Multimodal Physiotherapy Based on Tele-rehabilitation in Chronic Pelvic Pain Associated With Endometriosis
NCT ID: NCT06209346
Last Updated: 2024-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
66 participants
INTERVENTIONAL
2023-11-27
2027-01-17
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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TeleRehab Group
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.
TeleRehab Group
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 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. 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.
Advices 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. 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.
Interventions
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TeleRehab Group
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 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. 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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Have any electronic device available (tablet, computer, cell phone).
* Have a current email address.
* Have a valid e-mail address.
Exclusion Criteria
* 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.
18 Years
55 Years
FEMALE
No
Sponsors
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University of Alcala
OTHER
Responsible Party
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Maria Torres Lacomba
Professor
Locations
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Physiotherapy in women´s health research group. University of Alcalà
Alcalà de Henares, Madrid, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CEID/2023/6/106
Identifier Type: -
Identifier Source: org_study_id
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