An interventional study of Capacitive radiofrequency and Pelvic floor and core exercise programme in Primary Dysmenorrhea, sponsored by SERGIO MONTERO NAVARRO. Not yet recruiting. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by SERGIO MONTERO NAVARRO · Not applicable, Interventional, and Treatment
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:
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).
430 studies on the registry are indexed under Dysmenorrhea; 107 are open to participants now.
This study's planned enrollment of 120 is above the median of 62 across 363 interventional studies indexed under Dysmenorrhea.
Browse Dysmenorrhea studies →SERGIO MONTERO NAVARRO is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Eight weekly sessions of capacitive radiofrequency: athermic abdominal-lumbar application (10 min) followed by intravaginal application (20 min).
Device: Capacitive radiofrequency
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
Both interventions over the same 8-week period.
Device: Capacitive radiofrequency · Behavioral: Pelvic floor and core exercise programme
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.
Menstrual pain intensity (Visual Analogue Scale)
Menstrual pain on a 0-10 cm visual analogue scale (0 = no pain, 10 = worst pain). Higher scores indicate worse pain
Time frame: Baseline and 1 week after the end of the 8-week intervention
Menstrual pain intensity during follow-up (VAS)
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.
Time frame: 6 months and 1 year after the end of the intervention
Pain quality (McGill Pain Questionnaire)
McGill Pain Questionnaire (MPQ). Participants select one descriptor from each of 20 subclasses that applies to their menstrual pain; each descriptor has a rank value. The total Pain Rating Index ranges from 0 to 78, with higher scores indicating greater pain.
Time frame: Baseline, and 1 week, 6 months and 1 year after the end of the 8-week intervention.
Analgesic consumption
Number of analgesic doses taken for menstrual pain per cycle, recorded in a diary (date, time, drug and amount).
Time frame: Each menstrual cycle during the 8-week intervention
Health-related quality of life (EQ-5D)
EuroQol-5D, five dimensions scored at 3 levels, plus a 0-100 visual analogue scale of health status. Higher VAS scores indicate better health.
Time frame: Baseline, and 1 week, 6 months and 1 year after the end of the 8-week intervention.
Sexual function (FSFI)
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.
Time frame: Baseline, and 1 week, 6 months and 1 year after the end of the 8-week intervention.
Premenstrual symptoms (PSST)
Premenstrual Symptoms Screening Tool: 14 symptom items (total 0-42; higher scores indicate more severe symptoms) and 5 items on functional impact.
Time frame: 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)
Digital vaginal assessment: power (modified Oxford 0-5), endurance (s), repetitions and fast contractions (number per 10 s).
Time frame: Baseline, and 1 week, 6 months and 1 year after the end of the 8-week intervention.
Intravaginal pressure (manometry)
Phenix Liberty manometer with an air-filled probe: resting tone and mean of three maximal contractions held for 10 sec.
Time frame: Baseline, and 1 week, 6 months and 1 year after the end of the 8-week intervention.
Treatment satisfaction
Five-point Likert scale (1 = very dissatisfied, 5 = very satisfied).
Time frame: 1 week after the end of the intervention
Adverse events
Number of participants with adverse events (e.g. burns, marked irritation or persistent pain), by group.
Time frame: From the first session to 1 year after the intervention
No study locations are listed for this record.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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