EndometriosisNCT06209346
Multimodal Physiotherapy Based on Tele-rehabilitation in Chronic Pelvic Pain Associated With Endometriosis
A study testing TeleRehab Group and Advices Group in people with Endometriosis and Chronic Pelvic Pain Syndrome, run by University of Alcala at 1 site in Spain.
Trial summary
Objective: To determine if the tele-rehabilitation program for chronic pelvic pain associated with endometriosis composed of pain education, therapeutic exercise and respiratory control decreases pain according to the Visual Numerical Scale (EVN), catastrophizing with the Pain Catastrophizing Scale (PCS)… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Endometriosis, Chronic Pelvic Pain Syndrome
- What is being tested?
- TeleRehab Group and Advices Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSpain
- Study dates
- 27 Nov 2023to 17 Jan 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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with a medical diagnosis of endometriosis.
- Age equal to or older than 18 years and up to 55 years.
- Who are or have received medical and/or surgical treatment and with controlled disease.
- Persistent pelvic pain for at least 3 months.
- Pain greater than 4 on the EVN.
- No cognitive limitation to understand the information sheet, instructions and freely sign the informed consent
Show all 9Show fewer
- Have any electronic device available (tablet, computer, cell phone).
- Have a current email address.
- Have a valid e-mail address.
Who cannot join
- Peri- and postmenopausal women.
- Women pregnant or desiring gestation during the study.
- Women with a history of gynecologic cancer and/or undergoing any systemic and/or localized oncologic treatment in the pelviperineal region
- Women with a diagnosis of chronic fatigue or fibromyalgia▪.
- Women concomitantly participating in another intervention study.
- Women undergoing surgery during the study.
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
Physiotherapy in women´s health research group. University of Alcalà
Alcalà de Henares, Madrid, 28871
María Torres-Lacomba, PhD, maria.torres@uah.es
About this study
- Objective: To determine if the tele-rehabilitation program for chronic pelvic pain associated with endometriosis composed of pain education, therapeutic exercise and respiratory control decreases pain according to the Visual Numerical Scale (EVN), catastrophizing with the Pain Catastrophizing Scale (PCS), kinesiophobia with the Tampa Scale of Kinesiophobia (TSK), improves sexual function according to the Female Sexual Function Index (FSFI) and QoL compared to the Control Group with the Health Status Questionnaire (SF-12).
- Follow-up: four evaluated questionnaires: preintervention; postintervention, 3 months postintervention, 6 months postintervention
- Participants: 66 women diagnosed with endometriosis with chronic pelvic pain in different Spanish endometriosis associations.
- Randomization: women will be randomly assigned to two groups using the EpiData 3.1 software
- Interventions: Experimental Group: therapeutic exercise + conscious breathing (16 sessions) and pain education (4 sessions) through the TRAK platform.
Control Group: They will receive informative material in weeks 1, 3, 5 and 7 about their pathology and with recommendations for them to achieve healthy lifestyle habits that do not further damage their disease.
- Conditions
- Endometriosis, Chronic Pelvic Pain Syndrome
- Being tested
- TeleRehab Group, Advices Group
- Keywords
- endometriosis, chronic pelvic pain, physical therapy, pain education
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeleRehab GroupOther
Also called TrhbG
The duration of treatment for the Experimental Group will be 8 weeks and will consist of a total of 20 sessions, with between 2 and 3 sessions per week depending on the week they are in.
Weeks 2, 4, 6 and 8 will have 2 sessions per week and weeks 1, 3, 5 and 7 will have 3 sessions per week.
These sessions will consist of videos that will make up the educational material, videos that will guide the ET program and respiratory control practices.All the sessions mentioned above will be in online format, through the TRAK platform.
Advices GroupOther
Also called AG
They will receive informative material in weeks 1, 3, 5 and 7 about their pathology and with recommendations for them to achieve healthy lifestyle habits that do not further damage their disease. Participants in the Control Group will have the same follow-up evaluations as the Experimental Group and will receive informative material. They will not have access to the audiovisual material generated for the Experimental Group.
| Study group | Role | What they receive |
|---|---|---|
| TeleRehab Group | Experimental | The duration of treatment for the TeleRehab Group will be 8 weeks and will consist of a total of 20 sessions, with between 2 and 3 sessions per week depending on the week they are in.
Weeks 2, 4, 6 and 8 will have 2 sessions per week and weeks 1, 3, 5 and 7 will have 3 sessions per week.
These sessions will consist of videos that will make up the educational material, videos that will guide the TE program and respiratory control practices. All the sessions mentioned above will be in online format, through the TRAK platform. Receives: Other: TeleRehab Group |
| Advices Group | Active comparator | They will receive informative material in weeks 1, 3, 5 and 7 about their pathology and with recommendations for them to achieve healthy lifestyle habits that do not further damage their disease. o Participants in the Advices Group will have the same follow-up assessments as the TeleRehab Group and will receive informative material. They will not have access to the audiovisual material generated for the TeleRehabGroup. Receives: Other: Advices Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Status Questionnaire (SF-12)
Change from baseline in quality of life at two month (post-intervention); and 3 and 5 months post-intervention
Measured: Pre-intervention (baseline); Post-intervention (two month from baseline); and 3 and 5 months post-intervention. A score of 0 means poorer health and a score of 100 means better health.
Visual Numeric Scale (VNS)
Change from baseline in pain at two month (post-intervention); and 3 and 5 months post-intervention
Measured: Pre-intervention (baseline); Post-intervention (two month from baseline); and 3 and 5 months post-intervention. A score of 0 means no pain, 1 to 3 means mild pain, 4 to 6 means moderate pain and 7 to 10 means severe pain.
Endometriosis Health Profile (EHP-30)
Change from baseline in endometriosis affectation at two month (post-intervention); and 3 and 5 months post-intervention
Measured: Pre-intervention (baseline); Post-intervention (two month from baseline); and 3 and 5 months post-intervention. A score of 0 indicates the best health status to the worst health status of 100.
Index of Sexual Function (IFSF)
Change from baseline in sexual function at two month (post-intervention); and 3 and 5 months post-intervention
Measured: Pre-intervention (baseline); Post-intervention (two month from baseline); and 3 and 5 months post-intervention. The final score (total score: minimum 2 and maximum 36). The higher the better sexual function, the lower the worse sexual function.
Tampa Scale of Kinesiophobia (TSK)
Change from baseline in kinesiophobia at two month (post-intervention); and 3 and 5 months post-intervention
Measured: Pre-intervention (baseline); Post-intervention (two month from baseline); and 3 and 5 months post-intervention. The lowest possible score, 11, no kinesiophobia. The highest possible score, 44, denotes a severe kinesophobia
Pain Catastrophizing Scale (PCS)
Change from baseline in catastrophixing at two month (post-intervention); and 3 and 5 months post-intervention
Measured: Pre-intervention (baseline); Post-intervention (two month from baseline); and 3 and 5 months post-intervention. The overall score has a range of 0-52. Higher scores indicate a greater degree of pain catastrophizing.
Secondary outcomes (6)
Hospital Anxiety and Depression Scale (HADS)
Change from baseline in anxiety and depression at two month (post-intervention); and 3 and 5 months post-intervention
Measured: Pre-intervention (baseline); Post-intervention (two month from baseline); and 3 and 5 months post-intervention. The overall score ranges from 0 to 21 points. Normal range (0-7), Possible A/D (8-10) and Case A/D
International Physical Activity Questionnaire (IPAQ)
Change from baseline in physical activity at two month (post-intervention); and 3 and 5 months post-intervention
Measured: Pre-intervention (baseline); Post-intervention (two month from baseline); and 3 and 5 months post-intervention. Low: low physical activity Medium: 3+days of vigorous physical activity.High:performs vigorous physical activity reaching a high energy
Pittsburg Sleep Quality Index (PSQI)
Change from baseline in sleep quality at two month (post-intervention); and 3 and 5 months post-intervention
Measured: Pre-intervention (baseline); Post-intervention (two month from baseline); and 3 and 5 months post-intervention. The overall score ranges from 0 (no difficulty) to 21 (difficulties in all areas).
Perceived Stress Scale (PSS)
Change from baseline in stress at two month (post-intervention); and 3 and 5 months post-intervention
Measured: Pre-intervention (baseline); Post-intervention (two month from baseline); and 3 and 5 months post-intervention. The score ranges from 0 to 56 and indicates that a higher score corresponds to a higher level of perceived stress.
Patient's adherence will be evaluated
Adherence (via TRAK Platform with email and chat)
Measured: Pre-intervention (baseline); Post-intervention (two month from baseline); and 3 and 5 months post-intervention
Patient global impression of change (PGI-I)
Patient global impression of change (PGI-I)
Measured: Pre-intervention (baseline); Post-intervention (two month from baseline). The score ranges from 1 to 7 and indicates that a higher score corresponds to worsening with treatment and a lower score to improvement with treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start27 Nov 2023
- Primary completion17 Jan 2025 (estimated)
- Study completion17 Jan 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
- Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Torres Lacomba, University of Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209346
- Sponsor's protocol ID
- CEID/2023/6/106
- Status last verified
- Jul 2023
- First submitted
- 5 Dec 2023
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Physiotherapy Based on Tele-rehabilitation in Chronic Pelvic Pain Associated With Endometriosis
- ClinicalTrials.gov ID
- NCT06209346
- Acronym / sponsor ID
- CEID/2023/6/106
- Conditions
- Endometriosis, Chronic Pelvic Pain Syndrome
- Keywords
- endometriosis, chronic pelvic pain, physical therapy, pain education
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 17 Jan 2025 (estimated)
- Study completion
- 17 Jan 2027 (estimated)
- First posted
- 17 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.
- Objective: To determine if the tele-rehabilitation program for chronic pelvic pain associated with endometriosis composed of pain education, therapeutic exercise and respiratory control decreases pain according to the Visual Numerical Scale (EVN), catastrophizing with the Pain Catastrophizing Scale (PCS), kinesiophobia with the Tampa Scale of Kinesiophobia (TSK), improves sexual function according to the Female Sexual Function Index (FSFI) and QoL compared to the Control Group with the Health Status Questionnaire (SF-12).
- Follow-up: four evaluated questionnaires: preintervention; postintervention, 3 months postintervention, 6 months postintervention
- Participants: 66 women diagnosed with endometriosis with chronic pelvic pain in different Spanish endometriosis associations.
- Randomization: women will be randomly assigned to two groups using the EpiData 3.1 software
- Interventions: Experimental Group: therapeutic exercise + conscious breathing (16 sessions) and pain education (4 sessions) through the TRAK platform.
Control Group: They will receive informative material in weeks 1, 3, 5 and 7 about their pathology and with recommendations for them to achieve healthy lifestyle habits that do not further damage their disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TeleRehab Group | Experimental | Other: TeleRehab GroupThe duration of treatment for the TeleRehab Group will be 8 weeks and will consist of a total of 20 sessions, with between 2 and 3 sessions per week depending on the week they are in. Weeks 2, 4, 6 and 8 will have 2 sessions per week and weeks 1, 3, 5 and 7 will have 3 sessions per week. These sessions will consist of videos that will make up the educational material, videos that will guide the TE program and respiratory control practices. All the sessions mentioned above will be in online format, through the TRAK platform. |
| Advices Group | Active comparator | Other: Advices GroupThey will receive informative material in weeks 1, 3, 5 and 7 about their pathology and with recommendations for them to achieve healthy lifestyle habits that do not further damage their disease. o Participants in the Advices Group will have the same follow-up assessments as the TeleRehab Group and will receive informative material. They will not have access to the audiovisual material generated for the TeleRehabGroup. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Women with a medical diagnosis of endometriosis.
- Age equal to or older than 18 years and up to 55 years.
- Who are or have received medical and/or surgical treatment and with controlled disease.
- Persistent pelvic pain for at least 3 months.
- Pain greater than 4 on the EVN.
Key exclusion criteria (6 listed)
- Peri- and postmenopausal women.
- Women pregnant or desiring gestation during the study.
- Women with a history of gynecologic cancer and/or undergoing any systemic and/or localized oncologic treatment in the pelviperineal region
- Women with a diagnosis of chronic fatigue or fibromyalgia▪.
- Women concomitantly participating in another intervention 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 |
|---|---|---|
| TeleRehab GroupAlso: TrhbGThe duration of treatment for the Experimental Group will be 8 weeks and will consist of a total of 20 sessions, with between 2 and 3 sessions per week depending on the week they are in. Weeks 2, 4, 6 and 8 will have 2 sessions per week and weeks 1, 3, 5 and 7 will have 3 sessions per week. These sessions will consist of videos that will make up the educational material, videos that will guide the ET program and respiratory control practices.All the sessions mentioned above will be in online format, through the TRAK platform. | Other | TeleRehab Group |
| Advices GroupAlso: AGThey will receive informative material in weeks 1, 3, 5 and 7 about their pathology and with recommendations for them to achieve healthy lifestyle habits that do not further damage their disease. Participants in the Control Group will have the same follow-up evaluations as the Experimental Group and will receive informative material. They will not have access to the audiovisual material generated for the Experimental Group. | Other | Advices Group |
Primary outcome
Health Status Questionnaire (SF-12)
Time frame: Pre-intervention (baseline); Post-intervention (two month from baseline); and 3 and 5 months post-intervention. A score of 0 means poorer health and a score of 100 means better health.
Change from baseline in quality of life at two month (post-intervention); and 3 and 5 months post-intervention
Visual Numeric Scale (VNS)
Time frame: Pre-intervention (baseline); Post-intervention (two month from baseline); and 3 and 5 months post-intervention. A score of 0 means no pain, 1 to 3 means mild pain, 4 to 6 means moderate pain and 7 to 10 means severe pain.
Change from baseline in pain at two month (post-intervention); and 3 and 5 months post-intervention
Endometriosis Health Profile (EHP-30)
Time frame: Pre-intervention (baseline); Post-intervention (two month from baseline); and 3 and 5 months post-intervention. A score of 0 indicates the best health status to the worst health status of 100.
Change from baseline in endometriosis affectation at two month (post-intervention); and 3 and 5 months post-intervention
Index of Sexual Function (IFSF)
Time frame: Pre-intervention (baseline); Post-intervention (two month from baseline); and 3 and 5 months post-intervention. The final score (total score: minimum 2 and maximum 36). The higher the better sexual function, the lower the worse sexual function.
Change from baseline in sexual function at two month (post-intervention); and 3 and 5 months post-intervention
Tampa Scale of Kinesiophobia (TSK)
Time frame: Pre-intervention (baseline); Post-intervention (two month from baseline); and 3 and 5 months post-intervention. The lowest possible score, 11, no kinesiophobia. The highest possible score, 44, denotes a severe kinesophobia
Change from baseline in kinesiophobia at two month (post-intervention); and 3 and 5 months post-intervention
Pain Catastrophizing Scale (PCS)
Time frame: Pre-intervention (baseline); Post-intervention (two month from baseline); and 3 and 5 months post-intervention. The overall score has a range of 0-52. Higher scores indicate a greater degree of pain catastrophizing.
Change from baseline in catastrophixing at two month (post-intervention); and 3 and 5 months post-intervention
6 secondary outcomes
Hospital Anxiety and Depression Scale (HADS)
Time frame: Pre-intervention (baseline); Post-intervention (two month from baseline); and 3 and 5 months post-intervention. The overall score ranges from 0 to 21 points. Normal range (0-7), Possible A/D (8-10) and Case A/D
International Physical Activity Questionnaire (IPAQ)
Time frame: Pre-intervention (baseline); Post-intervention (two month from baseline); and 3 and 5 months post-intervention. Low: low physical activity Medium: 3+days of vigorous physical activity.High:performs vigorous physical activity reaching a high energy
Pittsburg Sleep Quality Index (PSQI)
Time frame: Pre-intervention (baseline); Post-intervention (two month from baseline); and 3 and 5 months post-intervention. The overall score ranges from 0 (no difficulty) to 21 (difficulties in all areas).
Perceived Stress Scale (PSS)
Time frame: Pre-intervention (baseline); Post-intervention (two month from baseline); and 3 and 5 months post-intervention. The score ranges from 0 to 56 and indicates that a higher score corresponds to a higher level of perceived stress.
Patient's adherence will be evaluated
Time frame: Pre-intervention (baseline); Post-intervention (two month from baseline); and 3 and 5 months post-intervention
Patient global impression of change (PGI-I)
Time frame: Pre-intervention (baseline); Post-intervention (two month from baseline). The score ranges from 1 to 7 and indicates that a higher score corresponds to worsening with treatment and a lower score to improvement with treatment.
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 Jan 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TeleRehab Group and Advices Group in people with Endometriosis and Chronic Pelvic Pain Syndrome, run by University of Alcala 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 9 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: looking for participants now, as of the sponsor's last update on 17 Jan 2024. 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 María Torres-Lacomba, PhD (918856875, maria.torres@uah.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Status Questionnaire (SF-12) (time frame: Pre-intervention (baseline); Post-intervention (two month from baseline); and 3 and 5 months post-intervention. A score of 0 means poorer health and a score of 100 means better health.). 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?
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 Jan 2024.