Aún no reclutaNCT07921381Registro de ClinicalTrials.gov

Radiofrequency and Pelvic Floor Exercise for Primary Dysmenorrhea

Primary Dysmenorrhea

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LO ESENCIAL

De qué trata este estudio

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Tipo de estudio: De intervención
Fase: No aplica
Rango de edad: 18 años - 35 años
Sexo admitido: Femenino
Voluntarios sanos: No aceptados
Participantes: 120 Estimado

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Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

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.

Leer la descripción completa

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).

¿Quién podría participar?

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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.

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación: Asignación al azar
Enmascaramiento: Enmascaramiento simple

Radiofrequency

Eight weekly sessions of capacitive radiofrequency: athermic abdominal-lumbar application (10 min) followed by intravaginal application (20 min).

Device: Capacitive radiofrequency

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).

Behavioral: Pelvic floor and core exercise programme

Radiofrequency + therapeutic exercise

Both interventions over the same 8-week period.

Device: Capacitive radiofrequency · Behavioral: Pelvic floor and core exercise programme

Capacitive radiofrequency DEVICE

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.

Pelvic floor and core exercise programme BEHAVIORAL

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.

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Menstrual pain intensity (Visual Analogue Scale)

Plazo: 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

Medidas secundarias

Menstrual pain intensity during follow-up (VAS)

Plazo: 6 months and 1 year after the end of the intervention

Menstrual pain intensity measured with a 10-cm Visual Analogue Scale (VAS), from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse pain.

Pain quality (McGill Pain Questionnaire)