Multidisciplinary CommunicationNCT06614465
Multimodal Rehabilitation Programme on Epigenetic Biomarkers, Quality of Life, Sexual Function and Muscle Strength in Women With Dyspareunia and Endometriosis.
A study testing Multimodal Rehabilitation in people with Multidisciplinary Communication, run by Clínica INEBIR at 1 site in Spain.
Trial summary
This study aims to evaluate the impact of a multimodal rehabilitation programme on epigenetic biomarkers in blood, quality of life, sexual function and pelvic floor muscle strength and endurance in women with dyspareunia and endometriosis. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Multidisciplinary Communication
- What is being tested?
- Multimodal Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteSpain
- Study dates
- 8 Jan 2025to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women diagnosed with endometriosis
- Women with dyspareunia and chronic pelvic pain
- Ability to communicate fluently verbally and in writing in the language of the research team, in this case Spanish.
- Approval to participate in the study by your regular gynaecologist who is part of your diagnosis and treatment.
Who cannot join
- A neurological, oncological or autoimmune disease that prevents the participant from performing exercise.
- Any type of pathology that prevents the participant from performing exercise.
- A diagnosis of severe psychiatric or neurological disorders that do not allow the participant to follow orders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of a Multimodal Rehabilitation Programme on Epigenetic Biomarkers, Quality of Life, Sexual Function and Muscle Strength in Women With Dyspareunia and Endometriosis: Protocol for a Randomised Controlled Trial.
This study aims to evaluate the impact of a multimodal rehabilitation programme on epigenetic biomarkers in blood, quality of life, sexual function and pelvic floor muscle strength and endurance in women with dyspareunia and endometriosis.
Read the detailed description
Introduction: Endometriosis is a benign gynaecological disease that affects approximately 10% of women of childbearing age, causing chronic pelvic pain and profound dyspareunia, which significantly impairs quality of life. This study aims to evaluate the impact of a multimodal rehabilitation programme on epigenetic biomarkers, quality of life, sexual function and muscle strength in women with dyspareunia and endometriosis.
Study Design: Pilot of Randomised controlled clinical trial according to CONSORT and TIDieR guidelines. The study will run from January 2025 to January 2026.
Inclusion criteria: Women between 18 and 55 years old, diagnosed with endometriosis with dyspareunia and chronic pelvic pain, with the ability to communicate in Spanish, and approval of their gynaecologist.
Exclusion criteria: Neurological, oncological, autoimmune or serious psychiatric diseases that prevent exercise or manual therapy.
Sample Size: 20 women diagnosed with dyspareunia and endometriosis, randomly divided into two groups: 10 in the intervention group and 10 in the control group.
Intervention: The intervention group will receive a multimodal rehabilitation programme including therapeutic exercise, health education and manual therapy. The control group will not receive this intervention.
Primary results: Measurements will be taken at four key points in time: baseline (T0), 2 months (T1), 6 months (T2) and 12 months (T3). To assess the effect of the intervention on miR-21 levels in saliva, quality of life (SF-36 questionnaire), sexual function (FSFI), pain, and pelvic floor muscle strength (measured with Oxford and Perfect scales).
Second Results: Measurement of systemic inflammation by CRP and IL-6, hormone levels (oestrogen and progesterone), stress and psychological well-being (HADS), muscle strength (EPI-NO), adherence to treatment and satisfaction with the intervention.
Ethics and Privacy: The study will have the approval of the Ethics Committee of the University of Pablo de Olavide, following the Declaration of Helsinki and Spanish regulations (Law 14/2007 on Biomedical Research). Participants will sign an informed consent form, and the data will be managed in accordance with the Spanish Data Protection Act (Law 3/2018).
- Conditions
- Multidisciplinary Communication
- Being tested
- Multimodal Rehabilitation
- Keywords
- Endometriosis, Dyspareunia, Multimodal Rehabilitation, Epigenetic Biomarkers, Quality of life, Sexual Function, Muscle Strength
- Medical subject headings
- Endometriosis, Dyspareunia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal RehabilitationOther
The intervention will consist of 4 sessions of education in pain neuroscience, 4 sessions of therapeutic exercise and 4 sessions of manual therapy in the abdominopelvic area.
| Study group | Role | What they receive |
|---|---|---|
| 1.Experimental Group | Experimental | The intervention group will receive a multimodal rehabilitation programme including therapeutic exercise, health education and manual therapy. Receives: Other: Multimodal Rehabilitation |
| 2.Control Group | No intervention | The control group will not receive this intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
miR-21
miR-21 levels in saliva
Measured: 1 month
Quality of life
will be measured with the The Short Form-36 Health Survey (SF-36). A higher score indicates better health status.
Measured: 1 month
Sexual Function
Will be measured with the Female Sexual Function Index (FSFI) questionnaire. A higher score indicates better sexual function.
Measured: 1 month
Pelvic Floor Muscle Strength
Will be measured with Oxford and Perfect scale. A higher score indicates better Muscle Strength status.
Measured: 1 month
Pain
Will be measured with Brief Pain Inventory (BPI) Questionnaire. A higher score indicates worse health status.
Measured: 1 month
Secondary outcomes (4)
Systemic inflammation
Will be measured with polymerase chain reaction (PCR).
Measured: 1 month
Hormone Levels
Will be measured with blood test.
Measured: 1 month
Psychological condition
Will be measured with Hospital Anxiety and Depression Scale (HADS). A higher score indicates worse health status.
Measured: 1 month
satisfaction with the intervention
Will be measured with MedRisk questionnaire. The MedRisk Instrument for Measuring Patient Satisfaction With Physical Therapy Care. A higher score indicates greater disability or more pain.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start8 Jan 2025
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multidisciplinary CommunicationStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clínica INEBIR
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06614465
- Sponsor's protocol ID
- Endometriosis and dyspareunia
- Status last verified
- May 2025
- First submitted
- 24 Sep 2024
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Multimodal Rehabilitation Programme on Epigenetic Biomarkers, Quality of Life, Sexual Function and Muscle Strength in Women With Dyspareunia and Endometriosis: Protocol for a Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT06614465
- Acronym / sponsor ID
- Endometriosis and dyspareunia
- Conditions
- Multidisciplinary Communication
- Keywords
- Endometriosis, Dyspareunia, Multimodal Rehabilitation, Epigenetic Biomarkers, Quality of life, Sexual Function, Muscle Strength
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Clínica INEBIRUniversity, hospital or other
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 26 Sep 2024 (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.
This study aims to evaluate the impact of a multimodal rehabilitation programme on epigenetic biomarkers in blood, quality of life, sexual function and pelvic floor muscle strength and endurance in women with dyspareunia and endometriosis.
Detailed description
Introduction: Endometriosis is a benign gynaecological disease that affects approximately 10% of women of childbearing age, causing chronic pelvic pain and profound dyspareunia, which significantly impairs quality of life. This study aims to evaluate the impact of a multimodal rehabilitation programme on epigenetic biomarkers, quality of life, sexual function and muscle strength in women with dyspareunia and endometriosis.
Study Design: Pilot of Randomised controlled clinical trial according to CONSORT and TIDieR guidelines. The study will run from January 2025 to January 2026.
Inclusion criteria: Women between 18 and 55 years old, diagnosed with endometriosis with dyspareunia and chronic pelvic pain, with the ability to communicate in Spanish, and approval of their gynaecologist.
Exclusion criteria: Neurological, oncological, autoimmune or serious psychiatric diseases that prevent exercise or manual therapy.
Sample Size: 20 women diagnosed with dyspareunia and endometriosis, randomly divided into two groups: 10 in the intervention group and 10 in the control group.
Intervention: The intervention group will receive a multimodal rehabilitation programme including therapeutic exercise, health education and manual therapy. The control group will not receive this intervention.
Primary results: Measurements will be taken at four key points in time: baseline (T0), 2 months (T1), 6 months (T2) and 12 months (T3). To assess the effect of the intervention on miR-21 levels in saliva, quality of life (SF-36 questionnaire), sexual function (FSFI), pain, and pelvic floor muscle strength (measured with Oxford and Perfect scales).
Second Results: Measurement of systemic inflammation by CRP and IL-6, hormone levels (oestrogen and progesterone), stress and psychological well-being (HADS), muscle strength (EPI-NO), adherence to treatment and satisfaction with the intervention.
Ethics and Privacy: The study will have the approval of the Ethics Committee of the University of Pablo de Olavide, following the Declaration of Helsinki and Spanish regulations (Law 14/2007 on Biomedical Research). Participants will sign an informed consent form, and the data will be managed in accordance with the Spanish Data Protection Act (Law 3/2018).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1.Experimental Group | Experimental | Other: Multimodal RehabilitationThe intervention group will receive a multimodal rehabilitation programme including therapeutic exercise, health education and manual therapy. |
| 2.Control Group | No intervention | –The control group will not receive this intervention. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women diagnosed with endometriosis
- Women with dyspareunia and chronic pelvic pain
- Ability to communicate fluently verbally and in writing in the language of the research team, in this case Spanish.
- Approval to participate in the study by your regular gynaecologist who is part of your diagnosis and treatment.
Key exclusion criteria (3 listed)
- A neurological, oncological or autoimmune disease that prevents the participant from performing exercise.
- Any type of pathology that prevents the participant from performing exercise.
- A diagnosis of severe psychiatric or neurological disorders that do not allow the participant to follow orders.
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 |
|---|---|---|
| Multimodal RehabilitationThe intervention will consist of 4 sessions of education in pain neuroscience, 4 sessions of therapeutic exercise and 4 sessions of manual therapy in the abdominopelvic area. | Other | 1.Experimental Group |
Primary outcome
miR-21
Time frame: 1 month
miR-21 levels in saliva
Quality of life
Time frame: 1 month
will be measured with the The Short Form-36 Health Survey (SF-36). A higher score indicates better health status.
Sexual Function
Time frame: 1 month
Will be measured with the Female Sexual Function Index (FSFI) questionnaire. A higher score indicates better sexual function.
Pelvic Floor Muscle Strength
Time frame: 1 month
Will be measured with Oxford and Perfect scale. A higher score indicates better Muscle Strength status.
Pain
Time frame: 1 month
Will be measured with Brief Pain Inventory (BPI) Questionnaire. A higher score indicates worse health status.
4 secondary outcomes
Systemic inflammation
Time frame: 1 month
Hormone Levels
Time frame: 1 month
Psychological condition
Time frame: 1 month
satisfaction with the intervention
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Rehabilitation in people with Multidisciplinary Communication, run by Clínica INEBIR 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 4 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 22 May 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
miR-21 (time frame: 1 month). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.