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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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

Primary outcome measure(s)

• Health Status Questionnaire (SF-12) — 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.
  Change from baseline in quality of life at two month (post-intervention); and 3 and 5 months post-intervention
• Visual Numeric Scale (VNS) — 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.
  Change from baseline in pain at two month (post-intervention); and 3 and 5 months post-intervention
• Endometriosis Health Profile (EHP-30) — 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.
  Change from baseline in endometriosis affectation at two month (post-intervention); and 3 and 5 months post-intervention
• Index of Sexual Function (IFSF) — 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.
  Change from baseline in sexual function at two month (post-intervention); and 3 and 5 months post-intervention
• Tampa Scale of Kinesiophobia (TSK) — 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
  Change from baseline in kinesiophobia at two month (post-intervention); and 3 and 5 months post-intervention
• Pain Catastrophizing Scale (PCS) — 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.
  Change from baseline in catastrophixing at two month (post-intervention); and 3 and 5 months post-intervention

Trial sites (1)

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