Multimodal Physiotherapy Based on Tele-rehabilitation in Chronic Pelvic Pain Associated With Endometriosis

University of Alcala

Status: Enrolling

Conditions: Chronic Pelvic Pain Syndrome; Endometriosis

Treatments: Other: TeleRehab Group; Other: Advices Group

Study type: Interventional

Funder types: Other

Identifiers

NCT06209346

CEID/2023/6/106

Details and patient eligibility

About

• 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.

Enrollment: 66 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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
• Have any electronic device available (tablet, computer, cell phone).
• Have a current email address.
• Have a valid e-mail address.

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 2 patient groups

TeleRehab Group

Experimental group

Description:

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.

Treatment:

Other: TeleRehab Group

Advices Group

Active Comparator group

Description:

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.

Treatment:

Other: Advices Group