- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Alicia Long, MD, MSc, FRCSC
- 전화번호: 1-780-934-5433
- 이메일: ajlong1@ualberta.ca
연구 연락처 백업
- 이름: Anastasia Sizov, MD
- 전화번호: 1-403-471-2237
- 이메일: sizov@ualberta.ca
연구 장소
-
-
Alberta
-
Edmonton, Alberta, 캐나다
- University of Alberta
-
연락하다:
- Shauna Littlefair-Beamish, BSc, RN
- 전화번호: 1-780-735-5420
- 이메일: shauna.littlefair-beamish@ahs.ca
-
수석 연구원:
- Alicia Long, MD, MSc, FRCSC
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
간섭 없음: Control Group
Standard perioperative and surgical care
|
|
|
실험적: 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
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Endometriosis Health Profile (EHP)-30 score
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Chronic pelvic pain
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Alicia Long, MD, MSc, FRCSC, University of Alberta
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 00167703
- Pro00167703 (기타 식별자: ARISE Alberta Research Information Services)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .