EndometriosisNCT05679063
Therapeutic Exercise and Education in Neurophysiology of Pain in the Quality of Life of Women With Endometriosis
A study testing Physiotherapy in people with Endometriosis, run by University of Valladolid at 1 site in Spain.
Trial summary
The objective of this study will be to evaluate treatment using ET exercise and pain education in women with endometriosis to achieve improvement in quality of life. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Physiotherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 29 Dec 2022to 1 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Women of reproductive age between 18 and 45 years.
- Women with a medical diagnosis of endometriosis.
- Women with visual analog scale (EVA) between 4 and 10 (moderate-severe pain) during the last 3 months in the suprapubic area, abdomen or perineum both continuously and intermittently.
Who cannot join
- Women who must have surgery during the study.
- Women who have undergone abdominal or pelvic surgery or who have given birth (vaginal or cesarean) in the last 6 months.
- Women who are pregnant or planning a pregnancy.
- Women with uncorrected pacemakers or coagulopathies, severe comorbid disorder, cancer (in the last 5 years or at present), severe mental disorders, or neuropathies affecting the nerves of the pelvis or lower extremities.
- Physiotherapy treatments or treatments related to pathology or study areas 15 days prior to the beginning of the study.
- Variations in medication in the 3 months prior to the start of the stud
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Therapeutic Exercise and Education in Neurophysiology of Pain in the Quality of Life of Women With Endometriosis: Clinical Trial
The objective of this study will be to evaluate treatment using ET exercise and pain education in women with endometriosis to achieve improvement in quality of life.
Read the detailed description
A study will be carried out whose objective is to improve the quality of life in women with endometriosis through a program of therapeutic exercise and education in the neurophysiology of pain. Also as secondary variables will be observed: menstrual symptoms, sexual function, and abdominal wall thickness measured with ultrasound.
- Conditions
- Endometriosis
- Being tested
- Physiotherapy, Sham, Control
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhysiotherapyOther
A program of therapeutic exercise and education in the neurophysiology of pain will be applied to the participants of the experimental group
Sham, ControlOther
Talks about healthy habits
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Exercise and Pain Neurophysiology Education | Experimental | Therapeutic exercise is the systematic and planned execution of posture movements and physical activities to correct or prevent alterations, improve or enhance physical functioning, and prevent risk factors for solid and optimized overall health status.
Pain Neurophysiology Education:
Education in pain neurophysiology consists in describing to the patient the neurobiology and neurophysiology of his nervous system pain to improve the processing of it and decrease the threatening meaning of pain. Receives: Other: Physiotherapy |
| Sham Comparator | Sham comparator | Talks about healthy habits Receives: Other: Sham, Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in quality of life perception assessed using EUROQuOL 5D - 5L
The scale will be administered by one of the researchers, This scale covers five dimensions, each of which is assigned a score from 1 to 5, and with these scores, a code is obtained that indicates the person's quality of life. High values indicate poor quality of life.
Measured: Baseline, Up to 1 month, Up to 3 months.
Secondary outcomes (3)
Abdominal wall muscle thickness
The muscle thickness of the abdominal wall with ultrasound according to a defined protocol.
Measured: Baseline, Up to 1 month, Up to 3 months
Sexual Function assessed usinf Female Sexual Function Index (IFSF)
The scale will be administered by one of the researchers. This questionnaire consists of 19 questions and is grouped into six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain; each question has 5 or 6 options, assigning them a score ranging from 0 to 5. The score for each domain is multiplied by a factor and the result final is the arithmetic sum of the domains. A higher score better sexuality
Measured: Baseline, Up to 1 month, Up to 3 months
Symptoms associated with menstruation assessed using CVM-22 (quality of life related to menstruation)
The scale will be administered by one of the researchers. Minimin value = 0. Maximum value = 66. A high result indicates a good quality of life-related to menstruation
Measured: Baseline, up to 1 month, up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start29 Dec 2022
- Primary completion12 Oct 2024
- Study completion1 May 2025
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
- Model description
- Trough a randomization program, participants will be assigned to the treatment group or the control group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valladolid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebeca Abril Coello, University of Valladolid
- Investigators
- SANDRA JIMENEZ, Doctor, Study director, University of Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679063
- Sponsor's protocol ID
- EndometriosisCdV2022
- Status last verified
- May 2025
- First submitted
- 28 Dec 2022
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Exercise and Education in Neurophysiology of Pain in the Quality of Life of Women With Endometriosis: Clinical Trial
- ClinicalTrials.gov ID
- NCT05679063
- Acronym / sponsor ID
- EndometriosisCdV2022
- Conditions
- Endometriosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ValladolidUniversity, hospital or other
- Study start
- 29 Dec 2022 (actual)
- Primary completion
- 12 Oct 2024 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 10 Jan 2023 (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.
The objective of this study will be to evaluate treatment using ET exercise and pain education in women with endometriosis to achieve improvement in quality of life.
Detailed description
A study will be carried out whose objective is to improve the quality of life in women with endometriosis through a program of therapeutic exercise and education in the neurophysiology of pain. Also as secondary variables will be observed: menstrual symptoms, sexual function, and abdominal wall thickness measured with ultrasound.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Trough a randomization program, participants will be assigned to the treatment group or the control group.
| Arm | Type | Receives |
|---|---|---|
| Therapeutic Exercise and Pain Neurophysiology Education | Experimental | Other: PhysiotherapyTherapeutic exercise is the systematic and planned execution of posture movements and physical activities to correct or prevent alterations, improve or enhance physical functioning, and prevent risk factors for solid and optimized overall health status. Pain Neurophysiology Education: Education in pain neurophysiology consists in describing to the patient the neurobiology and neurophysiology of his nervous system pain to improve the processing of it and decrease the threatening meaning of pain. |
| Sham Comparator | Sham comparator | Other: Sham, ControlTalks about healthy habits |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women of reproductive age between 18 and 45 years.
- Women with a medical diagnosis of endometriosis.
- Women with visual analog scale (EVA) between 4 and 10 (moderate-severe pain) during the last 3 months in the suprapubic area, abdomen or perineum both continuously and intermittently.
Key exclusion criteria (6 listed)
- Women who must have surgery during the study.
- Women who have undergone abdominal or pelvic surgery or who have given birth (vaginal or cesarean) in the last 6 months.
- Women who are pregnant or planning a pregnancy.
- Women with uncorrected pacemakers or coagulopathies, severe comorbid disorder, cancer (in the last 5 years or at present), severe mental disorders, or neuropathies affecting the nerves of the pelvis or lower extremities.
- Physiotherapy treatments or treatments related to pathology or study areas 15 days prior to the beginning of the study.
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 |
|---|---|---|
| PhysiotherapyA program of therapeutic exercise and education in the neurophysiology of pain will be applied to the participants of the experimental group | Other | Therapeutic Exercise and Pain Neurophysiology Education |
| Sham, ControlTalks about healthy habits | Other | Sham Comparator |
Primary outcome
Changes in quality of life perception assessed using EUROQuOL 5D - 5L
Time frame: Baseline, Up to 1 month, Up to 3 months.
The scale will be administered by one of the researchers, This scale covers five dimensions, each of which is assigned a score from 1 to 5, and with these scores, a code is obtained that indicates the person's quality of life. High values indicate poor quality of life.
3 secondary outcomes
Abdominal wall muscle thickness
Time frame: Baseline, Up to 1 month, Up to 3 months
Sexual Function assessed usinf Female Sexual Function Index (IFSF)
Time frame: Baseline, Up to 1 month, Up to 3 months
Symptoms associated with menstruation assessed using CVM-22 (quality of life related to menstruation)
Time frame: Baseline, up to 1 month, up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
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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.
SANDRA JIMENEZ, Doctor study director
University of Valladolid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy in people with Endometriosis, run by University of Valladolid 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 4 Jun 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in quality of life perception assessed using EUROQuOL 5D - 5L (time frame: Baseline, Up to 1 month, Up to 3 months.). 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 4 Jun 2025.