EndometriosisNCT05682235
Therapeutic Exercise and Education in Pain Neurophysiology to Improve Pain Intensity in Women With Endometriosis. Clinical Trial.
A study testing Therapeutic exercise AND pain neurophysiology education 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 improve pain intensity. 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?
- Therapeutic exercise AND pain neurophysiology education
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 12 Dec 2022to 12 Mar 2025
- 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
- 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 study.
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this study will be to evaluate treatment using ET exercise and pain education in women with endometriosis to improve pain intensity.
Read the detailed description
A study will be carried out whose objective is to improve the intensity of pain in women with endometriosis through a program of therapeutic exercise and education in the neurophysiology of pain. Also as secondary variables will be observed: kinesiophobia, catastrophism and impression of global improvement with treatment.
- Conditions
- Endometriosis
- Being tested
- Therapeutic exercise AND pain neurophysiology education, Sham
- Keywords
- Pain, Quality of life, Chronic pelvic pain, therapeutic exercise, pain neurophysiology, physiotherapy
- Medical subject headings
- Endometriosis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic exercise AND pain neurophysiology educationOther
A program of therapeutic exercise and education in the neurophysiology of pain will be applied to the participants of the experimental group and talks on healthy habits to the placebo group participants.
ShamOther
Talk about healthy habits
| Study group | Role | What they receive |
|---|---|---|
| Therapeutic Exercise AND Pain Neurophysiology Education | Experimental | Therapeutic exercise:
Therapeutic exercise is the systematic and planned execution of posture movements and physical activities to correct or prevent alterations, improve or enhance physical functioning, prevent risk factors for solid and optimize 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 diminish the threatening meaning of pain. Receives: Other: Therapeutic exercise AND pain neurophysiology education |
| Sham Comparator | Sham comparator | Talks about healthy habits Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pain perception assessed using a 100mm Visual Analogue Scale (VAS)
The scale will be administered by one of the researchers. Minimum value 0. Maximum value 100. Higher score = Higher level of pain. Lowe and lower scores mean a better result.
Measured: Baseline, Up to 1 month, Up to 3 months
Secondary outcomes (3)
Changes in Kinesiofobia assessed using the Tampa Scale of Kinesiofobia (TSK)
The scale will be administered by one of the researchers. Minimum value 11. Maximum value 44. Higher score = Higher level of kinesiophobia. Lower and lower scores mean better results.
Measured: Baseline, Up to 1 month, Up to 3 months
Changes in Catastrophism assesed using the Pain Catastrophism Scale (PCS)
The scale will be administered by one of the researchers. Minimum value 0. Maximum value 52. Higher score = Higher level of catastrophism. Lower and lower scores mean better results.
Measured: Baseline, Up to 1 month, Up to 3 months
Impression of the overall improvement obtained with the treatment ussing the Global rating of changes scale (GROC)
The scale will be administered by one of the researchers. Minimum value -7. Maximum value 7. Higher score = Increased improvement with treatment. Lower scores = 45 / 5.000 Resultados de traducción Resultado de traducción worsening of the patient with treatment.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start12 Dec 2022
- Primary completion12 Oct 2024
- Study completion12 Mar 2025 (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
- Model description
- Through 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 (estimated)
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 Jímenez, Doctor, Study director, University of ValladolidLuis Ceballos Laita, Doctor, Study director, University Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05682235
- Sponsor's protocol ID
- Endometriosis2022
- Status last verified
- Jan 2025
- First submitted
- 26 Dec 2022
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data of the participants will only be kept by the study researchers.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Exercise and Education in Pain Neurophysiology to Improve Pain Intensity in Women With Endometriosis. Clinical Trial.
- ClinicalTrials.gov ID
- NCT05682235
- Acronym / sponsor ID
- Endometriosis2022
- Conditions
- Endometriosis
- Keywords
- Pain, Quality of life, Chronic pelvic pain, therapeutic exercise, pain neurophysiology, physiotherapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ValladolidUniversity, hospital or other
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 12 Oct 2024 (actual)
- Study completion
- 12 Mar 2025 (estimated)
- First posted
- 12 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 improve pain intensity.
Detailed description
A study will be carried out whose objective is to improve the intensity of pain in women with endometriosis through a program of therapeutic exercise and education in the neurophysiology of pain. Also as secondary variables will be observed: kinesiophobia, catastrophism and impression of global improvement with treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Through 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: Therapeutic exercise AND pain neurophysiology educationTherapeutic exercise: Therapeutic exercise is the systematic and planned execution of posture movements and physical activities to correct or prevent alterations, improve or enhance physical functioning, prevent risk factors for solid and optimize 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 diminish the threatening meaning of pain. |
| Sham Comparator | Sham comparator | Other: ShamTalks 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 |
|---|---|---|
| Therapeutic exercise AND pain neurophysiology educationA program of therapeutic exercise and education in the neurophysiology of pain will be applied to the participants of the experimental group and talks on healthy habits to the placebo group participants. | Other | Therapeutic Exercise AND Pain Neurophysiology Education |
| ShamTalk about healthy habits | Other | Sham Comparator |
Primary outcome
Changes in pain perception assessed using a 100mm Visual Analogue Scale (VAS)
Time frame: Baseline, Up to 1 month, Up to 3 months
The scale will be administered by one of the researchers. Minimum value 0. Maximum value 100. Higher score = Higher level of pain. Lowe and lower scores mean a better result.
3 secondary outcomes
Changes in Kinesiofobia assessed using the Tampa Scale of Kinesiofobia (TSK)
Time frame: Baseline, Up to 1 month, Up to 3 months
Changes in Catastrophism assesed using the Pain Catastrophism Scale (PCS)
Time frame: Baseline, Up to 1 month, Up to 3 months
Impression of the overall improvement obtained with the treatment ussing the Global rating of changes scale (GROC)
Time frame: Up to 6 months
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 17 Mar 2025.
- Individual participant dataSharing planned: No. The data of the participants will only be kept by the study researchers.
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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 Jímenez, Doctor study director
University of Valladolid
Luis Ceballos Laita, Doctor study director
University 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 Therapeutic exercise AND pain neurophysiology education 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: under way, not looking for participants, as of the sponsor's last update on 17 Mar 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?
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?
Changes in pain perception assessed using a 100mm Visual Analogue Scale (VAS) (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 17 Mar 2025.