- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07658703
Physiotherapeutic Approach to Superficial and Deep Dyspareunia in Women With Chronic Pelvic Pain: Comparison Between In-person and Telehealth Care.
June 16, 2026 updated by: Hellen Maria Feitoza De Almeida, University of Sao Paulo
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
72
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
São Paulo
-
Ribeirão Preto, São Paulo, Brazil, 14048-900
- Ribeirão Preto Clinical Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- Women with penetrative dyspareunia without pelvic floor muscle spasm;
- Women without an active sex life
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Face-to-face treatment
Treatment through face-to-face outpatient care
|
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.
|
|
Active Comparator: Telecare
Teleservice via video call
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale (EAV)
Time Frame: From acceptance to participate in the study until the end in 10 weeks in the reassessment.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 16, 2025
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
January 1, 2028
Study Registration Dates
First Submitted
May 23, 2026
First Submitted That Met QC Criteria
June 16, 2026
First Posted (Actual)
June 22, 2026
Study Record Updates
Last Update Posted (Actual)
June 22, 2026
Last Update Submitted That Met QC Criteria
June 16, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Mental Disorders
- Genital Diseases, Male
- Male Urogenital Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Genital Diseases, Female
- Sexual Dysfunction, Physiological
- Sexual Dysfunctions, Psychological
- Dyspareunia
- Health Services Administration
- Delivery of Health Care
- Patient Care Management
- Telemedicine
Other Study ID Numbers
- 7.460.314
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All IPR collected, all IPR that underpins the results of a publication.
IPD Sharing Time Frame
July 2025-January 2028
IPD Sharing Access Criteria
Researchers who conduct studies on chronic pelvic pain
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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