Dyspareunia; Female[CRMRF]NCT05844189
Physiotherapy Treatment With Capacitive Resistive Monopolar Radiofrecuency in Young Women With Dyspareunia
A study testing Physical therapy modalities on pelvic floor (manual therapy) and CRMRF in people with Dyspareunia; Female, run by Escoles Universitaries Gimbernat at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dyspareunia; Female
- What is being tested?
- Physical therapy modalities on pelvic floor (manual therapy) and CRMRF
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteSpain
- Study dates
- 5 Nov 2021to 9 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women between 18 and 30 years old.
- Women who have pain during sexual intercourse, classified as dyspareunia superficial in the last 12 months.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Spain1 site
Escoles Universitaries Gimbernat
Sant Cugat del Vallès, Barcelona, 08174
About this study
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.
Read more
Likewise, it intends to analyze the data for two secondary objectives:
- Analyze changes in different areas of women's sexual function in young people with dyspareunia through treatment (Desire, arousal, lubrication, orgasm, satisfaction and pain).
- Study if the use of CRMRF is an added benefit in personal perception while receiving treatment.
Read the 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:
- Treatment Group (CRMRF and physical therapy modalities on pelvic floor)
- 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.
- 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.
- 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.
- Conditions
- Dyspareunia; Female
- Being tested
- Physical therapy modalities on pelvic floor (manual therapy), CRMRF, Sham CRMRF
- Keywords
- Capacitive Resistive Monopolar Radiofrecuency, Sexual Dysfunction, Physiological, Pelvic floor, Physical Therapy Modalities, Musculoskeletal Manipulations
- Medical subject headings
- Dyspareunia, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical therapy modalities on pelvic floor (manual therapy)Procedure or surgery
Intravaginal treatment (perineal massage)
CRMRFDevice
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 CRMRFDevice
The physical therapist applies the same treatment as the Treatment Group but the device is switched off.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | CRMRF and physical therapy modalities on pelvic floor. Receives: 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. Receives: Procedure: Physical therapy modalities on pelvic floor (manual therapy); Device: Sham CRMRF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Five months
Secondary outcomes (5)
Female sexual function
The female sexual function was described using the "FSFI" (Female Sexual Function Index) and the "FSM" (Women's Sexual Function).
Measured: Five months
Quality of sexual relations
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).
Measured: Five months
Problems with vaginal penetration
The problems with vaginal penetration were described using the scale "FSM" (Women's Sexual Function).
Measured: Five months
State of the musculature of the pelvic floor
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.
Measured: Five months
Perception of treatment
The perception of treatment was described using specific questions in the anamnesis.
Measured: Five months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start5 Nov 2021
- Primary completion9 Feb 2023
- Study completion9 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Dyspareunia; FemaleStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Escoles Universitaries Gimbernat
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Abelló Pla, MSc, Principal investigator, Escoles Universitaries GimbernatJordi Esquirol Caussa, PhD, Study director, Escoles Universitaries GimbernatJudit Lleberia, Study director, Universitat Autònoma de Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05844189
- Sponsor's protocol ID
- EUGimbernat
- Acronym
- [CRMRF]
- Status last verified
- Apr 2023
- First submitted
- 25 Apr 2023
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29913665Elmerstig 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.
PubMed 19140047Hendrickx 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.
PubMed 25345486Mitchell 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.
PubMed 28120373Demirel 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.
PubMed 26410801Leon-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.
PubMed 28391147Takeuchi 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.
PubMed 26906970Spottorno 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.
PubMed 28759286Silva 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.
PubMed 28027568Kumaran 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.
PubMed 26524223Trahan 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.
PubMed 34135723Sanchez-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.
PubMed 32197978Sanchez-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.
PubMed 32033334Rosen 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.
PubMed 10782451Fernandez-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.
PubMed 32441260
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiotherapy Treatment With Capacitive Resistive Monopolar Radiofrecuency in Young Women With Dyspareunia
- ClinicalTrials.gov ID
- NCT05844189
- Acronym / sponsor ID
- [CRMRF] / EUGimbernat
- Conditions
- Dyspareunia; Female
- Keywords
- Capacitive Resistive Monopolar Radiofrecuency, Sexual Dysfunction, Physiological, Pelvic floor, Physical Therapy Modalities, Musculoskeletal Manipulations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Escoles Universitaries GimbernatUniversity, hospital or other
- Study start
- 5 Nov 2021 (actual)
- Primary completion
- 9 Feb 2023 (actual)
- Study completion
- 9 Feb 2023 (actual)
- First posted
- 6 May 2023 (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 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:
- Analyze changes in different areas of women's sexual function in young people with dyspareunia through treatment (Desire, arousal, lubrication, orgasm, satisfaction and pain).
- 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:
- Treatment Group (CRMRF and physical therapy modalities on pelvic floor)
- 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.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Procedure: Physical therapy modalities on pelvic floor (manual therapy), Device: CRMRFCRMRF and physical therapy modalities on pelvic floor. |
| Sham Group | Sham comparator | Procedure: Physical therapy modalities on pelvic floor (manual therapy), Device: Sham CRMRFOnly physical therapy modalities on pelvic floor. In this Arm the CRMRF is off. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women between 18 and 30 years old.
- Women who have pain during sexual intercourse, classified as dyspareunia superficial in the last 12 months.
Key exclusion criteria (8 listed)
- Use of antidepressants.
- Pregnancy and lactation.
- Cardiac pathologies.
- Epilepsy.
- Acute inflammatory process.
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 |
|---|---|---|
| Physical therapy modalities on pelvic floor (manual therapy)Intravaginal treatment (perineal massage) | Procedure or surgery | Sham Group, Treatment Group |
| CRMRFCRMRF 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 | Device | Treatment Group |
| Sham CRMRFThe physical therapist applies the same treatment as the Treatment Group but the device is switched off. | Device | Sham Group |
Primary outcome
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.
5 secondary outcomes
Female sexual function
Time frame: Five months
Quality of sexual relations
Time frame: Five months
Problems with vaginal penetration
Time frame: Five months
State of the musculature of the pelvic floor
Time frame: Five months
Perception of treatment
Time frame: Five months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Results publication: PubMed 29913665Thomten 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.
- Results publication: PubMed 19140047Elmerstig 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.
- Results publication: PubMed 25345486Hendrickx 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.
- Results publication: PubMed 28120373Mitchell 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.
- Results publication: PubMed 26410801Demirel 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.
- Results publication: PubMed 28391147Leon-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.
- Results publication: PubMed 26906970Takeuchi 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.
- Results publication: PubMed 28759286Spottorno 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.
- Results publication: PubMed 28027568Silva 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.
- Results publication: PubMed 26524223Kumaran 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.
- Results publication: PubMed 34135723Trahan 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.
- Results publication: PubMed 32197978Sanchez-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.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Anna Abelló Pla, MSc principal investigator
Escoles Universitaries Gimbernat
Jordi Esquirol Caussa, PhD study director
Escoles Universitaries Gimbernat
Judit Lleberia study director
Universitat Autònoma de Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical therapy modalities on pelvic floor (manual therapy) and CRMRF in people with Dyspareunia; Female, run by Escoles Universitaries Gimbernat at 1 site in Spain.
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 2 inclusion and 8 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: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain in sexual intercourse (time frame: Five months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05844189, which also lists 16 linked publications.
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 May 2023.