Primary DysmenorrheaNCT07921381
Radiofrequency and Pelvic Floor Exercise for Primary Dysmenorrhea
A study testing Capacitive radiofrequency and Pelvic floor and core exercise programme in people with Primary Dysmenorrhea, run by SERGIO MONTERO NAVARRO.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Primary Dysmenorrhea
- What is being tested?
- Capacitive radiofrequency and Pelvic floor and core exercise programme
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2027to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Previous pelvic surgery.
- Skin disease or wounds in the treatment area.
- Active urinary tract or vaginal infection.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Cristina Orts-Ruiz, PhD contact
About this study
Official title: 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.
Read the 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).
- Conditions
- Primary Dysmenorrhea
- Being tested
- Capacitive radiofrequency, Pelvic floor and core exercise programme
- Keywords
- Radiofrequency, Capacitive-resistive electric transfer, Pelvic floor muscle training, Therapeutic exercise, Menstrual pain, Women's health, Physiotherapy
- Medical subject headings
- Dysmenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capacitive radiofrequencyDevice
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 programmeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency | Experimental | Eight weekly sessions of capacitive radiofrequency: athermic abdominal-lumbar application (10 min) followed by intravaginal application (20 min). Receives: Device: Capacitive radiofrequency |
| Therapeutic exercise | Active comparator | Supervised pelvic floor and core exercise programme in groups of up to 8: 45-minute sessions twice a week for 8 weeks (16 sessions). Receives: Behavioral: Pelvic floor and core exercise programme |
| Radiofrequency + therapeutic exercise | Experimental | Both interventions over the same 8-week period. Receives: Device: Capacitive radiofrequency; Behavioral: Pelvic floor and core exercise programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and 1 week after the end of the 8-week intervention
Secondary outcomes (9)
Menstrual pain intensity during follow-up (VAS)
0-10 cm VAS as for the primary outcome.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 1 week after the end of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start30 Jan 2027 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-arm parallel randomised clinical trial (1:1:1) comparing radiofrequency, supervised pelvic floor and core exercise, and their combination.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SERGIO MONTERO NAVARRO
- Sponsor type
- University, hospital or other
- Collaborators
- CAPENERGY MEDICAL, SL, NG Clínicas - Clínica Ginecológica Juana Lafaja Mazuecos, Cardenal Herrera University
- Responsible party
- Sponsor-investigator, SERGIO MONTERO NAVARRO, Cardenal Herrera University
- Investigators
- Cristina Orts-Ruiz, PhD, Principal investigator, CEU Cardenal Herrera University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07921381
- Sponsor's protocol ID
- CEEI25/670
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Radiofrequency and Physical Exercise on Symptoms Associated With Primary Dysmenorrhea: a Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT07921381
- Acronym / sponsor ID
- CEEI25/670
- Conditions
- Primary Dysmenorrhea
- Keywords
- Radiofrequency, Capacitive-resistive electric transfer, Pelvic floor muscle training, Therapeutic exercise, Menstrual pain, Women's health, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- SERGIO MONTERO NAVARROUniversity, hospital or other
- Collaborators
- CAPENERGY MEDICAL, SL, NG Clínicas - Clínica Ginecológica Juana Lafaja Mazuecos, Cardenal Herrera University
- Study start
- 30 Jan 2027 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Three-arm parallel randomised clinical trial (1:1:1) comparing radiofrequency, supervised pelvic floor and core exercise, and their combination.
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency | Experimental | Device: Capacitive radiofrequencyEight weekly sessions of capacitive radiofrequency: athermic abdominal-lumbar application (10 min) followed by intravaginal application (20 min). |
| Therapeutic exercise | Active comparator | Behavioral: Pelvic floor and core exercise programmeSupervised pelvic floor and core exercise programme in groups of up to 8: 45-minute sessions twice a week for 8 weeks (16 sessions). |
| Radiofrequency + therapeutic exercise | Experimental | Device: Capacitive radiofrequency, Behavioral: Pelvic floor and core exercise programmeBoth interventions over the same 8-week period. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capacitive radiofrequencyCapenergy 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. | Device | Radiofrequency, Radiofrequency + therapeutic exercise |
| Pelvic floor and core exercise programmeFirst 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. | Behavioural | Radiofrequency + therapeutic exercise, Therapeutic exercise |
Primary outcome
Menstrual pain intensity (Visual Analogue Scale)
Time frame: 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
9 secondary outcomes
Menstrual pain intensity during follow-up (VAS)
Time frame: 6 months and 1 year after the end of the intervention
Pain quality (McGill Pain Questionnaire)
Time frame: Baseline, and 1 week, 6 months and 1 year after the end of the 8-week intervention.
Analgesic consumption
Time frame: Each menstrual cycle during the 8-week intervention
Health-related quality of life (EQ-5D)
Time frame: Baseline, and 1 week, 6 months and 1 year after the end of the 8-week intervention.
Sexual function (FSFI)
Time frame: Baseline, and 1 week, 6 months and 1 year after the end of the 8-week intervention.
Premenstrual symptoms (PSST)
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)
Time frame: Baseline, and 1 week, 6 months and 1 year after the end of the 8-week intervention.
Intravaginal pressure (manometry)
Time frame: Baseline, and 1 week, 6 months and 1 year after the end of the 8-week intervention.
Treatment satisfaction
Time frame: 1 week after the end of the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cristina Orts-Ruiz, PhD contact
Cristina Orts-Ruiz, PhD principal investigator
CEU Cardenal Herrera University
Questions about this trial
What is this clinical trial studying?
A study testing Capacitive radiofrequency and Pelvic floor and core exercise programme in people with Primary Dysmenorrhea, run by SERGIO MONTERO NAVARRO.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SERGIO MONTERO NAVARRO, PhD (+34 965 42 64 86 ext. 67604, sergio.montero@uchceu.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Menstrual pain intensity (Visual Analogue Scale) (time frame: Baseline and 1 week after the end of the 8-week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.