ClinicalTrials.gg
Active, not recruitingNCT06614465Updated May 22, 2025

Multimodal Rehabilitation Programme on Epigenetic Biomarkers, Quality of Life, Sexual Function and Muscle Strength in Women With Dyspareunia and Endometriosis.

An interventional study of Multimodal Rehabilitation in Multidisciplinary Communication, sponsored by Clínica INEBIR. Active, not recruiting at 1 site in Spain. Open to female participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2025-05-22.

Sponsored by Clínica INEBIR · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Jan 2026, 9 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
126
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 42 studies in Endometriosis with a site in Spain — 13 open to participants now, 15 under way, none of them phase 3. Endometriosis · Spain.

Planned enrollment
11th of 33
126 · median 90
Started
2025
with 5 others
No phase
18 of 42
8 open now
Primary completion
2026-01
later than 3 of 14 live
Registered
33rd of 42
by date

Among the 42 studies in Endometriosis with a site in Spain, this one is the 11th largest by planned enrollment of the 33 interventional ones that give a count, is one of 6 that started in 2025, is one of 18 with no phase, reaches primary completion later than 3 of the 14 other live ones, and was the 33rd registered.

Endometriosis

920 studies on the registry are indexed under Endometriosis; 266 are open to participants now.

Browse Endometriosis studies →

Open to participants now

13 of the 42 studies in Endometriosis with a site in Spain are open now. Recruiting first, the newest first:

8 more — sign in →

All 13 open studies →

A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →

Who these studies take

Of the 176 Endometriosis studies recruiting now, 51 (29%) set no upper age limit and 123 (70%) stop at 75 or younger; 18 take children under 18; 39 take healthy volunteers.

This study: 18 Years to 55 Years · female · no healthy volunteers.

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02

Study 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 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).

03

Conditions studied

  • Multidisciplinary Communication

Keywords

  • Endometriosis
  • Dyspareunia
  • Multimodal Rehabilitation
  • Epigenetic Biomarkers
  • Quality of life
  • Sexual Function
  • Muscle Strength
04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • A neurological, oncological or 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
126 participants (estimated)

Study arms

  • Experimental
    1.Experimental Group

    The intervention group will receive a multimodal rehabilitation programme including therapeutic exercise, health education and manual therapy.

    Other: Multimodal Rehabilitation

  • No intervention
    2.Control Group

    The control group will not receive this intervention.

Interventions

  • OtherMultimodal Rehabilitation

    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.

06

What researchers measure

Primary outcomes

  1. miR-21

    miR-21 levels in saliva

    Time frame: 1 month

  2. Quality of life

    will be measured with the The Short Form-36 Health Survey (SF-36). A higher score indicates better health status.

    Time frame: 1 month

  3. Sexual Function

    Will be measured with the Female Sexual Function Index (FSFI) questionnaire. A higher score indicates better sexual function.

    Time frame: 1 month

  4. Pelvic Floor Muscle Strength

    Will be measured with Oxford and Perfect scale. A higher score indicates better Muscle Strength status.

    Time frame: 1 month

  5. Pain

    Will be measured with Brief Pain Inventory (BPI) Questionnaire. A higher score indicates worse health status.

    Time frame: 1 month

Secondary outcomes

  1. Systemic inflammation

    Will be measured with polymerase chain reaction (PCR).

    Time frame: 1 month

  2. Hormone Levels

    Will be measured with blood test.

    Time frame: 1 month

  3. Psychological condition

    Will be measured with Hospital Anxiety and Depression Scale (HADS). A higher score indicates worse health status.

    Time frame: 1 month

  4. 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.

    Time frame: 1 month

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2025 (actual). Primary completion is estimated for Jan 2026, 12 months after the start.

Of 196 non-industry interventional studies with no phase under Endometriosis, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 44. This study's planned 12 months is below that.

Counting every sponsor, half of 211 studies reached it within 25 months; a quarter within 13 and three quarters within 44.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 24, 2024
First posted
Sep 26, 2024
StartActual
Jan 8, 2025
Primary completionEst.
Jan 31, 2026
CompletionEst.
Jan 31, 2027
Last update
May 22, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06614465
Lead sponsor
Clínica INEBIR
Responsible party
Sponsor
First posted
Sep 26, 2024
Start date
Jan 8, 2025
Primary completion
Jan 31, 2026 (estimated)
Completion
Jan 31, 2027 (estimated)
Last update
May 22, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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