Physiotherapeutic Approach to Superficial and Deep Dyspareunia in Women With Chronic Pelvic Pain: Comparison Between In-person and Telehealth Care.

NCT07658703 | Active Not Recruiting DMC

• 1 other identifier: 7.460.314
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Adequate sexual function is considered an important factor in satisfaction and overall quality of life for both men and women. It is estimated 16% to 40% of women suffer from some form of sexual dysfunction, which is currently considered a public health problem and its investigation is recommended because it causes significant changes in the quality of life of these women. Among the painful disorders, genitopelvic pain, which includes dyspareunia, vaginismus and vulvodynia, dyspareunia stands out, which involves the appearance of pain during or after sexual intercourse, directly affecting physical health, as well as sexual and mental well-being. Among the treatment techniques for dyspareunia in women with chronic pelvic pain, there is the Thiele massage, which provides an inhibitory effect on muscle tension caused by spasms, relaxing, stretching and relieving coital pain. In this sense, we know that physiotherapy treatment has an important role in improving pain symptoms, since musculoskeletal dysfunction may be present in women with dyspareunia, which makes it relevant to verify whether the approach via telecare would have the same effectiveness as the in-person technique that has scientific proof, since through telecare the woman would not be exposed to the risks that are inherent to going to an outpatient clinic, it could cover more women and this would also bring a greater cost-benefit to the unified health system.

Conditions

Surface and Deep Dyspareunia

Keywords

Dyspareunia; Chronic pelvic pain; Telecare; Physiotherapy; Massage

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (EAV)

  The visual analog scale (VAS) for pain is the most widely used unidimensional scale in clinical practice due to its feasibility, speed, and clinical application. It measures pain from 0 to 10, with higher scores indicating greater pain.

  From acceptance to participate in the study until the end in 10 weeks in the reassessment.

Study Arms (2)

Face-to-face treatment

ACTIVE COMPARATOR

Treatment through face-to-face outpatient care

Procedure: Face-to-face treatment

Telecare

ACTIVE COMPARATOR

Teleservice via video call

Procedure: Telecare

Interventions

Face-to-face treatment PROCEDURE

Massage in the direction of the muscle fibers with a pressure tolerable for the patient for 5 minutes. The treatment will be carried out in the outpatient clinic by a previously trained physiotherapist.

Face-to-face treatment

Telecare PROCEDURE

Massage in the direction of the muscle fibers with a pressure tolerable for the patient for 5 minutes. The treatment will be carried out by the patient at home and guided by a previously trained physiotherapist via teleconsultation.

Telecare

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Cisgender women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women diagnosed with CPP and deep or shallow penetration dyspareunia;
• Over 18 years of age;
• Willingness to voluntarily participate in the study, accepting randomization to either of the two treatment arms;
• Signature of the Free and Informed Consent Form (FICF).

You may not qualify if:

• Women with penetrative dyspareunia without pelvic floor muscle spasm;
• Women without an active sex life

Sponsors & Collaborators

• University of Sao Paulo: lead
• University of Sao Paulo General Hospital: collaborator

Study Sites (1)

Ribeirão Preto Clinical Hospital

Ribeirão Preto, São Paulo, 14048-900, Brazil

Location

Related Links

• Plataforma Brasil is the one that approves the research of the ethics and research committee

MeSH Terms

Conditions

Dyspareunia

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 23, 2026
• First Posted: June 22, 2026
• Study Start: May 16, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2028
• Last Updated: June 22, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: July 2025-January 2028
• Access Criteria: Researchers who conduct studies on chronic pelvic pain

Locations

BR (1)