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

• 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 Overview

• Status: Recruiting
• Conditions: Endometriosis; Chronic Pelvic Pain Syndrome
• Intervention / Treatment: Other: TeleRehab Group; Other: Advices Group

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: María Torres-Lacomba, PhD; Phone Number: 918856875; Email: maria.torres@uah.es

Study Locations

• Spain
  • Madrid
    • Alcalà de Henares, Madrid, Spain, 28871
      • Recruiting
      • Physiotherapy in women´s health research group. University of Alcalà
      • Contact: María Torres-Lacomba, PhD; Email: maria.torres@uah.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.; Other Names: TrhbG
Active Comparator: 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.	Other: 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 Names: AG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health Status Questionnaire (SF-12)	Change from baseline in quality of life at two month (post-intervention); and 3 and 5 months post-intervention	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	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	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	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	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	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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)	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)	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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass index (BMI)	BMI can give a general idea of whether a person is at a healthy weight and It is important to know how this relates to endometriosis and pain	Pre-intervention (baseline); Post-intervention (two month from baseline); and 3 and 5 months post-intervention.
Employment status	It is important to know the patient's current work status for her medical history and how this relates to endometriosis and pain	Pre-intervention (baseline)
Education level	It is important to know the patient's educational level for her medical history and how this relates to endometriosis and pain.	Pre-intervention (baseline)
Ethnicity	It is important to know the patient's ethnicity for her medical history and how this relates to endometriosis and pain.	Pre-intervention (baseline)
Maritial status	It is important to know the patient's marital status for her medical history and how this relates to endometriosis and pain.	Pre-intervention (baseline)
Number of children	It is important to know if and how many children the patient has for her medical history and how this relates to endometriosis and pain.	Pre-intervention (baseline)
Age	It is important to know the patient's age for her medical history and how this relates to endometriosis and pain.	Pre-intervention (baseline); Post-intervention (two month from baseline); and 3 and 5 months post-intervention.

Collaborators and Investigators

• Sponsor: University of Alcala

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2023
• Primary Completion (Estimated): January 17, 2025
• Study Completion (Estimated): January 17, 2027

Study Registration Dates

• First Submitted: December 5, 2023
• First Submitted That Met QC Criteria: January 7, 2024
• First Posted (Actual): January 17, 2024

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 7, 2024
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: physical therapy; endometriosis; pain education; chronic pelvic pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Endometriosis; Pelvic Pain
• Other Study ID Numbers: CEID/2023/6/106

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No