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临床试验/NCT07827794
NCT07827794尚未招募不适用

The Effect of Preoperative Pelvic Floor Physical Therapy (Prehabilitation) on Postoperative Pain Following Endometriosis Surgery: A Randomized Controlled Trial

University of Alberta1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2027年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
150
试验地点
1
主要终点
Endometriosis Health Profile (EHP)-30 score

研究概览

简要总结

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.

详细描述

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:

  1. Determine the effect of pelvic physiotherapy prehabilitation on quality of life, measured by Endometriosis Health Profile (EHP)-30 scale (primary outcome)
  2. 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).

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
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Control Group

No Intervention

Standard perioperative and surgical care

Intervention Group

Experimental

Structured pre-operative pelvic floor physiotherapy program (prehabilitation) plus standard perioperative and surgical care

干预措施: Structured pre-operative pelvic floor physiotherapy program (prehabilitation) (Other)

结局指标

主要结局

Endometriosis Health Profile (EHP)-30 score

时间窗: 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)

次要结局

  • Chronic pelvic pain(Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively)
  • Dysmenorrhea(Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively)
  • Dyspareunia(Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively)
  • Irritable Bowel Syndrome (IBS)(Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively)
  • Painful bladder syndrome (PBS)(Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively)
  • Central Sensitization Inventory (CSI)(Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively)
  • Pain Catastrophizing Scale (PCS)(Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively)
  • Depression(Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively)
  • Generalized anxiety(Measured prior to surgery and 6-8 weeks post operatively, 6 months and 12 months post operatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alicia Long

Principal Investigator

University of Alberta

研究点 (1)

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