Physiotherapy Treatment With Capacitive Resistive Monopolar Radiofrecuency in Young Women With Dyspareunia
Condition: Dyspareunia; Female
MeSH terms: Dyspareunia
Study type: Interventional

Summary: 
      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.
    

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.
    

Intervention name(s): Physical therapy modalities on pelvic floor (manual therapy); CRMRF; Sham CRMRF
Intervention type(s): Procedure; Device; Device
Intervention description(s): Intravaginal treatment (perineal massage); 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; The physical therapist applies the same treatment as the Treatment Group but the device is switched off.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Capacitive Resistive Monopolar Radiofrecuency; Sexual Dysfunction, Physiological; Pelvic floor; Physical Therapy Modalities; Musculoskeletal Manipulations