Physiotherapy Treatment With Capacitive Resistive Monopolar Radiofrecuency in Young Women With Dyspareunia ([CRMRF])

April 25, 2023 updated by: Escoles Universitaries Gimbernat

The hypothesis of this study is that capacitive-resistive monopolar radiofrecuency (CRMRF) with vaginal manual physiotherapy improves sexual health in young women suffering from dyspareunia (pain during sexual intercourse). The realization of studies that help to know the therapeutic possibilities in the field of dyspareunia seems necessary, taking into account the number of women affected, as well as the deficits of scientific evidence in this field.

The main objective of this study is to analyze whether the use of CRMRF brings additional benefits to the results of manual therapy on dyspareunia in young women.

Likewise, it intends to analyze the data for two secondary objectives:

  1. Analyze changes in different areas of women's sexual function in young people with dyspareunia through treatment (Desire, arousal, lubrication, orgasm, satisfaction and pain).
  2. Study if the use of CRMRF is an added benefit in personal perception while receiving treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After being informed of the study objectives, inclusion and exclusion criteria, and study methodology, all patients have signed informed consents. The participation of women in this study is entirely voluntary and if, during the course of the study, a participant decides to withdraw, she can do it freely at the time she considers appropriate, without the need to give explanations.

At week 0, patients who meet the eligibility requirements will be randomized using "Random.org" in a single-blind manner (participant) in two Arms:

  1. Treatment Group (CRMRF and physical therapy modalities on pelvic floor)
  2. Sham Group (only physical therapy modalities on pelvic floor).

There will be 4 identical treatment sessions (one each week). These sessions are protocolized. Data collection will be carried out before the first session, after the last session and 12 weeks after the end of the treatment. The approximate duration of each session is 40 minutes. Sessions with data collection will be approximately between 45 minutes to 1 hour.

During the first visit, patients will be asked to answer a series of questions and respond to some questionnaires (FSFI, Female Sexual Function Index and FSM, Women's Sexual Function). The results of the different tests carried out, as well as all the documentation referring to the participants, are totally confidential and will only be available to the main researcher, the collaborators and the health authorities competent, if applicable.

All necessary security measures so that study participants are not identified and confidentiality measures in all cases will be complete, in accordance with Regulation 2016/679 of the European Parliament and of the Council of April 27, 2016 on the + protection of natural persons (RGPD) and Organic Law 3/2018, of December 5, Protection of Personal Data and Guarantee of Digital Rights (LOPD-GDD).

During treatment, the patient will be placed in the supine position for the treatment, in litotonic position, because in this position the abdominal muscles and coxofemoral joints will be relaxed. The manual therapy techniques in the two groups will be based on Thiele's perineal massage, which consists of a massage from the origin to the insertion of the levator anus muscle with an amount of pressure tolerable by the patient. The maneuver will be performed by performing a back and forth movement over the entire palpable surface of muscle.

CRMRF will be performed on the treatment group with two types of active electrodes that, throughout the treatment, will be kept moving to avoid heat concentration.

  1. An external capacitive electrode, flat, stainless steel and coated with polyamide of 3cm diameter (ECE), which will act on the superficial tissues, skin, mucosa and muscle. It will be used externally bordering the external vaginal lips while the physiotherapist performs the perineal massage with the other hand.
  2. An internal, cylindrical, stainless steel resistive electrode, 8 cm long and 1.5 cm in diameter (ERI). It has a plastic screw-on cap to prevent heat concentration. The application will be endocavitary, in direct contact with the intravaginal tissue of the woman.

Throughout all the treatment the patient will have a passive electrode on her back, which will be a rectangular return plate. To perform the treatment, an Intradermik equipment (Rös's Estética), a conductive gel (Clear Ultrasound Gel, OXD Professional Care, REF US-C1) and the 2 different types of electrodes are used.

Participants will be blinded. As a masking technique, patients will be told that the intervention can produce a sensation of increased temperature in the area of application but that it does not always have to occur. Placing of the device will not allow participants to see the monitor. In the Sham Group, the CRMRF device is off.

The data obtained as study variables will be coded during the study, processed and analyzed.The sample population to be used in the analyses will include all participants who meet all inclusion criteria, except those who have decided to leave the study before its completion.

Statistical analysis will be performed with IBM SPSS Statistics (v20) software to assess the primary and secondary objectives and hypotheses of the study, including:

  • Tests of normality of the variables.
  • Analysis of the description variables of the complete sample: percentages, contingency tables, descriptive statistics (mean, standard deviation, median, minimum and maximum).
  • Analysis of the sample description variables, by groups: percentages, contingency tables, descriptive statistics (mean, standard deviation, median, minimum and maximum).
  • Comparison of means in related samples, separated by groups: T-test for mean difference (variables with normal distribution) and non-parametric Wilcoxon test (variables with non-normal distribution). The following comparisons are made: Final - Initial, ReTest - Final, ReTest - Initial.
  • Comparison of means between groups.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Sant Cugat Del Vallès, Barcelona, Spain, 08174
        • Escoles Universitaries Gimbernat

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Women between 18 and 30 years old.
  • Women who have pain during sexual intercourse, classified as dyspareunia superficial in the last 12 months.

Exclusion Criteria:

  • Use of antidepressants.
  • Pregnancy and lactation.
  • Cardiac pathologies.
  • Epilepsy.
  • Acute inflammatory process.
  • Pacemaker.
  • Skin or mucous infections in the urogenital area.
  • Any alteration that prevents the understanding of the informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group
CRMRF and physical therapy modalities on pelvic floor.
Procedure: Physical therapy modalities on pelvic floor (manual therapy)
Intravaginal treatment (perineal massage)
Device: CRMRF

CRMRF application on pelvic floor:

  • Externally over the urogenital triangle of the patient,
  • Intracavitary application (intravaginal)
  • Externally over the urogenital triangle of the patient while the physical therapist performs the intracavitary manual therapy (intravaginal),

The device used is named "Intradermik" and it is the portable CRMRF device of the brand RÖS'S Estética SL.

It has these features:

  • Frequency: 448kHz
  • Capacitive power: 450 voltamperes
  • Resistive power: 200 watts
Sham Comparator: Sham Group
Only physical therapy modalities on pelvic floor. In this Arm the CRMRF is off.
Procedure: Physical therapy modalities on pelvic floor (manual therapy)
Intravaginal treatment (perineal massage)
Device: Sham CRMRF
The physical therapist applies the same treatment as the Treatment Group but the device is switched off.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain in sexual intercourse
Time Frame: Five months

The pain was described using the anamnesis, the pain score of the "FSFI" scale (Female Sexual Function Index) and the scale of pain "VAS" (Visual Analogue Scale) that is a numerical rating scale that goes from zero to ten. Zero represents the absence of pain and ten the greatest pain that the patient can imagine.

The pain was described also using vaginal dilators and seeing at which measure the pain begins.
Five months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Female sexual function
Time Frame: Five months
The female sexual function was described using the "FSFI" (Female Sexual Function Index) and the "FSM" (Women's Sexual Function).
Five months
Quality of sexual relations
Time Frame: Five months
The quality of sexual relations was described using the scale "VAS" (Visual Analogue Scale) that is a numerical rating scale that goes from zero to ten. Zero represents the absence of quality of sexual relations and ten the best quality of sexual relations that the patient can imagine, the score of satisfaction of the "FSFI" (Female Sexual Function Index) and the score of "FSM" (Women's Sexual Function).
Five months
Problems with vaginal penetration
Time Frame: Five months
The problems with vaginal penetration were described using the scale "FSM" (Women's Sexual Function).
Five months
State of the musculature of the pelvic floor
Time Frame: Five months
The state of the musculature of the pelvic floor was described using the physical exploration of the patient and a device called "EPI-No" that can detect pain by stretching.
Five months
Perception of treatment
Time Frame: Five months
The perception of treatment was described using specific questions in the anamnesis.
Five months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Escoles Universitaries Gimbernat

Investigators

  • Principal Investigator: Anna Abelló Pla, MSc, Escoles Universitaries Gimbernat
  • Study Director: Jordi Esquirol Caussa, PhD, Escoles Universitaries Gimbernat
  • Study Director: Judit Lleberia, Universitat Autonoma de Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 5, 2021

Primary Completion (Actual)

February 9, 2023

Study Completion (Actual)

February 9, 2023

Study Registration Dates

First Submitted

April 25, 2023

First Submitted That Met QC Criteria

April 25, 2023

First Posted (Estimate)

May 4, 2023

Study Record Updates

Last Update Posted (Estimate)

May 4, 2023

Last Update Submitted That Met QC Criteria

April 25, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EUGimbernat

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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