EndometriosisNCT06795243
Efficacy of Physical Therapy Treatment in Endometriosis and Its Relationship to Adherence Rates.
A study testing PAIN NEUROSCIENCE EDUCATION AND THERAPEUTIC EXERCISE PROGRAM in people with Endometriosis and Endometriosis Related Pain, run by University of Seville at 1 site in Spain.
Trial summary
The main objective of this study is to know if the application of both therapies, neuroscience pain education plus therapeutic exercise will modify pain, catastrophizing and quality of life in endometriosis. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis, Endometriosis Related Pain, Endometriosis, Pain
- What is being tested?
- PAIN NEUROSCIENCE EDUCATION AND THERAPEUTIC EXERCISE PROGRAM
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2025to 1 Jul 2026
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult women (over 18 years of age) diagnosed with endometriosis.
- Women with the capacity to carry out a therapeutic program based on muscular exercise.
- Women with the capacity to understand the requirements of the study.
Who cannot join
- Women undergoing fertility and/or assisted reproduction treatment.
- Pregnant women.
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
Universidad de Sevilla
Seville
Inmaculada Villa del Pino, 679183871, inmvildel@alum.us.es
About this study
The main objective of this study is to know if the application of both therapies, neuroscience pain education plus therapeutic exercise will modify pain, catastrophizing and quality of life in endometriosis.
Read the detailed description
Endometriosis is a chronic and inflammatory gynecological condition characterized by the growth of endometrial- like tissue within and outside the pelvic cavity (uterus).
With current means and diagnostic systems, a prevalence of 10% is estimated, although the evidence warns that with the improvement of early diagnosis, these figures will be much higher in the future. One of the main problems with endometriosis is the late diagnosis, which takes an average of seven years. Added to this is the fact that until a definitive diagnosis, patients live in the adolescent stage with symptoms (around 50% with severe pelvic pain) that cause disability and changes in activity and participation in daily life.
At the social level, endometriosis patients are known to have limitations in academic and work activities, as well as in social participation. All of this causes high economic costs.
Chronic pelvic pain can cause the phenomenon of central nervous system sensitization in which pain processing is altered. Pain catastrophizing significantly affects pain disability and vice versa in endometriosis.
Conventional medical care is based on hormonal, pharmacological, and / or surgical treatment and is carried out on an individualized basis depending on the severity of the treatment and the patient's needs.
The multidisciplinary approach to endometriosis has gained relevance in recent decades and has been considered by leaders in the clinical and research sectors. Within the multidisciplinary team, physiotherapy has gained relevance in recent decades.
The multimodal approach of physiotherapy is the one that the Clinical Practice Guidelines and national and international documents demand with greater relevance. Therapeutic exercise based on the work of the abdominal stabilizing musculature and motor control appears to be effective in the treatment of nonspecific low back pain and in endometriosis-related pain. But there is no 'gold standard' in terms of dosage, considering the individualization of treatments.
In the biopsychosocial care paradigm, and specifically in the approach to pathologies with primary chronic pain, patients tend to be motivated and accompanied toward self-determination to achieve adherence to treatment through health education strategies, adequate information, and personalized and goal-oriented multimodal treatment.
However, today, nonadherence is positioned as a global problem, which is growing as the burden of chronicity of pathologies increases, influencing health outcomes and long-term healthcare costs.
Due to symptomatology especially related to chronic pain in endometriosis and in the context of the biopsychosocial paradigm demanded by the scientific community, the investigators consider pertinent the study of catastrophization and its relationship with quality of life and, therefore, disability, and an intervention that addresses in a multimodal way the physiotherapy treatment for endometriosis.
It is recognized that physiotherapeutic interventions based on therapeutic exercise programs, both individual and group, are most effective when tailored to the needs of everyone. Part of this customization should focus on the barriers that each patient recognizes to treatment adherence.
For this reason, the investigators found that studies that support further research to increase the basic understanding of the factors that act as a barrier to adherence in physical therapy treatments could facilitate the development of strategies to overcome nonadherence. And if the investigators follow international recommendations, these systems should address adherence and compliance to treatment from a multidimensional perspective.
Therefore, the investigators believe that measuring compliance and adherence to treatment in this way in patients with endometriosis would allow to know whether adherence to the proposed exercise programs in the target population and their effectiveness are really related or not to the adherence rates to treatment as suggested in recent publications.
In view of the above, this project aims to examine the relationship between the efficacy of physical therapy treatment in patients diagnosed with endometriosis measured in clinical and quality of life terms with short-term compliance and short- and medium-term adherence rates.
- Conditions
- Endometriosis, Endometriosis Related Pain, Endometriosis, Pain, Endometriosis-related Pain, Pain, Pain Intensity Assessment
- Being tested
- PAIN NEUROSCIENCE EDUCATION AND THERAPEUTIC EXERCISE PROGRAM, USUAL CARE
- Keywords
- Endometriosis, Endometriosis Related Pain, Endometriosis, Pain, Pain, Pain Intensity Assessment, Pain Management, Pain, chronic disease, pain score, therapeutic exercise, exercise adherence, Adherence, Treatment, Treatment Adherence and Compliance, Quality of life
- Medical subject headings
- Endometriosis, Pain, Agnosia, Chronic Disease, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAIN NEUROSCIENCE EDUCATION AND THERAPEUTIC EXERCISE PROGRAMProcedure or surgery
PAIN NEUROSCIENCE EDUCATION
- Introduction to the knowledge of pain in the XXI century. Pain as an alarm system.
Types of pain. Differences between acute and chronic pain. 3. Chronic pain. Concepts of kinesiophobia, catastrophism and fear avoidance, self-determination and neuroplasticity.
- Main pain management tools based on scientific evidence. 5. . Transtheoretical model of change. Adherence to treatment, importance as a determinant in health.
- Messages for home. Strategies of active coping in the maintenance stage.
THERAPEUTIC EXERCISE PROGRAM 10-min warm-up. Joint mobility exercises with dual task or gamification. 30-min main part. Sequence of balance work between strength and body flexibility dosed according to the specific needs of each participant.
10-min cool down including breathing exercises and motor imagery. Home exercise program: walking (150 minutes in total, 3 days alternating with the face-to-face sessions).
USUAL CAREProcedure or surgery
The treatment provided is mainly pharmacological, adjusted to the symptomatic profile of theses patients.
Conventional medical care is based on hormonal, pharmacological and/or surgical treatment and is carried out on an individualized basis depending on the severity of the disease and the patient's needs, especially in matters of desire to become pregnant. Surgical treatment is carried out when pharmacological therapy (hormonal or anti-inflammatory) is ineffective or involves adverse events.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Application of a multimodal physical therapy program based on pain education and therapeutic exercise. Sixteen sessions will be carried out. The sessions will be carried out with a frequency of two days a week. Subjects will receive 6 PAIN NEUROSCIENCE EDUCATION (PNE), and 8 weeks (2 times/ week) of therapeutic exercise. Receives: Procedure: PAIN NEUROSCIENCE EDUCATION AND THERAPEUTIC EXERCISE PROGRAM |
| Control Group | Active comparator | Usual Care. Application of standard medical treatment. In Spain, the treatment provided is mainly pharmacological, adjusted to the symptomatic profile of theses patients. Receives: Procedure: USUAL CARE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Self-report Pain magnitude
Magnitude of chronic pain: Chronic pain grading scale. Likert-type scale with 8 items that are evaluated between 0 and 10 for items 2, 3, 4, 6, 7 and 8. Item 1 collects the number of days with pain in the last six months. Item 5 rates the impediment to the performance of usual tasks in the last three months, and can be evaluated between none and 90. The higher the score, the greater the chronic pain involvement. If the score is zero, the patient will be rated as having no pain. Chronic pain will be of low interference with grade I (low intensity) or grade II (high intensity) or of high interference with grade III (moderately limiting) or grade IV (severely limiting). Persistence will be graded as non-persistent or persistent pain.
Measured: At the start of the study (at baseline, 0 week), 1 month and 2 months after the start of the intervention (4 and 8 weeks), 1 month from the last session (12th week), 3 months from the last session (20th week) and 6 months from the last session (32th week
Treatment Compliance
Self-report of the person responsible for managing attendance at the group sessions in the experimental group. Participants who attend 80% or more of the sessions will be considered compliant.
Measured: From enrollment to the end of treatment at 8 weeks
Treatment adherence (Maintenance of the therapeutic exercise program at home )
Adherence to treatment (experimental group), measured by visual analogue scale (VAS) included in the patient diary, in terms of:
Maintenance of treatment at home: number of days that the proposed exercise is performed (100% being 2 times a week). Each patient will complete the VAS scale monthly. Participants with a score equal to or greater than 8 points out of 10 on the VAS scale will be considered to have high adherence.
Measured: From the end of the intervention at 8 weeks (starting at week 9) to the end of treatment at 32 weeks.
Changes from Self-report pain catastrophizing
Catastrophizing thoughts in the face of pain: Pain Catastrophizing Scale (PCS). Pain catastrophizing is a construct that is related to a negative and exaggerated orientation towards painful stimuli. The scale, validated in Spanish, is a list of 13 statements that describe different thoughts and feelings that may be related to pain in the dimensions of rumination, magnification and hopelessness. The person indicates the degree to which he/she has such thoughts or feelings by rating them between 0 (not at all) and 4 (all the time). The theoretical range of the instrument is between 13 and 62, with higher values indicating a higher index of catastrophizing.
Measured: At the start of the study (at baseline, 0 week), 1 month and 2 months after the start of the intervention (4 and 8 weeks), 1 month from the last session (12th week), 3 months from the last session (20th week) and 6 months from the last session (32th week
Change from Self-report specific quality of life
Specific quality of life: Endometriosis Health Profile (EHP-30+23) questionnaire Spanish version. The questionnaire is composed of two parts. Part 1 with 30 itmens and part 2 divided into five subscales: pain, control and helplessness, emotional well-being, social support and self-image. For part 1 and each subscale a total score is created as a percentage of the maximum possible score. 0 is considered the best possible health status and 100 the worst.
Measured: At the start of the study (at baseline, 0 week), 1 month and 2 months after the start of the intervention (4 and 8 weeks), 1 month from the last session (12th week), 3 months from the last session (20th week) and 6 months from the last session (32th week
Changes in self-reported general quality of life
Overall Quality of Life: EUROQOL-5 Dimensions- 3 Levels (EQ-5D-3L). It is a standardized instrument that measures health outcomes and is applicable to a wide range of diseases and treatments. It provides a simple descriptive profile and a single index of health status. The EQ-5D-3L covers 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is assessed in 3 categories (no problems; moderate problems; extreme problems). The assessment consists of measuring each of the 5 domains in one of the 3 categories. In this work we use, as in our reference study, the validated Spanish version of the EQ-5D-3L in its current version for the adult population. EQ-5D © 2025 EuroQol Research Foundation.
Measured: At the start of the study (at baseline, 0 week), 1 month and 2 months after the start of the intervention (4 and 8 weeks), 1 month from the last session (12th week), 3 months from the last session (20th week) and 6 months from the last session (32th week
Secondary outcomes (1)
Exercise-related adverse events
Possible occurrence of pain, frequency of flares and fatigue, measured qualitatively in narrative text through patient diary.
Measured: At the start of the study (at baseline, 0 week), 1 month and 2 months after the start of the intervention (4 and 8 weeks), 1 month from the last session (12th week), 3 months from the last session (20th week) and 6 months from the last session (32th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start1 May 2025
- Primary completion31 May 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Rebollo Salas, University of Seville
- Investigators
- Carmen-María Suárez-Serrano, Study chair, Departamento de Fisioterapia. Facultad de Enfermería, Fisioterapia y Podología de la Universidad de Sevilla.José-Jesús Jiménez-Rejano, Study director, Departamento de Fisioterapia. Facultad de Enfermería, Fisioterapia y Podología de la Universidad de Sevilla.Manuel Rebollo-Salas, Study director, Departamento de Fisioterapia. Facultad de Enfermería, Fisioterapia y Podología de la Universidad de Sevilla.Inmaculada Villa-del-Pino, Principal investigator, Centro universitario San Isidoro, adscrito a Universidad Pablo de Olavide, Sevilla.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795243
- Sponsor's protocol ID
- SICEIA 2024-146
- Status last verified
- Jan 2026
- First submitted
- 11 Jan 2025
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD. The data to be provided will refer to all the variables of the study: independent, dependent and control variables. Dependent (Catastrophic thoughts about pain, magnitude of chronic pain, general quality of life, specific quality of life, adverse events related to exercise ( pain, frequency of flares and fatigue), adherence and compliance to treatment Control variables: * Age (years). * Height: measured in centimeters. * Weight: measured in kilograms. * BMI: (kg/m2). * Work and/or academic activity: measured according to whether the person works, studies or both at the same time. * Academic level: measured according to whether the person has compulsory or higher education. * Stage of pathology: measured in stages according to the American Society for Reproductive Medicine. All this will be carried out preserving the confidentiality of the data of the study participants according to the rules of the Ethics Committee of the University of Seville.
Publications
Garcia Campayo J, Rodero B, Alda M, Sobradiel N, Montero J, Moreno S. [Validation of the Spanish version of the Pain Catastrophizing Scale in fibromyalgia]. Med Clin (Barc). 2008 Oct 18;131(13):487-92. doi: 10.1157/13127277. Spanish.
PubMed 19007576Bordeleau M, Vincenot M, Lefevre S, Duport A, Seggio L, Breton T, Lelard T, Serra E, Roussel N, Neves JFD, Leonard G. Treatments for kinesiophobia in people with chronic pain: A scoping review. Front Behav Neurosci. 2022 Sep 20;16:933483. doi: 10.3389/fnbeh.2022.933483. eCollection 2022.
PubMed 36204486Hamacher D, Hamacher D, Schega L. A cognitive dual task affects gait variability in patients suffering from chronic low back pain. Exp Brain Res. 2014 Nov;232(11):3509-13. doi: 10.1007/s00221-014-4039-1. Epub 2014 Jul 25.
PubMed 25059910Fernandez-Rodriguez R, Alvarez-Bueno C, Cavero-Redondo I, Torres-Costoso A, Pozuelo-Carrascosa DP, Reina-Gutierrez S, Pascual-Morena C, Martinez-Vizcaino V. Best Exercise Options for Reducing Pain and Disability in Adults With Chronic Low Back Pain: Pilates, Strength, Core-Based, and Mind-Body. A Network Meta-analysis. J Orthop Sports Phys Ther. 2022 Aug;52(8):505-521. doi: 10.2519/jospt.2022.10671. Epub 2022 Jun 19.
PubMed 35722759Galan-Martin MA, Montero-Cuadrado F, Lluch-Girbes E, Coca-Lopez MC, Mayo-Iscar A, Cuesta-Vargas A. Pain Neuroscience Education and Physical Therapeutic Exercise for Patients with Chronic Spinal Pain in Spanish Physiotherapy Primary Care: A Pragmatic Randomized Controlled Trial. J Clin Med. 2020 Apr 22;9(4):1201. doi: 10.3390/jcm9041201.
PubMed 32331323Mari-Alexandre J, Garcia-Oms J, Agababyan C, Belda-Montesinos R, Royo-Bolea S, Varo-Gomez B, Diaz-Sierra C, Gonzalez-Canto E, Gilabert-Estelles J. Toward an improved assessment of quality of life in endometriosis: evaluation of the Spanish version of the Endometriosis Health Profile 30. J Psychosom Obstet Gynaecol. 2022 Sep;43(3):251-257. doi: 10.1080/0167482X.2020.1795827. Epub 2020 Jul 31.
PubMed 32735156Jones GL, Budds K, Taylor F, Musson D, Raymer J, Churchman D, Kennedy SH, Jenkinson C. A systematic review to determine use of the Endometriosis Health Profiles to measure quality of life outcomes in women with endometriosis. Hum Reprod Update. 2024 Mar 1;30(2):186-214. doi: 10.1093/humupd/dmad029.
PubMed 38007607Ferrer-Pena R, Gil-Martinez A, Pardo-Montero J, Jimenez-Penick V, Gallego-Izquierdo T, La Touche R. Adaptation and validation of the Spanish version of the graded chronic pain scale. Reumatol Clin. 2016 May-Jun;12(3):130-8. doi: 10.1016/j.reuma.2015.07.004. Epub 2015 Aug 19. English, Spanish.
PubMed 26298083Wheeler CHB, Williams ACC, Morley SJ. Meta-analysis of the psychometric properties of the Pain Catastrophizing Scale and associations with participant characteristics. Pain. 2019 Sep;160(9):1946-1953. doi: 10.1097/j.pain.0000000000001494.
PubMed 30694929Xu Y, Deng Z, Fei F, Zhou S. An overview and comprehensive analysis of interdisciplinary clinical research in endometriosis based on trial registry. iScience. 2024 Feb 20;27(3):109298. doi: 10.1016/j.isci.2024.109298. eCollection 2024 Mar 15.
PubMed 38455973Tennfjord MK, Gabrielsen R, Tellum T. Effect of physical activity and exercise on endometriosis-associated symptoms: a systematic review. BMC Womens Health. 2021 Oct 9;21(1):355. doi: 10.1186/s12905-021-01500-4.
PubMed 34627209Tourny C, Zouita A, El Kababi S, Feuillet L, Saeidi A, Laher I, Weiss K, Knechtle B, Zouhal H. Endometriosis and physical activity: A narrative review. Int J Gynaecol Obstet. 2023 Dec;163(3):747-756. doi: 10.1002/ijgo.14898. Epub 2023 Jun 22.
PubMed 37345574McLean SM, Burton M, Bradley L, Littlewood C. Interventions for enhancing adherence with physiotherapy: a systematic review. Man Ther. 2010 Dec;15(6):514-21. doi: 10.1016/j.math.2010.05.012. Epub 2010 Jul 14.
PubMed 20630793Jack K, McLean SM, Moffett JK, Gardiner E. Barriers to treatment adherence in physiotherapy outpatient clinics: a systematic review. Man Ther. 2010 Jun;15(3):220-8. doi: 10.1016/j.math.2009.12.004. Epub 2010 Feb 16.
PubMed 20163979Nagpal TS, Mottola MF, Barakat R, Prapavessis H. Adherence is a key factor for interpreting the results of exercise interventions. Physiotherapy. 2021 Dec;113:8-11. doi: 10.1016/j.physio.2021.05.010. Epub 2021 Sep 21.
PubMed 34555674
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Physical Therapy Treatment in Endometriosis and Its Relationship to Adherence Rates.
- ClinicalTrials.gov ID
- NCT06795243
- Acronym / sponsor ID
- SICEIA 2024-146
- Conditions
- Endometriosis, Endometriosis Related Pain, Endometriosis, Pain, Endometriosis-related Pain, Pain, Pain Intensity Assessment
- Keywords
- Endometriosis, Endometriosis Related Pain, Endometriosis, Pain, Pain, Pain Intensity Assessment, Pain Management, Pain, chronic disease, pain score
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 28 Jan 2025 (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 main objective of this study is to know if the application of both therapies, neuroscience pain education plus therapeutic exercise will modify pain, catastrophizing and quality of life in endometriosis.
Detailed description
Endometriosis is a chronic and inflammatory gynecological condition characterized by the growth of endometrial- like tissue within and outside the pelvic cavity (uterus).
With current means and diagnostic systems, a prevalence of 10% is estimated, although the evidence warns that with the improvement of early diagnosis, these figures will be much higher in the future. One of the main problems with endometriosis is the late diagnosis, which takes an average of seven years. Added to this is the fact that until a definitive diagnosis, patients live in the adolescent stage with symptoms (around 50% with severe pelvic pain) that cause disability and changes in activity and participation in daily life.
At the social level, endometriosis patients are known to have limitations in academic and work activities, as well as in social participation. All of this causes high economic costs.
Chronic pelvic pain can cause the phenomenon of central nervous system sensitization in which pain processing is altered. Pain catastrophizing significantly affects pain disability and vice versa in endometriosis.
Conventional medical care is based on hormonal, pharmacological, and / or surgical treatment and is carried out on an individualized basis depending on the severity of the treatment and the patient's needs.
The multidisciplinary approach to endometriosis has gained relevance in recent decades and has been considered by leaders in the clinical and research sectors. Within the multidisciplinary team, physiotherapy has gained relevance in recent decades.
The multimodal approach of physiotherapy is the one that the Clinical Practice Guidelines and national and international documents demand with greater relevance. Therapeutic exercise based on the work of the abdominal stabilizing musculature and motor control appears to be effective in the treatment of nonspecific low back pain and in endometriosis-related pain. But there is no 'gold standard' in terms of dosage, considering the individualization of treatments.
In the biopsychosocial care paradigm, and specifically in the approach to pathologies with primary chronic pain, patients tend to be motivated and accompanied toward self-determination to achieve adherence to treatment through health education strategies, adequate information, and personalized and goal-oriented multimodal treatment.
However, today, nonadherence is positioned as a global problem, which is growing as the burden of chronicity of pathologies increases, influencing health outcomes and long-term healthcare costs.
Due to symptomatology especially related to chronic pain in endometriosis and in the context of the biopsychosocial paradigm demanded by the scientific community, the investigators consider pertinent the study of catastrophization and its relationship with quality of life and, therefore, disability, and an intervention that addresses in a multimodal way the physiotherapy treatment for endometriosis.
It is recognized that physiotherapeutic interventions based on therapeutic exercise programs, both individual and group, are most effective when tailored to the needs of everyone. Part of this customization should focus on the barriers that each patient recognizes to treatment adherence.
For this reason, the investigators found that studies that support further research to increase the basic understanding of the factors that act as a barrier to adherence in physical therapy treatments could facilitate the development of strategies to overcome nonadherence. And if the investigators follow international recommendations, these systems should address adherence and compliance to treatment from a multidimensional perspective.
Therefore, the investigators believe that measuring compliance and adherence to treatment in this way in patients with endometriosis would allow to know whether adherence to the proposed exercise programs in the target population and their effectiveness are really related or not to the adherence rates to treatment as suggested in recent publications.
In view of the above, this project aims to examine the relationship between the efficacy of physical therapy treatment in patients diagnosed with endometriosis measured in clinical and quality of life terms with short-term compliance and short- and medium-term adherence rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Procedure: PAIN NEUROSCIENCE EDUCATION AND THERAPEUTIC EXERCISE PROGRAMApplication of a multimodal physical therapy program based on pain education and therapeutic exercise. Sixteen sessions will be carried out. The sessions will be carried out with a frequency of two days a week. Subjects will receive 6 PAIN NEUROSCIENCE EDUCATION (PNE), and 8 weeks (2 times/ week) of therapeutic exercise. |
| Control Group | Active comparator | Procedure: USUAL CAREUsual Care. Application of standard medical treatment. In Spain, the treatment provided is mainly pharmacological, adjusted to the symptomatic profile of theses patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult women (over 18 years of age) diagnosed with endometriosis.
- Women with the capacity to carry out a therapeutic program based on muscular exercise.
- Women with the capacity to understand the requirements of the study.
Key exclusion criteria (2 listed)
- Women undergoing fertility and/or assisted reproduction treatment.
- Pregnant women.
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 |
|---|---|---|
| PAIN NEUROSCIENCE EDUCATION AND THERAPEUTIC EXERCISE PROGRAMPAIN NEUROSCIENCE EDUCATION 1. Introduction to the knowledge of pain in the XXI century. Pain as an alarm system. Types of pain. Differences between acute and chronic pain. 3. Chronic pain. Concepts of kinesiophobia, catastrophism and fear avoidance, self-determination and neuroplasticity. 4. Main pain management tools based on scientific evidence. 5. . Transtheoretical model of change. Adherence to treatment, importance as a determinant in health. 6. Messages for home. Strategies of active coping in the maintenance stage. THERAPEUTIC EXERCISE PROGRAM 10-min warm-up. Joint mobility exercises with dual task or gamification. 30-min main part. Sequence of balance work between strength and body flexibility dosed according to the specific needs of each participant. 10-min cool down including breathing exercises and motor imagery. Home exercise program: walking (150 minutes in total, 3 days alternating with the face-to-face sessions). | Procedure or surgery | Experimental Group |
| USUAL CAREThe treatment provided is mainly pharmacological, adjusted to the symptomatic profile of theses patients. Conventional medical care is based on hormonal, pharmacological and/or surgical treatment and is carried out on an individualized basis depending on the severity of the disease and the patient's needs, especially in matters of desire to become pregnant. Surgical treatment is carried out when pharmacological therapy (hormonal or anti-inflammatory) is ineffective or involves adverse events. | Procedure or surgery | Control Group |
Primary outcome
Change from Self-report Pain magnitude
Time frame: At the start of the study (at baseline, 0 week), 1 month and 2 months after the start of the intervention (4 and 8 weeks), 1 month from the last session (12th week), 3 months from the last session (20th week) and 6 months from the last session (32th week
Magnitude of chronic pain: Chronic pain grading scale. Likert-type scale with 8 items that are evaluated between 0 and 10 for items 2, 3, 4, 6, 7 and 8. Item 1 collects the number of days with pain in the last six months. Item 5 rates the impediment to the performance of usual tasks in the last three months, and can be evaluated between none and 90. The higher the score, the greater the chronic pain involvement. If the score is zero, the patient will be rated as having no pain. Chronic pain will be of low interference with grade I (low intensity) or grade II (high intensity) or of high interference with grade III (moderately limiting) or grade IV (severely limiting). Persistence will be graded as non-persistent or persistent pain.
Treatment Compliance
Time frame: From enrollment to the end of treatment at 8 weeks
Self-report of the person responsible for managing attendance at the group sessions in the experimental group. Participants who attend 80% or more of the sessions will be considered compliant.
Treatment adherence (Maintenance of the therapeutic exercise program at home )
Time frame: From the end of the intervention at 8 weeks (starting at week 9) to the end of treatment at 32 weeks.
Adherence to treatment (experimental group), measured by visual analogue scale (VAS) included in the patient diary, in terms of: Maintenance of treatment at home: number of days that the proposed exercise is performed (100% being 2 times a week). Each patient will complete the VAS scale monthly. Participants with a score equal to or greater than 8 points out of 10 on the VAS scale will be considered to have high adherence.
Changes from Self-report pain catastrophizing
Time frame: At the start of the study (at baseline, 0 week), 1 month and 2 months after the start of the intervention (4 and 8 weeks), 1 month from the last session (12th week), 3 months from the last session (20th week) and 6 months from the last session (32th week
Catastrophizing thoughts in the face of pain: Pain Catastrophizing Scale (PCS). Pain catastrophizing is a construct that is related to a negative and exaggerated orientation towards painful stimuli. The scale, validated in Spanish, is a list of 13 statements that describe different thoughts and feelings that may be related to pain in the dimensions of rumination, magnification and hopelessness. The person indicates the degree to which he/she has such thoughts or feelings by rating them between 0 (not at all) and 4 (all the time). The theoretical range of the instrument is between 13 and 62, with higher values indicating a higher index of catastrophizing.
Change from Self-report specific quality of life
Time frame: At the start of the study (at baseline, 0 week), 1 month and 2 months after the start of the intervention (4 and 8 weeks), 1 month from the last session (12th week), 3 months from the last session (20th week) and 6 months from the last session (32th week
Specific quality of life: Endometriosis Health Profile (EHP-30+23) questionnaire Spanish version. The questionnaire is composed of two parts. Part 1 with 30 itmens and part 2 divided into five subscales: pain, control and helplessness, emotional well-being, social support and self-image. For part 1 and each subscale a total score is created as a percentage of the maximum possible score. 0 is considered the best possible health status and 100 the worst.
Changes in self-reported general quality of life
Time frame: At the start of the study (at baseline, 0 week), 1 month and 2 months after the start of the intervention (4 and 8 weeks), 1 month from the last session (12th week), 3 months from the last session (20th week) and 6 months from the last session (32th week
Overall Quality of Life: EUROQOL-5 Dimensions- 3 Levels (EQ-5D-3L). It is a standardized instrument that measures health outcomes and is applicable to a wide range of diseases and treatments. It provides a simple descriptive profile and a single index of health status. The EQ-5D-3L covers 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is assessed in 3 categories (no problems; moderate problems; extreme problems). The assessment consists of measuring each of the 5 domains in one of the 3 categories. In this work we use, as in our reference study, the validated Spanish version of the EQ-5D-3L in its current version for the adult population. EQ-5D © 2025 EuroQol Research Foundation.
1 secondary outcome
Exercise-related adverse events
Time frame: At the start of the study (at baseline, 0 week), 1 month and 2 months after the start of the intervention (4 and 8 weeks), 1 month from the last session (12th week), 3 months from the last session (20th week) and 6 months from the last session (32th week
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 6 Apr 2026.
- Background: PubMed 19007576Garcia Campayo J, Rodero B, Alda M, Sobradiel N, Montero J, Moreno S. [Validation of the Spanish version of the Pain Catastrophizing Scale in fibromyalgia]. Med Clin (Barc). 2008 Oct 18;131(13):487-92. doi: 10.1157/13127277. Spanish.
- Background: PubMed 36204486Bordeleau M, Vincenot M, Lefevre S, Duport A, Seggio L, Breton T, Lelard T, Serra E, Roussel N, Neves JFD, Leonard G. Treatments for kinesiophobia in people with chronic pain: A scoping review. Front Behav Neurosci. 2022 Sep 20;16:933483. doi: 10.3389/fnbeh.2022.933483. eCollection 2022.
- Background: PubMed 25059910Hamacher D, Hamacher D, Schega L. A cognitive dual task affects gait variability in patients suffering from chronic low back pain. Exp Brain Res. 2014 Nov;232(11):3509-13. doi: 10.1007/s00221-014-4039-1. Epub 2014 Jul 25.
- Background: PubMed 35722759Fernandez-Rodriguez R, Alvarez-Bueno C, Cavero-Redondo I, Torres-Costoso A, Pozuelo-Carrascosa DP, Reina-Gutierrez S, Pascual-Morena C, Martinez-Vizcaino V. Best Exercise Options for Reducing Pain and Disability in Adults With Chronic Low Back Pain: Pilates, Strength, Core-Based, and Mind-Body. A Network Meta-analysis. J Orthop Sports Phys Ther. 2022 Aug;52(8):505-521. doi: 10.2519/jospt.2022.10671. Epub 2022 Jun 19.
- Background: PubMed 32331323Galan-Martin MA, Montero-Cuadrado F, Lluch-Girbes E, Coca-Lopez MC, Mayo-Iscar A, Cuesta-Vargas A. Pain Neuroscience Education and Physical Therapeutic Exercise for Patients with Chronic Spinal Pain in Spanish Physiotherapy Primary Care: A Pragmatic Randomized Controlled Trial. J Clin Med. 2020 Apr 22;9(4):1201. doi: 10.3390/jcm9041201.
- Background: PubMed 32735156Mari-Alexandre J, Garcia-Oms J, Agababyan C, Belda-Montesinos R, Royo-Bolea S, Varo-Gomez B, Diaz-Sierra C, Gonzalez-Canto E, Gilabert-Estelles J. Toward an improved assessment of quality of life in endometriosis: evaluation of the Spanish version of the Endometriosis Health Profile 30. J Psychosom Obstet Gynaecol. 2022 Sep;43(3):251-257. doi: 10.1080/0167482X.2020.1795827. Epub 2020 Jul 31.
- Background: PubMed 38007607Jones GL, Budds K, Taylor F, Musson D, Raymer J, Churchman D, Kennedy SH, Jenkinson C. A systematic review to determine use of the Endometriosis Health Profiles to measure quality of life outcomes in women with endometriosis. Hum Reprod Update. 2024 Mar 1;30(2):186-214. doi: 10.1093/humupd/dmad029.
- Background: PubMed 26298083Ferrer-Pena R, Gil-Martinez A, Pardo-Montero J, Jimenez-Penick V, Gallego-Izquierdo T, La Touche R. Adaptation and validation of the Spanish version of the graded chronic pain scale. Reumatol Clin. 2016 May-Jun;12(3):130-8. doi: 10.1016/j.reuma.2015.07.004. Epub 2015 Aug 19. English, Spanish.
- Background: PubMed 30694929Wheeler CHB, Williams ACC, Morley SJ. Meta-analysis of the psychometric properties of the Pain Catastrophizing Scale and associations with participant characteristics. Pain. 2019 Sep;160(9):1946-1953. doi: 10.1097/j.pain.0000000000001494.
- Background: PubMed 38455973Xu Y, Deng Z, Fei F, Zhou S. An overview and comprehensive analysis of interdisciplinary clinical research in endometriosis based on trial registry. iScience. 2024 Feb 20;27(3):109298. doi: 10.1016/j.isci.2024.109298. eCollection 2024 Mar 15.
- Background: PubMed 34627209Tennfjord MK, Gabrielsen R, Tellum T. Effect of physical activity and exercise on endometriosis-associated symptoms: a systematic review. BMC Womens Health. 2021 Oct 9;21(1):355. doi: 10.1186/s12905-021-01500-4.
- Background: PubMed 37345574Tourny C, Zouita A, El Kababi S, Feuillet L, Saeidi A, Laher I, Weiss K, Knechtle B, Zouhal H. Endometriosis and physical activity: A narrative review. Int J Gynaecol Obstet. 2023 Dec;163(3):747-756. doi: 10.1002/ijgo.14898. Epub 2023 Jun 22.
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- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All collected IPD. The data to be provided will refer to all the variables of the study: independent, dependent and control variables. Dependent (Catastrophic thoughts about pain, magnitude of chronic pain, general quality of life, specific quality of life, adverse events related to exercise ( pain, frequency of flares and fatigue), adherence and compliance to treatment Control variables: * Age (years). * Height: measured in centimeters. * Weight: measured in kilograms. * BMI: (kg/m2). * Work and/or academic activity: measured according to whether the person works, studies or both at the same time. * Academic level: measured according to whether the person has compulsory or higher education. * Stage of pathology: measured in stages according to the American Society for Reproductive Medicine. All this will be carried out preserving the confidentiality of the data of the study participants according to the rules of the Ethics Committee of the University of Seville.
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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.
Carmen-María Suárez-Serrano study chair
Departamento de Fisioterapia. Facultad de Enfermería, Fisioterapia y Podología de la Universidad de Sevilla.
José-Jesús Jiménez-Rejano study director
Departamento de Fisioterapia. Facultad de Enfermería, Fisioterapia y Podología de la Universidad de Sevilla.
Manuel Rebollo-Salas study director
Departamento de Fisioterapia. Facultad de Enfermería, Fisioterapia y Podología de la Universidad de Sevilla.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAIN NEUROSCIENCE EDUCATION AND THERAPEUTIC EXERCISE PROGRAM in people with Endometriosis and Endometriosis Related Pain, run by University of Seville 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 2 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 6 Apr 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 Inmaculada Villa-del-Pino (+34679183871, inmvildel@alum.us.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Self-report Pain magnitude (time frame: At the start of the study (at baseline, 0 week), 1 month and 2 months after the start of the intervention (4 and 8 weeks), 1 month from the last session (12th week), 3 months from the last session (20th week) and 6 months from the last session (32th week). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06795243, which also lists 30 linked publications.
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 6 Apr 2026.