Multimodal Physiotherapy Based on Tele-rehabilitation in Chronic Pelvic Pain Associated With Endometriosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Health Status Questionnaire (SF-12)
研究概览
简要总结
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Health Status Questionnaire (SF-12)
时间窗: 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
Index of Sexual Function (IFSF)
时间窗: 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)
时间窗: 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
Visual Numeric Scale (VNS)
时间窗: 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
Pain Catastrophizing Scale (PCS)
时间窗: 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
Endometriosis Health Profile (EHP-30)
时间窗: 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
次要结局
- Pittsburg Sleep Quality Index (PSQI)(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).)
- Patient's adherence will be evaluated(Pre-intervention (baseline); Post-intervention (two month from baseline); and 3 and 5 months post-intervention)
- Patient global impression of change (PGI-I)(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.)
- Hospital Anxiety and Depression Scale (HADS)(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)(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)
- Perceived Stress Scale (PSS)(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.)
研究者
Maria Torres Lacomba
Professor
University of Alcala