Physiotherapy Treatment With Capacitive Resistive Monopolar Radiofrecuency in Young Women With Dyspareunia

NCT05844189 | Completed

• 1 other identifier: EUGimbernat
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.Study if the use of CRMRF is an added benefit in personal perception while receiving treatment.

Conditions

Dyspareunia; Female

Keywords

Capacitive Resistive Monopolar Radiofrecuency; Sexual Dysfunction, Physiological; Pelvic floor; Physical Therapy Modalities; Musculoskeletal Manipulations

Outcome Measures

Primary Outcomes (1)

• Pain in sexual intercourse

  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 Outcomes (5)

• Female sexual function

  Five months

• Quality of sexual relations

  Five months

• Problems with vaginal penetration

  Five months

• State of the musculature of the pelvic floor

  Five months

• Perception of treatment

  Five months

Study Arms (2)

Treatment Group

EXPERIMENTAL

CRMRF and physical therapy modalities on pelvic floor.

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

Sham Group

SHAM COMPARATOR

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

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

Interventions

Physical therapy modalities on pelvic floor (manual therapy) PROCEDURE

Intravaginal treatment (perineal massage)

Sham Group; Treatment Group

CRMRF DEVICE

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

Treatment Group

Sham CRMRF DEVICE

The physical therapist applies the same treatment as the Treatment Group but the device is switched off.

Sham Group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Escoles Universitaries Gimbernat: lead

Study Sites (1)

Escoles Universitaries Gimbernat

Sant Cugat del Vallès, Barcelona, 08174, Spain

Location

Related Publications (16)

• Thomten J. Living with genital pain: Sexual function, satisfaction, and help-seeking among women living in Sweden. Scand J Pain. 2014 Jan 1;5(1):19-25. doi: 10.1016/j.sjpain.2013.10.002.

  PMID: 29913665 RESULT

• Elmerstig E, Wijma B, Swahnberg K. Young Swedish women's experience of pain and discomfort during sexual intercourse. Acta Obstet Gynecol Scand. 2009;88(1):98-103. doi: 10.1080/00016340802620999.

  PMID: 19140047 RESULT

• Hendrickx L, Gijs L, Enzlin P. Age-related prevalence rates of sexual difficulties, sexual dysfunctions, and sexual distress in heterosexual women: results from an online survey in flanders. J Sex Med. 2015 Feb;12(2):424-35. doi: 10.1111/jsm.12725. Epub 2014 Oct 27.

  PMID: 25345486 RESULT

• Mitchell KR, Geary R, Graham CA, Datta J, Wellings K, Sonnenberg P, Field N, Nunns D, Bancroft J, Jones KG, Johnson AM, Mercer CH. Painful sex (dyspareunia) in women: prevalence and associated factors in a British population probability survey. BJOG. 2017 Oct;124(11):1689-1697. doi: 10.1111/1471-0528.14518. Epub 2017 Jan 25.

  PMID: 28120373 RESULT

• Demirel G, Golbasi Z. Effect of perineal massage on the rate of episiotomy and perineal tearing. Int J Gynaecol Obstet. 2015 Nov;131(2):183-6. doi: 10.1016/j.ijgo.2015.04.048. Epub 2015 Jul 26.

  PMID: 26410801 RESULT

• Leon-Larios F, Corrales-Gutierrez I, Casado-Mejia R, Suarez-Serrano C. Influence of a pelvic floor training programme to prevent perineal trauma: A quasi-randomised controlled trial. Midwifery. 2017 Jul;50:72-77. doi: 10.1016/j.midw.2017.03.015. Epub 2017 Mar 27.

  PMID: 28391147 RESULT

• Takeuchi S, Horiuchi S. Randomised controlled trial using smartphone website vs leaflet to support antenatal perineal massage practice for pregnant women. Women Birth. 2016 Oct;29(5):430-435. doi: 10.1016/j.wombi.2016.01.010. Epub 2016 Feb 19.

  PMID: 26906970 RESULT

• Spottorno J, Gonzalez de Vega C, Buenaventura M, Hernando A. Influence of electrodes on the 448 kHz electric currents created by radiofrequency: A finite element study. Electromagn Biol Med. 2017;36(3):306-314. doi: 10.1080/15368378.2017.1354015. Epub 2017 Jul 31.

  PMID: 28759286 RESULT

• Silva AP, Montenegro ML, Gurian MB, Mitidieri AM, Lara LA, Poli-Neto OB, Rosa E Silva JC. Perineal Massage Improves the Dyspareunia Caused by Tenderness of the Pelvic Floor Muscles. Rev Bras Ginecol Obstet. 2017 Jan;39(1):26-30. doi: 10.1055/s-0036-1597651. Epub 2016 Dec 27.

  PMID: 28027568 RESULT

• Kumaran B, Watson T. Thermal build-up, decay and retention responses to local therapeutic application of 448 kHz capacitive resistive monopolar radiofrequency: A prospective randomised crossover study in healthy adults. Int J Hyperthermia. 2015;31(8):883-95. doi: 10.3109/02656736.2015.1092172. Epub 2015 Nov 2.

  PMID: 26524223 RESULT

• Trahan J, Leger E, Allen M, Koebele R, Yoffe MB, Simon C, Alappattu M, Figuers C. The Efficacy of Manual Therapy for Treatment of Dyspareunia in Females: A Systematic Review. J Womens Health Phys Therap. 2019 Jan-Mar;43(1):28-35. doi: 10.1097/jwh.0000000000000117.

  PMID: 34135723 RESULT

• Sanchez-Sanchez F, Ferrer-Casanova C, Ponce-Buj B, Sipan-Sarrion Y, Jurado-Lopez AR, San Martin-Blanco C, Tijeras-Ubeda MJ, Ferrandez Infante A. [Design and validation of the second edition of the Women's Sexual Function Questionnaire, FSM-2]. Semergen. 2020 Jul-Aug;46(5):324-330. doi: 10.1016/j.semerg.2020.01.004. Epub 2020 Mar 18. Spanish.

  PMID: 32197978 RESULT

• Sanchez-Sanchez B, Navarro-Brazalez B, Arranz-Martin B, Sanchez-Mendez O, de la Rosa-Diaz I, Torres-Lacomba M. The Female Sexual Function Index: Transculturally Adaptation and Psychometric Validation in Spanish Women. Int J Environ Res Public Health. 2020 Feb 5;17(3):994. doi: 10.3390/ijerph17030994.

  PMID: 32033334 RESULT

• Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597.

  PMID: 10782451 RESULT

• Fernandez-Cuadros ME, Kazlauskas SG, Albaladejo-Florin MJ, Robles-Lopez M, Laborda-Delgado A, de la Cal-Alvarez C, Perez-Moro O. [Effectiveness of multimodal rehabilitation (biofeedback plus capacitive-resistive radiofrequency) on chronic pelvic pain and dyspareunia: prospective study and literature review]. Rehabilitacion (Madr). 2020 Jul-Sep;54(3):154-161. doi: 10.1016/j.rh.2020.02.005. Epub 2020 May 6. Spanish.

  PMID: 32441260 RESULT

• Pla AA, Andreu-Povar A, Fabbi L, Esquirol-Caussa J, Lleberia-Juanos J, Gil-Moreno A, Omana MC. Evaluation of the efficacy of Capacitive Resistive Monopolar Radiofrequency at 448 kHz in the physiotherapeutic treatment of female dyspareunia. Contemp Clin Trials Commun. 2025 Jan 10;44:101433. doi: 10.1016/j.conctc.2025.101433. eCollection 2025 Apr.

  PMID: 39886027 DERIVED

MeSH Terms

Conditions

Dyspareunia; Sexual Dysfunction, Physiological

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Anna Abelló Pla, MSc

  Escoles Universitaries Gimbernat

  PRINCIPAL INVESTIGATOR

• Jordi Esquirol Caussa, PhD

  Escoles Universitaries Gimbernat

  STUDY DIRECTOR

• Judit Lleberia

  Universitat Autònoma de Barcelona

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 6, 2023
• Study Start: November 5, 2021
• Primary Completion: February 9, 2023
• Study Completion: February 9, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)