Individualized Acupoint Therapy for Dysmenorrhea: An Exploratory Research Design Based on Meridian Measurement
Individualized Acupoint Therapy for Dysmenorrhea: An Exploratory Research Design and Feasibility Assessment Based on Meridian Measurement
Primary dysmenorrhea is a common condition that significantly affects young women's quality of life. Traditional Chinese Medicine (TCM) acupoint interventions are widely used for symptom relief; however, standardized fixed-acupoint approaches often overlook individual meridian status variations.
This pilot study aims to evaluate the feasibility, preliminary efficacy, and physiological responses of an individualized meridian-guided intervention for primary dysmenorrhea in females aged 18-30. Utilizing non-invasive skin electrical resistance measurements (AETOSCAN) to assess baseline meridian energy status, eligible dysmenorrhea participants will be randomized into two parallel arms: an individualized meridian-guided intervention group and a standardized fixed-acupoint group. Interventions will be administered twice weekly over a 4-week cycle. The primary outcomes focus on changes in pain severity (VAS), menstrual distress scores (MDQ), and objective meridian electrical characteristics.
Przegląd badań
Status
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: JING-YUN KANG
- Numer telefonu: 886-983726861
- E-mail: likestecla@gmail.com
Lokalizacje studiów
-
-
-
Taichung, Tajwan, 404327
- China Medical University Hospital
-
Kontakt:
- Yu-Chen Lee
- Numer telefonu: 3500 886-4-2205-3366
- E-mail: 005167@tool.caaumed.org.tw
-
Główny śledczy:
- Yu-Chen Lee
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- 20 female participants with a history of primary dysmenorrhea symptoms.
- 20 healthy female controls without significant dysmenorrhea symptoms.
- Age Range: Females aged 18-30 years.
- Menstrual Regularity: Regular menstrual cycles, defined as a cycle duration of 21-35 days.
- Menstrual Stability: Relatively stable menstrual patterns within the past 3 months.
- Informed Consent & Compliance: Willingness to comply with all measurement and intervention protocols, and provided signed written informed consent.
- Medication Management: Agreeing not to use additional analgesics or traditional conditioning treatments during the intervention period (or agreeing to accurately report and record any use).
Exclusion Criteria:
Major Gynecological Conditions:
- History of major gynecological disorders.
- Confirmed diagnosis of structural or organic gynecological conditions, including endometriosis, uterine fibroids, or polycystic ovary syndrome (PCOS).
Pharmacological Interference:
- Long-term use of medications that affect the menstrual cycle.
- Currently undergoing hormonal therapy or long-term administration of analgesics.
- Physiological States: Pregnancy or current breastfeeding.
- General Health Status: Recent acute systemic inflammation or major systemic illnesses.
- Prior Treatment Confounding: Recent receipt of intensive acupuncture, moxibustion, or related meridian-based therapies.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Aktywny komparator: Active Control: Standard Acupoint Group
Participants in this arm receive standardized, fixed-acupoint laser acupuncture (or sham-like press-needle/seeding on standard dysmenorrhea points such as SP6, CV4, CV6) regardless of their individual meridian electrical resistance profile.
|
Application of low-level laser acupuncture on predefined classic acupoints (SP6, CV4, CV6) for 20 minutes per session, twice per week for 4 consecutive weeks.
Application of low-level laser acupuncture tailored to individual meridian imbalance profiles identified by AETOSCAN, for 20 minutes per session, twice per week for 4 consecutive weeks.
|
|
Eksperymentalny: Experimental: Individualized Meridian-Guided Group
Participants in this arm receive individualized laser acupuncture based on real-time meridian electrical resistance measurements using AETOSCAN prior to each intervention session.
|
Application of low-level laser acupuncture on predefined classic acupoints (SP6, CV4, CV6) for 20 minutes per session, twice per week for 4 consecutive weeks.
Application of low-level laser acupuncture tailored to individual meridian imbalance profiles identified by AETOSCAN, for 20 minutes per session, twice per week for 4 consecutive weeks.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Dysmenorrhea Pain Severity via Visual Analog Scale (VAS)
Ramy czasowe: Baseline (Pre-treatment), Mid-treatment (Week 2 of intervention), and Post-treatment (Week 4, immediately following intervention completion).
|
The Visual Analog Scale (VAS) is a 0-100 mm continuous scale used to measure subjective menstrual pain severity (0 = no pain, 100 = worst imaginable pain). Higher scores indicate greater pain intensity. Time Frame: Baseline (Pre-treatment), Mid-treatment (Week 2 of intervention), and Post-treatment (Week 4, immediately following intervention completion). |
Baseline (Pre-treatment), Mid-treatment (Week 2 of intervention), and Post-treatment (Week 4, immediately following intervention completion).
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Menstrual Distress Symptoms via Moos Menstrual Distress Questionnaire (MDQ Form C)
Ramy czasowe: Baseline (Pre-treatment), Mid-treatment (Week 2 of intervention), and Post-treatment (Week 4, immediately following intervention completion).
|
The MDQ Form C consists of 46 items across 8 subscales assessed on a 5-point Likert scale (0 = no symptom to 4 = severe symptom).
Total scores range from 0 to 184, with higher scores reflecting greater menstrual distress.
|
Baseline (Pre-treatment), Mid-treatment (Week 2 of intervention), and Post-treatment (Week 4, immediately following intervention completion).
|
|
Change in Meridian Electrical Resistance Profiles
Ramy czasowe: Baseline (Pre-treatment), Mid-treatment (Week 2 of intervention), and Post-treatment (Week 4, immediately following intervention completion).
|
Objective skin electrical resistance (in microamperes, µA) measured across twelve primary meridian Yuan-Source points using the AETOSCAN system to assess systemic physiological energy shifts.
|
Baseline (Pre-treatment), Mid-treatment (Week 2 of intervention), and Post-treatment (Week 4, immediately following intervention completion).
|
Współpracownicy i badacze
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- CMUH115-REC2-152
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .