Clinical trial NCT06209346: Multimodal Physiotherapy Based on Tele-rehabilitation in Chronic Pelvic Pain Associated With Endometriosis
Official title: Multimodal Physiotherapy Based on Tele-rehabilitation in Chronic Pelvic Pain Associated With Endometriosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Endometriosis
Chronic Pelvic Pain Syndrome
Keywords: endometriosis
chronic pelvic pain
physical therapy
pain education
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Health Status Questionnaire (SF-12)
timeFrame: 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.
measure: Visual Numeric Scale (VNS)
timeFrame: 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.
measure: Endometriosis Health Profile (EHP-30)
timeFrame: 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.
measure: Index of Sexual Function (IFSF)
timeFrame: 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.
measure: Tampa Scale of Kinesiophobia (TSK)
timeFrame: 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
measure: Pain Catastrophizing Scale (PCS)
timeFrame: 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 outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 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
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: 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
measure: Pittsburg Sleep Quality Index (PSQI)
timeFrame: 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).
measure: Perceived Stress Scale (PSS)
timeFrame: 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.
measure: Patient's adherence will be evaluated
timeFrame: Pre-intervention (baseline); Post-intervention (two month from baseline); and 3 and 5 months post-intervention
measure: Patient global impression of change (PGI-I)
timeFrame: 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 outcomes:
measure: Body mass index (BMI)
timeFrame: Pre-intervention (baseline); Post-intervention (two month from baseline); and 3 and 5 months post-intervention.
measure: Employment status
timeFrame: Pre-intervention (baseline)
measure: Education level
timeFrame: Pre-intervention (baseline)
measure: Ethnicity
timeFrame: Pre-intervention (baseline)
measure: Maritial status
timeFrame: Pre-intervention (baseline)
measure: Number of children
timeFrame: Pre-intervention (baseline)
measure: Age
timeFrame: Pre-intervention (baseline); Post-intervention (two month from baseline); and 3 and 5 months post-intervention.
Locations:
city: Alcalà de Henares
country: Spain
facility: Physiotherapy in women´s health research group. University of Alcalà
state: Madrid
Study officials:
References: