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

ConditionsEndometriosis Chronic Pelvic Pain Syndrome

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age18-55

SponsorUniversity of Alcala

About this trial

* 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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▪.

Trial design

Design model

Parallel

Treatments tested in this trial

TeleRehab Group
Other intervention
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
Other intervention
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.

Treatment groups

66 Participants

are divided into 2 treatment groups

Group A: TeleRehab GroupExperimental treatment 1 intervention

Group B: Advices GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

Health Status Questionnaire (SF-12)

Change from baseline in quality of life at two month (post-intervention); and 3 and 5 months post-intervention

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.

Visual Numeric Scale (VNS)

Change from baseline in pain at two month (post-intervention); and 3 and 5 months post-intervention

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.

Endometriosis Health Profile (EHP-30)

Change from baseline in endometriosis affectation at two month (post-intervention); and 3 and 5 months post-intervention

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.

Index of Sexual Function (IFSF)

Change from baseline in sexual function at two month (post-intervention); and 3 and 5 months post-intervention

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.

Secondary outcomes

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

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)

Change from baseline in physical activity at two month (post-intervention); and 3 and 5 months post-intervention

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)

Change from baseline in sleep quality at two month (post-intervention); and 3 and 5 months post-intervention

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)

Change from baseline in stress at two month (post-intervention); and 3 and 5 months post-intervention

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.

Other outcomes

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

Time frame

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

Time frame

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.

Time frame

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.

Time frame

Pre-intervention (baseline)

Locations

Map coordinates are unavailable for these locations. Locations are shown below instead.

Physiotherapy in women´s health research group. University of AlcalàRecruiting28871, Alcalà de Henares, Madrid Spain

Spain

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alcala

Lead sponsor

Source ClinicalTrials.gov

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