* 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
66
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.
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.
Physiotherapy in women´s health research group. University of Alcalà
Alcalà de Henares, Madrid, Spain
RECRUITINGHealth 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.
Tampa Scale of Kinesiophobia (TSK)
Change from baseline in kinesiophobia 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 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
Time frame: 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.
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.
Patient's adherence will be evaluated
Adherence (via TRAK Platform with email and chat)
Time frame: 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)
Time frame: 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.
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