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

Escoles Universitaries Gimbernat

Status: Completed

Conditions: Dyspareunia; Female

Treatments: Device: Sham CRMRF; Procedure: Physical therapy modalities on pelvic floor (manual therapy); Device: CRMRF

Study type: Interventional

Funder types: Other

Identifiers

NCT05844189

EUGimbernat

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: Female

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups

Treatment Group

Experimental group

Description:

CRMRF and physical therapy modalities on pelvic floor.

Treatment:

Procedure: Physical therapy modalities on pelvic floor (manual therapy)

Device: CRMRF

Sham Group

Sham Comparator group

Description:

Only physical therapy modalities on pelvic floor. In this Arm the CRMRF is off.

Treatment:

Device: Sham CRMRF

Procedure: Physical therapy modalities on pelvic floor (manual therapy)