedure: Posterior tibial nerve neuroprolotherapy

Drug: Acetaminophen 500Mg Tab

Group-2

Experimental group

Description:

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.

Treatment:

Procedure: Posterior tibial nerve neuroprolotherapy

Drug: Acetaminophen 500Mg Tab