Radiofrequency and Pelvic Floor Exercise for Primary Dysmenorrhea
Effectiveness of Radiofrequency and Physical Exercise on Symptoms Associated With Primary Dysmenorrhea: a Randomised Clinical Trial
The goal of this clinical trial is to learn whether radiofrequency (a heat-producing electrotherapy applied through an intravaginal electrode and over the abdomen), a supervised pelvic floor and core exercise programme, or both together reduce menstrual pain in women aged 18 to 35 years with primary dysmenorrhea. The main question it aims to answer is: do the three treatments differ in menstrual pain intensity (0-10 visual analogue scale)? Researchers will also compare pain quality, use of painkillers, quality of life, sexual function, premenstrual symptoms, pelvic floor muscle function and satisfaction with treatment, up to 1 year after treatment.
One hundred and twenty women will be randomly assigned to one of three groups:
- Radiofrequency: eight weekly sessions of about 30 minutes.
- Exercise: 16 supervised group sessions of 45 minutes (twice a week for 8 weeks).
- Combined: both treatments. Participants will complete questionnaires, a pain-medication diary and a pelvic floor examination before treatment and 1 week, 6 months and 1 year after treatment.
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Szczegółowy opis
Background. Primary dysmenorrhea affects more than 60% of women under 25 years and is a leading cause of school and work absenteeism. First-line treatment with non-steroidal anti-inflammatory drugs or oral contraceptives fails in 20-25% of women and causes side effects. Heat therapy reduces menstrual pain, and capacitive-resistive radiofrequency (RF) has reduced pain in chronic pelvic pain. Exercise is the reference conservative treatment for primary dysmenorrhea, but no trial has compared intravaginal RF, exercise and their combination.
Design. Randomised clinical trial with three parallel arms and 1:1:1 allocation, conducted at a gynaecology clinic in Elche, Spain (NG Clínicas - Juana Lafaja Mazuecos) in collaboration with Universidad CEU Cardenal Herrera. At baseline, a gynaecologist performs a transvaginal ultrasound in the proliferative phase to exclude secondary dysmenorrhea and to record uterine position. An investigator blinded to the baseline assessments generates the allocation sequence with SAS 9.4; allocation is kept in sealed, opaque, numbered envelopes. The statistician is blinded to allocation. Participants and therapists cannot be blinded.
Interventions. RF (Capenergy C500 Urogyne, capacitive transfer): eight weekly sessions. Each session starts with an athermic application for 10 minutes, with the active plate on the abdomen and the passive plate on the lumbar region. This is followed by an intravaginal application with a covered, lubricated MJS electrode for 20 minutes at a high thermal sensation (up to 43-44 °C), sweeping from 3 to 9 o'clock towards the vaginal fornix according to uterine position. Exercise: 16 group sessions (up to 8 participants) of 45 minutes, twice a week for 8 weeks, led by a physiotherapist. The programme combines pelvic floor and core activation, strength, aerobic and relaxation exercises, with progression after week 4. The combined group receives both.
Outcomes. The primary outcome is menstrual pain intensity on a visual analogue scale. Secondary outcomes are the McGill Pain Questionnaire, analgesic consumption (diary), EQ-5D, Female Sexual Function Index, Premenstrual Symptoms Screening Tool, pelvic floor muscle function (PERFECT scheme, modified Oxford scale and Phenix manometry) and treatment satisfaction. Assessments take place at baseline, 1 week, 6 months and 1 year after the end of treatment.
Sample size and analysis. A total of 120 women (40 per arm), assuming 25% attrition, α = 0.05 and 80% power. Intention-to-treat analysis using repeated-measures ANOVA (group × time) in SPSS 29.
Ethics. Approved by the Biomedical Research Ethics Committee of Universidad CEU Cardenal Herrera (CEEI25/670, 7 April 2025).
Typ studiów
Typ studiów
Zapisy (Szacowany)
Zapisy
Faza
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
Kontakt w sprawie studiów
- Nazwa: SERGIO MONTERO NAVARRO, PhD
- Numer telefonu: 67604 +34 965 42 64 86
- E-mail: sergio.montero@uchceu.es
Kopia zapasowa kontaktu do badania
- Nazwa: Cristina Orts-Ruiz, PhD
- E-mail: cristina.orts@uchceu.es
Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Women aged 18 to 35 years with a regular menstrual cycle (24 to 35 days).
- Normal genital ultrasound without clinical signs of organic disease.
- Primary dysmenorrhea present in all menstrual cycles since menarche.
- Menstrual pain of 5 or more on a 0-10 visual analogue scale.
- Body mass index between 20 and 30 kg/m².
Exclusion Criteria:
- Gynaecological findings consistent with secondary dysmenorrhea (pelvic inflammatory disease, uterine fibroids, polyps, endometriosis, adenomyosis, cervicitis).
- Pregnancy, or breastfeeding at the time of the study.
- Use of an intrauterine contraceptive device.
- Physiotherapist-supervised pelvic floor muscle training, or radiofrequency to the pelvic region, in the previous 12 months.
- Inability to understand study information (cognitive impairment).
- Peripheral or central neurological disorders.
- Previous pelvic surgery.
- Skin disease or wounds in the treatment area.
- Active urinary tract or vaginal infection.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Liczba ramion
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
|---|---|
|
Eksperymentalny: Radiofrequency
Eight weekly sessions of capacitive radiofrequency: athermic abdominal-lumbar application (10 min) followed by intravaginal application (20 min). |
Capenergy C500 Urogyne (capacitive transfer; 0.8, 1 and 1.2 MHz; temperature sensor). (1) Athermic application for 10 min with the active plate on the abdomen and the passive plate on the lumbar region. (2) Intravaginal application with a covered, lubricated MJS electrode for 20 min at a high thermal sensation (up to 43-44 °C), sweeping from 3 to 9 o'clock; the electrode orientation and passive plate position (lumbosacral or abdominal) depend on uterine position on ultrasound. Eight sessions at 7-day intervals. Temperature reached and delivered energy (kJ) are recorded each session. |
|
Aktywny komparator: Therapeutic exercise
Supervised pelvic floor and core exercise programme in groups of up to 8: 45-minute sessions twice a week for 8 weeks (16 sessions). |
First session individual, with anatomy, breathing and technique checked by digital testing. The following sessions are group-based: pelvic floor and transversus activation, glute bridge variations, resisted expiration and apnoea exercises, balance and motor control, squats and lunges, planks, and kettlebell work from week 4. Each session ends with active stretching and relaxation. Two different sessions per week for 8 weeks, 45 min each. |
|
Eksperymentalny: Radiofrequency + therapeutic exercise
Both interventions over the same 8-week period. |
Capenergy C500 Urogyne (capacitive transfer; 0.8, 1 and 1.2 MHz; temperature sensor). (1) Athermic application for 10 min with the active plate on the abdomen and the passive plate on the lumbar region. (2) Intravaginal application with a covered, lubricated MJS electrode for 20 min at a high thermal sensation (up to 43-44 °C), sweeping from 3 to 9 o'clock; the electrode orientation and passive plate position (lumbosacral or abdominal) depend on uterine position on ultrasound. Eight sessions at 7-day intervals. Temperature reached and delivered energy (kJ) are recorded each session. First session individual, with anatomy, breathing and technique checked by digital testing. The following sessions are group-based: pelvic floor and transversus activation, glute bridge variations, resisted expiration and apnoea exercises, balance and motor control, squats and lunges, planks, and kettlebell work from week 4. Each session ends with active stretching and relaxation. Two different sessions per week for 8 weeks, 45 min each. |
Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Menstrual pain intensity (Visual Analogue Scale)
Ramy czasowe: Baseline and 1 week after the end of the 8-week intervention
|
Menstrual pain on a 0-10 cm visual analogue scale (0 = no pain, 10 = worst pain). Higher scores indicate worse pain |
Baseline and 1 week after the end of the 8-week intervention
|
Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Menstrual pain intensity during follow-up (VAS)
Ramy czasowe: 6 months and 1 year after the end of the intervention
|
0-10 cm VAS as for the primary outcome. |
6 months and 1 year after the end of the intervention
|
|
Pain quality (McGill Pain Questionnaire)
Ramy czasowe: Baseline, and 1 week, 6 months and 1 year after the end of the 8-week intervention.
|
Pain descriptors chosen from 20 subclasses, each with a specific score. Higher scores indicate greater pain. |
Baseline, and 1 week, 6 months and 1 year after the end of the 8-week intervention.
|
|
Analgesic consumption
Ramy czasowe: Each menstrual cycle during the 8-week intervention
|
Number of analgesic doses taken for menstrual pain per cycle, recorded in a diary (date, time, drug and amount). |
Each menstrual cycle during the 8-week intervention
|
|
Health-related quality of life (EQ-5D)
Ramy czasowe: Baseline, and 1 week, 6 months and 1 year after the end of the 8-week intervention.
|
EuroQol-5D, five dimensions scored at 3 levels, plus a 0-100 visual analogue scale of health status. Higher VAS scores indicate better health. |
Baseline, and 1 week, 6 months and 1 year after the end of the 8-week intervention.
|
|
Sexual function (FSFI)
Ramy czasowe: Baseline, and 1 week, 6 months and 1 year after the end of the 8-week intervention.
|
Female Sexual Function Index, total score (range 2-36) over the previous 4 weeks. Scores of 26.55 or lower indicate sexual dysfunction; higher scores indicate better function. |
Baseline, and 1 week, 6 months and 1 year after the end of the 8-week intervention.
|
|
Premenstrual symptoms (PSST)
Ramy czasowe: Baseline, and 1 week, 6 months and 1 year after the end of the 8-week intervention.
|
Premenstrual Symptoms Screening Tool: 14 symptom items (total 0-42; higher scores indicate more severe symptoms) and 5 items on functional impact. |
Baseline, and 1 week, 6 months and 1 year after the end of the 8-week intervention.
|
|
Pelvic floor muscle function (PERFECT scheme and modified Oxford scale)
Ramy czasowe: Baseline, and 1 week, 6 months and 1 year after the end of the 8-week intervention.
|
Digital vaginal assessment: power (modified Oxford 0-5), endurance (s), repetitions and fast contractions (number per 10 s). |
Baseline, and 1 week, 6 months and 1 year after the end of the 8-week intervention.
|
|
Intravaginal pressure (manometry)
Ramy czasowe: Baseline, and 1 week, 6 months and 1 year after the end of the 8-week intervention.
|
Phenix Liberty manometer with an air-filled probe: resting tone and mean of three maximal contractions held for 10 sec. |
Baseline, and 1 week, 6 months and 1 year after the end of the 8-week intervention.
|
|
Treatment satisfaction
Ramy czasowe: 1 week after the end of the intervention
|
Five-point Likert scale (1 = very dissatisfied, 5 = very satisfied). |
1 week after the end of the intervention
|
Inne miary wyników
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Adverse events
Ramy czasowe: From the first session to 1 year after the intervention
|
Number of participants with adverse events (e.g. burns, marked irritation or persistent pain), by group. |
From the first session to 1 year after the intervention
|
Współpracownicy i badacze
Sponsor
Sponsor
Współpracownicy
Współpracownicy
Śledczy
Śledczy
- Główny śledczy: Cristina Orts-Ruiz, PhD, CEU Cardenal Herrera University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Rozpoczęcie studiów
Zakończenie podstawowe (Szacowany)
Zakończenie podstawowe
Ukończenie studiów (Szacowany)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- CEEI25/670
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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