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

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06209346
• Other study ID #: CEID/2023/6/106
• Status: Recruiting
• Phase: N/A
• Start date: November 27, 2023
• Est. completion date: January 17, 2027

Study information

• Verified date: July 2023
• Source: University of Alcala
• Contact: María Torres-Lacomba, PhD
• Phone: 918856875
• Email: maria.torres[@]uah.es
• Is FDA regulated: No
• Study type: Interventional

Clinical 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), 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: January 17, 2027
• Est. primary completion date: January 17, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pelvic Pain Syndrome
• Endometriosis
• Pelvic Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Physiotherapy in women´s health research group. University of Alcalà	Alcalà de Henares	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
University of Alcala

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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
Primary	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	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
Secondary	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
Secondary	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).
Secondary	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.
Secondary	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
Secondary	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.