DysmenorrheaEarly Phase 1NCT06294743
Posterior Tibia Nerve Neuroprolotherapy for Dysmenorrhea
A Early Phase 1 study testing Posterior tibial nerve neuroprolotherapy and Acetaminophen 500Mg Tab in people with Dysmenorrhea and Prolotherapy, run by Taichung Armed Forces General Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Dysmenorrhea, Prolotherapy
- What is being tested?
- Posterior tibial nerve neuroprolotherapy and Acetaminophen 500Mg Tab
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 23 Nov 2023to 31 Dec 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women aged 18-50 who experience normal menstrual cycles accompanied by menstrual pain
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taichung Armed Forces General Hospital
Taichung, Other (Non US), 41168
Jing-dung Shen, MD, +886958878129, jdwhydo@gmail.com
Jing-dung Shen, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Dysmenorrhea, Prolotherapy
- Being tested
- Posterior tibial nerve neuroprolotherapy, Acetaminophen 500Mg Tab
- Keywords
- dysmenorrhea, prolotherapy
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior tibial nerve neuroprolotherapyProcedure or surgery
Real-time ultrasound guided needle injecting 10ml of 5% dextrose solution around the posterior tibial nerve to elicit a neurostimulatory response.
Acetaminophen 500Mg TabDrug
Oral acetaminophen 500mg tab stat, followed by Q6h if needed.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Procedure: Posterior tibial nerve neuroprolotherapy; Drug: Acetaminophen 500Mg Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
The visual analogue scale ranged from 0(no pain) to 10(severe pain)
Measured: Baseline, 1st month,2nd month,3rd month,4th month.
Secondary outcomes (1)
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
Measured: Baseline, 1st month,2nd month,3rd month,4th month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start23 Nov 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Armed Forces General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jing-Dung, SHEN, Taichung Armed Forces General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06294743
- Sponsor's protocol ID
- C202304001
- Status last verified
- Mar 2024
- First submitted
- 14 Feb 2024
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Treatment Efficacy of Posterior Tibia Nerve Neuroprolotherapy on Dysmenorrhea
- ClinicalTrials.gov ID
- NCT06294743
- Acronym / sponsor ID
- C202304001
- Conditions
- Dysmenorrhea, Prolotherapy
- Keywords
- dysmenorrhea, prolotherapy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taichung Armed Forces General HospitalOther government
- Study start
- 23 Nov 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group-1 | Experimental | Procedure: Posterior tibial nerve neuroprolotherapy, Drug: Acetaminophen 500Mg TabPosterior tibial nerve neuroprolotherapy will be administered during the first two menstrual cycles, followed by oral acetaminophen (500mg) for the subsequent two menstrual cycles |
| Group-2 | Experimental | Procedure: Posterior tibial nerve neuroprolotherapy, Drug: Acetaminophen 500Mg TabOral 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women aged 18-50 who experience normal menstrual cycles accompanied by menstrual pain
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Posterior tibial nerve neuroprolotherapyReal-time ultrasound guided needle injecting 10ml of 5% dextrose solution around the posterior tibial nerve to elicit a neurostimulatory response. | Procedure or surgery | Group-1, Group-2 |
| Acetaminophen 500Mg TabOral acetaminophen 500mg tab stat, followed by Q6h if needed. | Drug | Group-1, Group-2 |
Primary outcome
Visual Analogue Scale
Time frame: Baseline, 1st month,2nd month,3rd month,4th month.
The visual analogue scale ranged from 0(no pain) to 10(severe pain)
1 secondary outcome
The SF-36v2® Health Survey
Time frame: Baseline, 1st month,2nd month,3rd month,4th month.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Dysmenorrhea
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
Active, not recruiting
Mindfulness-Based Education For Women With Polycystic Ovary Syndrome
Polycystic Ovary Syndrome (PCOS), Menstrual Symptoms
Not yet recruiting
The Effect of a Ginger Formula on Menstrual Health vs a Placebo
Painful Menstruation
Active, not recruitingPhase 2
A Phase 2 Trial to Investigate Efficacy and Safety of Vipoglanstat in Women With Endometriosis
Endometriosis
Not yet recruiting
Transcutaneous Cervical Vagus Nerve Stimulation for Primary Dysmenorrhea
Primary Dysmenorrhea (PD), Menstrual Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Posterior tibial nerve neuroprolotherapy and Acetaminophen 500Mg Tab in people with Dysmenorrhea and Prolotherapy, run by Taichung Armed Forces General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: Baseline, 1st month,2nd month,3rd month,4th month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.