Clinical trial NCT06294743: Posterior Tibia Nerve Neuroprolotherapy for Dysmenorrhea
Official title: The Treatment Efficacy of Posterior Tibia Nerve Neuroprolotherapy on Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Dysmenorrhea
Prolotherapy
Keywords: dysmenorrhea
prolotherapy
Lead sponsor: Taichung Armed Forces General Hospital
Sponsor class: OTHER_GOV
First posted: 2024-03-06
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: Baseline, 1st month,2nd month,3rd month,4th month.
Secondary outcomes:
measure: The SF-36v2® Health Survey
timeFrame: Baseline, 1st month,2nd month,3rd month,4th month.
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Armed Forces General Hospital
state: Other (Non US)
Study officials:
References: