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

Обзор

* 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.

Вмешательства

• Другое 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 f
• Другое 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.

Первичные конечные точки

• Health Status Questionnaire (SF-12) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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.]

Вторичные конечные точки (6)

• Hospital Anxiety and Depression Scale (HADS) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: Pre-intervention (baseline); Post-intervention (two month from baseline); and 3 and 5 months post-intervention]
• Patient global impression of change (PGI-I) [Срок оценки: 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.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Physiotherapy in women´s health research group. University of Alcalà — Alcalà de Henares

Идентификаторы

NCT: NCT06209346 · CEID/2023/6/106

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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