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.

Study Overview

• Status: Not yet recruiting
• Conditions: Primary Dysmenorrhea
• Intervention / Treatment: Device: Capacitive radiofrequency; Behavioral: Pelvic floor and core exercise programme

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: SERGIO MONTERO NAVARRO, PhD; Phone Number: 67604 +34 965 42 64 86; Email: sergio.montero@uchceu.es
• Study Contact Backup: Name: Cristina Orts-Ruiz, PhD; Email: cristina.orts@uchceu.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radiofrequency; Eight weekly sessions of capacitive radiofrequency: athermic abdominal-lumbar application (10 min) followed by intravaginal application (20 min).	Device: Capacitive radiofrequency; 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.
Active Comparator: 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; 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.
Experimental: Radiofrequency + therapeutic exercise; Both interventions over the same 8-week period.	Device: Capacitive radiofrequency; 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.; Behavioral: Pelvic floor and core exercise programme; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline and 1 week after the end of the 8-week intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Menstrual pain intensity during follow-up (VAS)	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)	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	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)	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)	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)	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)	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)	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	Five-point Likert scale (1 = very dissatisfied, 5 = very satisfied).	1 week after the end of the intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	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

Collaborators and Investigators

• Sponsor: SERGIO MONTERO NAVARRO
• Collaborators: Cardenal Herrera University; CAPENERGY MEDICAL, SL; NG Clínicas - Clínica Ginecológica Juana Lafaja Mazuecos
• Investigators: Principal Investigator: Cristina Orts-Ruiz, PhD, CEU Cardenal Herrera University

Study record dates

Study Major Dates

• Study Start (Estimated): January 30, 2027
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: November 2, 2026
• First Submitted That Met QC Criteria: November 2, 2026
• First Posted (Actual): November 6, 2026

Study Record Updates

• Last Update Posted (Actual): November 6, 2026
• Last Update Submitted That Met QC Criteria: November 2, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Keywords: Pelvic floor muscle training; Menstrual pain; Physiotherapy; Radiofrequency; Therapeutic exercise; Women's health; Capacitive-resistive electric transfer
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathologic Processes; Pelvic Pain; Menstruation Disturbances; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Dysmenorrhea
• Other Study ID Numbers: CEEI25/670

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No