EndometriosisPHYSIO_ENDOMNCT06212349
Therapeutic-educational Physiotherapy on Pain, Physical-functionality and Quality of Life in Women With Endometriosis.
A study testing therapeutic-educational physiotherapy and pain education program and pain education program in people with Endometriosis and Chronic Pain, run by University of Valencia at 1 site in Spain.
Trial summary
This is a randomized clinical trial that will be carried out in women with endometriosis divided into two groups: the experimental group (EG) that will receive therapeutic-educational physiotherapy, which will combine therapeutic exercise with a pain education program, and the control group (CG) who will receive the… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis, Chronic Pain, Women's Health
- What is being tested?
- therapeutic-educational physiotherapy and pain education program and pain education program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSpain
- Study dates
- 9 Sep 2024to 22 Dec 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of endometriosis made by imaging techniques (MRI or ultrasound) or by surgery.
- A period of 3 months or more since the last surgery if they have undergone surgery.
- Who are receiving hormone treatment and have their disease under control.
- Persistent pelvic pain for at least 3 months.
- With pain and hypertonus in the pelvic musculature, myofascial syndrome, vestibulodynia or pudendal neuropathy.
- Consent to participate in the study
- Capable of carrying out the follow-up of the study until the final visit.
- Who have audiovisual resources and the internet at their disposal.
Who cannot join
- Women in the menopausal phase
- Women undergoing fertility treatment or planning to undergo fertility treatment in the next 3 months.
- Pregnant women.
- Women undergoing physiotherapy treatment or who have undergone physiotherapy treatment in the last 3 months.
- Having suffered a fracture in the last 3 months in the lower limb that limits their functional capacity.
- Cognitive illness that prevents correct comprehension of the exercises.
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- Musculoskeletal pathology or neuropathy in acute phase.
- Having suffered or suffering from a neoplastic disease.
- Untreated endometriosis
- Acquired genital abnormalities of the pelvis or pelvic floor.
- Women in a situation of litigation or economic compensation, or pending the granting of a degree of disability.
- Severe mental illness (schizophrenia, borderline personality disorder, etc.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari i Politècnic La Fe,
Valencia, 46026
Iren Juarez, MD, 961244000, ijuapa@gmail.com
About this study
Official title: Effect of a Therapeutic-educational Physiotherapy Program on Pain and the Physical-functional Sphere in Women With Endometriosis and Its Impact on Quality of Life
This is a randomized clinical trial that will be carried out in women with endometriosis divided into two groups: the experimental group (EG) that will receive therapeutic-educational physiotherapy, which will combine therapeutic exercise with a pain education program, and the control group (CG) who will receive the pain education program.
The participants will be evaluated at three moments: before starting the study (T1), after the 8-week treatment program (T2) and after another 8 weeks of follow-up in which they will be encouraged to continue with the treatment (T3). The initial assessment will include a medical and physiotherapy history, and at T1, T2 and T3 the following will be assessed: pain, abdominopelvic mobility, muscle status, functionality, sexual function, quality of life, stress and biomarkers of chronic inflammation.
- Conditions
- Endometriosis, Chronic Pain, Women's Health
- Being tested
- therapeutic-educational physiotherapy and pain education program, pain education program
- Keywords
- endometriosis, Chronic Pain, Physical Therapy, Health education, Women
- Medical subject headings
- Endometriosis, Chronic Pain, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic-educational physiotherapy and pain education programOther
The EG will carry out a total of 24 sessions, at a rate of 3 weekly sessions of 30 minutes each. The first session of each month will be in person and the rest will be done at home following video tutorials with an App (https://fisiotrack.com). The face-to-face sessions will be conducted by a women's health physiotherapist, and will consist on therapeutic exercises based on body awareness, motor control and respiratory awareness.They will also receive a pain education program with indications on pain education, as well as basic information and general advice on the positive effects of physical activity and a healthy lifestyle for endometriosis. In addition, biweekly supervision will be carried out via telephone or video conference by a specialized physiotherapist.
pain education programOther
They will receive instructions on pain education, as well as basic information and general advice about the positive effects of physical activity and a healthy lifestyle for your endometriosis, in writing via email. In addition, they will receive biweekly supervision via telephone or video conference by a specialized physical therapist.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | They will receive therapeutic-educational physiotherapy, which will combine therapeutic exercise with a pain education program, Receives: Other: therapeutic-educational physiotherapy and pain education program |
| Control | Other | They will receive the pain education program. Receives: Other: pain education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Musculoskeletal pain - Pressure pain threshold
Pressure pain threshold measured in rectus abdominis and lumbar muscles
Measured: 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
Musculoskeletal pain - quantitative Sensory Testing
Quantitative sensory testing is a non-invasive technique used to assess and quantify sensory functions by determining sensation and pain thresholds using pressure.
Measured: 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
Musculoskeletal pain - pain drawing
Identification of pain areas through a pain map: this consists of a human figure on a two-dimensional plane on which the patient can express the representation of the pain areas on a schematic of the body surface.
Measured: 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
Musculoskeletal pain - Central Sensitisation Inventory
Central Sensitisation Inventory: is a self-report instrument that indirectly assesses somatic and emotional symptoms that have been found to be associated with Central Sensitisation.
Measured: 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
Secondary outcomes (17)
Physical-Funcionality - Hand grip Strength
Hand grip strength will be measured by the handgrip strength technique using a Jamar Plus+ digital hand dynamometer.
Measured: 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
Physical-Funcionality - functional performance
To assess functional performance patients will be instructed to cross their arms over their chest and complete as many standing cycles as possible in 30 s (30 second- Sit to stand).
Measured: 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
Physical-Funcionality- Pelvic floor Dynamometry
Dynamometry of the pelvic floor muscles: measurement of basal tone (g) and tone at maximum contraction (Phenix Liberty Dynamometer).
Measured: 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
Physical-Funcionality - Body composition
Body composition (% fat, % water, % muscle): record body composition (skeletal muscle mass and % body fat) with a bioimpedance scale (DC-430MA, Tanita Corporation of America, Inc, Arlignton Heights, IL, USA).
Measured: 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
Physical-Funcionality - Motor control
Determine motor control: clinical test of lumpopelvic and thoracolumbar dissociation will be used.
Measured: assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
Physical-Funcionality - Lumbar spine flexibility
Lumbar spine flexibility: It will be measured with the Schöber test
Measured: assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
Physical-Funcionality - Catastrophyzing
Catastrophyzing: to assess catastrophic thinking related to pain the Pain Catastrophyzing Scale (PCS) will be used
Measured: assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
Physical-Funcionality - Kinesophobia
Kinesophobia: it will be assessed with the Tampa Scale for Kinesophobia-11 (TSK-11), which consists of 11 items.
Measured: assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
Quality of Life - Endometriosis
Quality of life will be assessed using the Spanish version of the Endometriosis Health Profile-30 (EHP-30).
Measured: assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
Quality of Life - Gastrointestinal
Quality of life at the gastrointestinal level will be assessed using the Gastrointestinal Quality of Life Index, which addresses 5 domains (digestive symptoms, physical state, emotions, social dysfunction and effects of medical treatment).
Measured: assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
Quality of Life - Sexual Function
the abbreviated Index of Female Sexual Function (IFSF-6) will be used. It is a multidimensional self-reported instrument for the evaluation of female sexual function
Measured: assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
Quality of Life - Stress
Stress using the Perceived stress scale (PSQ).
Measured: assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
Biomarkers - Inflamation
Plasma markers of chronic inflammation and intestinal permeability will be assessed including a multiplex array of inflammation markers, and as specific markers of chronic inflammation associated with intestinal permeability, zonulin, C-reactive protein, Binding Protein , and bactericidal/permeability-increasing protein will be assessed.
Measured: assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
Patient's satisfaction
Satisfaction with the treatment received will be assessed using the Satisfaction with Treatment Received Scale (CRES-4).
Measured: assessent times: T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
Patient's perception of change
Patient's Perception of change after the treatment will be measured by patients' global impression of change (PGIC) in a quantitative and qualitative way.
Measured: assessent times: T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
APP usability
A questionnaire on the usability of the application will be used. System Usability Scale.
Measured: assessent times: T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
Adherence to treatment
Adherence to treatment: in the experimental group it will be measured through the records made in the application https://fisiotrack.com/, in the control group it will be measured through an ad hoc activity diary that will be provided to them.
Measured: assessent times: T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start9 Sep 2024
- Primary completion9 Sep 2027 (estimated)
- Study completion22 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario La Fe, Instituto de Investigacion Sanitaria La Fe
- Responsible party
- Principal investigator, Laura Fuentes Aparicio, University of Valencia
- Investigators
- laura Fuentes Aparicio, PhD, Principal investigator, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06212349
- Sponsor's protocol ID
- UV_Dep_FISIO
- Acronym
- PHYSIO_ENDOM
- Status last verified
- May 2026
- First submitted
- 8 Jan 2024
- Last updated
- 19 May 2026
- 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 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Therapeutic-educational Physiotherapy Program on Pain and the Physical-functional Sphere in Women With Endometriosis and Its Impact on Quality of Life
- ClinicalTrials.gov ID
- NCT06212349
- Acronym / sponsor ID
- PHYSIO_ENDOM / UV_Dep_FISIO
- Conditions
- Endometriosis, Chronic Pain, Women's Health
- Keywords
- endometriosis, Chronic Pain, Physical Therapy, Health education, Women
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- Hospital Universitario La Fe, Instituto de Investigacion Sanitaria La Fe
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- 9 Sep 2027 (estimated)
- Study completion
- 22 Dec 2027 (estimated)
- First posted
- 18 Jan 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 is a randomized clinical trial that will be carried out in women with endometriosis divided into two groups: the experimental group (EG) that will receive therapeutic-educational physiotherapy, which will combine therapeutic exercise with a pain education program, and the control group (CG) who will receive the pain education program.
The participants will be evaluated at three moments: before starting the study (T1), after the 8-week treatment program (T2) and after another 8 weeks of follow-up in which they will be encouraged to continue with the treatment (T3). The initial assessment will include a medical and physiotherapy history, and at T1, T2 and T3 the following will be assessed: pain, abdominopelvic mobility, muscle status, functionality, sexual function, quality of life, stress and biomarkers of chronic inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: therapeutic-educational physiotherapy and pain education programThey will receive therapeutic-educational physiotherapy, which will combine therapeutic exercise with a pain education program, |
| Control | Other | Other: pain education programThey will receive the pain education program. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Diagnosis of endometriosis made by imaging techniques (MRI or ultrasound) or by surgery.
- A period of 3 months or more since the last surgery if they have undergone surgery.
- Who are receiving hormone treatment and have their disease under control.
- Persistent pelvic pain for at least 3 months.
- With pain and hypertonus in the pelvic musculature, myofascial syndrome, vestibulodynia or pudendal neuropathy.
Key exclusion criteria (12 listed)
- Women in the menopausal phase
- Women undergoing fertility treatment or planning to undergo fertility treatment in the next 3 months.
- Pregnant women.
- Women undergoing physiotherapy treatment or who have undergone physiotherapy treatment in the last 3 months.
- Having suffered a fracture in the last 3 months in the lower limb that limits their functional capacity.
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 |
|---|---|---|
| therapeutic-educational physiotherapy and pain education programThe EG will carry out a total of 24 sessions, at a rate of 3 weekly sessions of 30 minutes each. The first session of each month will be in person and the rest will be done at home following video tutorials with an App (https://fisiotrack.com). The face-to-face sessions will be conducted by a women's health physiotherapist, and will consist on therapeutic exercises based on body awareness, motor control and respiratory awareness.They will also receive a pain education program with indications on pain education, as well as basic information and general advice on the positive effects of physical activity and a healthy lifestyle for endometriosis. In addition, biweekly supervision will be carried out via telephone or video conference by a specialized physiotherapist. | Other | Experimental |
| pain education programThey will receive instructions on pain education, as well as basic information and general advice about the positive effects of physical activity and a healthy lifestyle for your endometriosis, in writing via email. In addition, they will receive biweekly supervision via telephone or video conference by a specialized physical therapist. | Other | Control |
Primary outcome
Musculoskeletal pain - Pressure pain threshold
Time frame: 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
Pressure pain threshold measured in rectus abdominis and lumbar muscles
Musculoskeletal pain - quantitative Sensory Testing
Time frame: 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
Quantitative sensory testing is a non-invasive technique used to assess and quantify sensory functions by determining sensation and pain thresholds using pressure.
Musculoskeletal pain - pain drawing
Time frame: 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
Identification of pain areas through a pain map: this consists of a human figure on a two-dimensional plane on which the patient can express the representation of the pain areas on a schematic of the body surface.
Musculoskeletal pain - Central Sensitisation Inventory
Time frame: 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
Central Sensitisation Inventory: is a self-report instrument that indirectly assesses somatic and emotional symptoms that have been found to be associated with Central Sensitisation.
17 secondary outcomes
Physical-Funcionality - Hand grip Strength
Time frame: 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
Physical-Funcionality - functional performance
Time frame: 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
Physical-Funcionality- Pelvic floor Dynamometry
Time frame: 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
Physical-Funcionality - Body composition
Time frame: 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
Physical-Funcionality - Motor control
Time frame: assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
Physical-Funcionality - Lumbar spine flexibility
Time frame: assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
Physical-Funcionality - Catastrophyzing
Time frame: assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
Physical-Funcionality - Kinesophobia
Time frame: assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
Quality of Life - Endometriosis
Time frame: assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
Quality of Life - Gastrointestinal
Time frame: assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
Quality of Life - Sexual Function
Time frame: assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
Quality of Life - Stress
Time frame: assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
Biomarkers - Inflamation
Time frame: assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
Patient's satisfaction
Time frame: assessent times: T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
Patient's perception of change
Time frame: assessent times: T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
APP usability
Time frame: assessent times: T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
Adherence to treatment
Time frame: assessent times: T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)
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 19 May 2026.
- 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.
laura Fuentes Aparicio, PhD principal investigator
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing therapeutic-educational physiotherapy and pain education program and pain education program in people with Endometriosis and Chronic Pain, run by University of Valencia 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 8 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 19 May 2026. 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?
Contact Irene Juarez, MD (961244000, ijuapa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Musculoskeletal pain - Pressure pain threshold (time frame: 3 assessent times: T1(pre-intervention), T2 (after 8 weeks intervention), T3 (after 16 weeks intervention)). The study lists 4 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 19 May 2026.