- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Alicia Long, MD, MSc, FRCSC
- Telefonní číslo: 1-780-934-5433
- E-mail: ajlong1@ualberta.ca
Studijní záloha kontaktů
- Jméno: Anastasia Sizov, MD
- Telefonní číslo: 1-403-471-2237
- E-mail: sizov@ualberta.ca
Studijní místa
-
-
Alberta
-
Edmonton, Alberta, Kanada
- University of Alberta
-
Kontakt:
- Shauna Littlefair-Beamish, BSc, RN
- Telefonní číslo: 1-780-735-5420
- E-mail: shauna.littlefair-beamish@ahs.ca
-
Vrchní vyšetřovatel:
- Alicia Long, MD, MSc, FRCSC
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Žádný zásah: Control Group
Standard perioperative and surgical care
|
|
|
Experimentální: 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
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Endometriosis Health Profile (EHP)-30 score
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Chronic pelvic pain
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Alicia Long, MD, MSc, FRCSC, University of Alberta
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Urogenitální onemocnění
- Onemocnění genitálií
- Ženské urogenitální onemocnění
- Ženské urogenitální onemocnění a těhotenské komplikace
- Onemocnění pohlavních orgánů, ženy
- Endometrióza
- Motorická aktivita
- Hnutí
- Muskuloskeletální fyziologické jevy
- Muskuloskeletální a nervové fyziologické jevy
- Terapeutika
- Chirurgické postupy, operativní
- Péče o pacienty
- Zdravotní služby
- Zdravotnická zařízení pracovní síla a služby
- Cvičení
- Perioperační péče
- Předoperační cvičení
Další identifikační čísla studie
- 00167703
- Pro00167703 (Jiný identifikátor: ARISE Alberta Research Information Services)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .