- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07827794
The Effect of Preoperative Pelvic Floor Physical Therapy (Prehabilitation) on Postoperative Pain Following Endometriosis Surgery: A Randomized Controlled Trial
Endometriosis is a chronic inflammatory condition where there is abnormal tissue growing in the pelvis or other places in the body that resembles the lining of the uterus (endometrium), and is a common cause of long lasting pelvic pain. Surgery is sometimes done for endometriosis to help people with pain, however it is common for people to have some pain after surgery that doesn't go away. This may be related to other painful things like muscle pain in the pelvis, bowel or bladder issues, or mental health conditions.
Researchers would like to know if doing pelvic floor physiotherapy before surgery for endometriosis will help people with long lasting pain after surgery.
Participants in the study will be randomly put into one of two groups: the intervention group, who will receive two to three structured in-person pelvic floor physiotherapy sessions prior to surgery ("prehabilitation"), in addition to usual surgical care, or the control group, who will receive usual surgical care, and may still access physiotherapy outside of the study if they want to. All participants will complete questionnaires before surgery, after completing prehabilitation or immediately before surgery if they are part of the control group, approximately 6 weeks after surgery, 6 months after surgery, and 12 months after surgery. The questionnaires ask about endometriosis-related pain, quality of life, bladder and bowel symptoms, and mental well-being.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Introduction: Endometriosis is a chronic inflammatory gynecologic condition characterized by growth of ectopic endometrial-like tissue within and outside of the pelvis, and is a common cause of chronic pelvic pain. Surgical management, including fertility-sparing endometriosis surgery or hysterectomy, is frequently performed with the goal of improving pain and quality of life; however, persistent or recurrent pain after endometriosis surgery is not uncommon. Factors contributing to ongoing pain may include conditions that are present before surgery including myofascial pelvic pain, psychological factors, or the presence of other comorbid chronic pain conditions, sometimes culminating in complex pain syndromes and central nervous system sensitization. "Prehabilitation", defined a structured intervention such as physiotherapy, exercise, and dietary changes, have been shown to improve perioperative outcomes in several surgical specialties, including gynecologic oncology, colorectal surgery, and orthopedic surgery. Pelvic floor physiotherapy has been shown to improve endometriosis-related pain symptoms and functional outcomes. Despite indirect data showing benefits, the quantitative and qualitative effect of prehabilitation in individuals undergoing endometriosis surgery for pelvic pain remains unknown.
Aim: To investigate the impact of structured preoperative pelvic physiotherapy in patients with pelvic pain undergoing endometriosis surgery (fertility sparing surgery and hysterectomy)
Objectives:
- Determine the effect of pelvic physiotherapy prehabilitation on quality of life, measured by Endometriosis Health Profile (EHP)-30 scale (primary outcome)
- Examine the impact of pelvic physiotherapy prehabilitation on chronic pelvic, dysmenorrhea, dyspareunia, symptoms of irritable bowel syndrome (IBS) and painful bladder syndrome (PBS), and psychologic indices including depression, anxiety and pain catastrophizing (secondary outcomes) Hypothesis: Patients receiving structured preoperative pelvic floor physiotherapy ("prehabilitation") will have improved post-operative pain scores and improved quality of life compared to those receiving standard care.
Methods: This study is a prospective, single-center, double arm, non-blinded randomized controlled trial evaluating the effect of preoperative pelvic floor physiotherapy ("prehabilitation") on pre- and post- operative pain and quality of life outcomes in patients with pelvic pain undergoing surgery for endometriosis (fertility sparing or hysterectomy). Participants aged 18-50 will be screened for eligibility from the Chronic Pelvic Pain (CPP) clinic in Edmonton, Alberta at the Lois Hole Hospital for Women. Eligible and willing participants will undergo randomization in a 1:1 ratio to receive either structured preoperative pelvic floor physiotherapy (2-3 sessions within 6 months leading up to surgery), in addition to standard perioperative care (intervention group) or standard perioperative care alone (control group). Surgery will be performed by fellowship trained minimally invasive gynecologic surgeons at the Royal Alexandra Hospital in Edmonton, AB. Participants will complete questionnaires at baseline, after prehabilitation is complete before surgery, 6-8 weeks post operatively, and 6 months and 12 months post operatively. Baseline demographic information will be collected including age, BMI, gynecologic surgical history, hormone use, and analgesic use. The primary outcome measure of this study is the Endometriosis Health Profile (EHP)-30 score (measures quality of life) over these timepoints. Secondary outcomes include measurements of chronic pelvic pain, dysmenorrhea, dyspareunia (numerical rating scale), presence of IBS and PBS, Central Sensitization Inventory (CSI), Pain Catastrophizing Scale (PCS), and assessment for depression through the Patient Health Questionnaire-9 (PHQ-9), and presence of generalized anxiety disorder through the GAD-7 questionnaire. Data will be stratified by the type of surgery patients received (hysterectomy or fertility-sparing endometriosis surgery) and stage of endometriosis (stage I/II or stage III/IV).
Expected outcomes and significance: If effective, preoperative pelvic floor physiotherapy may represent a low-risk intervention to improve overall pain and quality of life in patients undergoing endometriosis surgery. Findings could inform the creation of standardized care pathways for patients seeking care for chronic pelvic pain, improve outcomes in patients undergoing surgery for endometriosis, and decrease healthcare utilization after surgery which could have a major positive economic impact as well.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Alicia Long, MD, MSc, FRCSC
- Номер телефона: 1-780-934-5433
- Электронная почта: ajlong1@ualberta.ca
Учебное резервное копирование контактов
- Имя: Anastasia Sizov, MD
- Номер телефона: 1-403-471-2237
- Электронная почта: sizov@ualberta.ca
Места учебы
-
-
Alberta
-
Edmonton, Alberta, Канада
- University of Alberta
-
Контакт:
- Shauna Littlefair-Beamish, BSc, RN
- Номер телефона: 1-780-735-5420
- Электронная почта: shauna.littlefair-beamish@ahs.ca
-
Главный следователь:
- Alicia Long, MD, MSc, FRCSC
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Presence of chronic pelvic pain (>6 months)
- Diagnosis of endometriosis (clinical, laparoscopic, or imaging-based diagnosis)
- Scheduled for fertility-sparing endometriosis surgery or hysterectomy with excision of endometriosis
Exclusion Criteria:
- Undergoing gynecologic surgery in the absence of pelvic pain
- Patients undergoing laparotomy or conversion to laparotomy
- Have undergone endometriosis related surgery in the past 12 months
- Have engaged in pelvic physiotherapy in the past 12 months
- Non-English speakers (if validated tools unavailable)
- Active malignancy
- Post-menopausal
- Prior oophorectomy
- Prior hysterectomy
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Без вмешательства: Control Group
Standard perioperative and surgical care
|
|
|
Экспериментальный: Intervention Group
Structured pre-operative pelvic floor physiotherapy program (prehabilitation) plus standard perioperative and surgical care
|
Two to three structured pre-operative pelvic floor physiotherapy program (prehabilitation) by physiotherapist specializing in chronic pelvic pain
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Endometriosis Health Profile (EHP)-30 score
Временное ограничение: Endometriosis Health Profile (EHP)-30 score measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
|
Endometriosis Health Profile (EHP)-30 score (validated questionnaire measuring pain and quality of life)
|
Endometriosis Health Profile (EHP)-30 score measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Chronic pelvic pain
Временное ограничение: Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
|
Chronic pelvic pain measured by numeric rating scale
|
Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
|
|
Dysmenorrhea
Временное ограничение: Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
|
Dysmenorrhea measured by numeric rating scale
|
Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
|
|
Dyspareunia
Временное ограничение: Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
|
Dyspareunia measured by numeric rating scale
|
Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
|
|
Irritable Bowel Syndrome (IBS)
Временное ограничение: Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
|
Presence or absence of IBS
|
Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
|
|
Painful bladder syndrome (PBS)
Временное ограничение: Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
|
Presence or absence of PBS
|
Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
|
|
Central Sensitization Inventory (CSI)
Временное ограничение: Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
|
Central sensitization score measured by CSI (validated questionnaire)
|
Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
|
|
Pain Catastrophizing Scale (PCS)
Временное ограничение: Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
|
PCS score (validated questionnaire)
|
Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
|
|
Depression
Временное ограничение: Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
|
Depression as measured by PHQ-9 score
|
Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
|
|
Generalized anxiety
Временное ограничение: Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
|
Generalized anxiety as measured by GAD-7 questionnaire
|
Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Alicia Long, MD, MSc, FRCSC, University of Alberta
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Урогенитальные заболевания
- Генитальные заболевания
- Женские урогенитальные заболевания
- Женские мочеполовые заболевания и осложнения беременности
- Заболевания половых органов, Женский
- Эндометриоз
- Моторная активность
- Движение
- Компания скелетно -скелетно -мышечности
- Скелетно -скелетно -нейронные физиологические явления
- Терапия
- Хирургические процедуры, оперативные
- Уход за пациентами
- Медицинские услуги
- Медицинские учреждения рабочей силы и услуги
- Упражнение
- Периоперационная помощь
- Предоперационные упражнения
Другие идентификационные номера исследования
- 00167703
- Pro00167703 (Другой идентификатор: ARISE Alberta Research Information Services)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .