- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05750212
Muskel- og bækkenbundssundhed ved kroniske overlappende bækkensmerter hos kvinder
6. marts 2025 opdateret af: Colleen M. Fitzgerald, MD, MS, Loyola University
Muskuloskeletal og bækkenbundssundhed i kvindelige kroniske overlappende bækkensmertetilstande (MSK-PELVIC-undersøgelsen)
Formålet med denne undersøgelse er at lære om nervefunktion og bækkenmuskelfunktion.
For at gøre dette vil vi sammenligne bækkennerve- og muskelfunktionen hos kvinder med kroniske bækkensmerter med dem, der ikke har kroniske bækkensmerter.
At forstå smerten kan føre til bedre behandlinger i fremtiden.
Studieoversigt
Status
Rekruttering
Betingelser
Detaljeret beskrivelse
Kroniske bækkensmerter (CPP) kan påvirke op til en fjerdedel af alle kvinder.
Traditionelt har man troet, at CPP er drevet af viscerale smertemekanismer såsom interstitiel blærebetændelse/smertefuld blæresyndrom (IC/PBS), irritabel tyktarm (IBS) og endometriose.
Det er også fastslået, at disse viscerale smertetilstande overlapper med vulvodyni, fibromyalgi, depression og angst.
For nylig er underliggende bækkenbundsmyofascial (PFMP) og dyssynergi blevet identificeret som yderligere overlappende CPP-tilstande.
Tidligere arbejde tyder på, at PFMP kan være en viscerosomatisk reaktion, men PFMP som en kompenserende konsekvens af andre regionale muskuloskeletale (MSK) tilstande er også blevet foreslået.
På tværs af deres levetid står kvinder faktisk over for højere risici end mænd for et væld af MSK-skader og kroniske MSK-tilstande, herunder en øget forekomst af sportsrelaterede skader, ledhypermobilitet, fibromyalgi, slidgigt (postmenopause) og osteoporose/osteoporose -associerede brud.
Disse forhøjede risici menes at skyldes de unikke anatomiske (strukturelle), biomekaniske og hormonelle faktorer, der kan tilskrives den fysiologiske proces med graviditet og aldring.
Den nuværende ansøgning har til formål at adressere det betydelige vidensgab vedrørende den begrænsede forståelse af den neuromuskulære funktion af PFM i CPP såvel som rollen af overlappende MSK-tilstande og MSK-sundhed, der kan påvirke PFM-respons.
Det kortsigtede mål er at undersøge PFM-biomekanik ved at identificere de mest præcise muskelmålinger hos kvinder med CPP af forskellige overlappende diagnoser sammenlignet med asymptomatiske kontroller, sammen med vurdering af overordnet MSK sundhed/fysisk aktivitet.
Det langsigtede mål er at bestemme MSK bækkensmertemekanismer, der vil informere klinisk relevant klassificering, udvikle evidensbaserede ikke-farmakologiske (fysisk terapi/motion) behandlinger til kvinder med CPP og fremme forskningsværktøjer inden for området PFM-funktion og CPP da det relaterer sig til det overordnede MSK-sundhed.
Vores innovative strategi kombinerer neuromuskulære målinger ved hjælp af nye enheder og validerede målinger til evaluering af CPP, MSK sundhed og fysisk aktivitet.
Vores centrale hypotese er, at kvinder med CPP vil demonstrere kvantificerbare PFM-abnormiteter og kliniske MSK-karakteristika, der adskiller sig fra asymptomatiske kontroller.
Resultaterne fra denne undersøgelse vil have en betydelig indvirkning på folkesundheden med bidrag fra strenge objektive og omfattende PFM- og MSK-metoder, som vil være velegnede til fremtidige NIH-kliniske forskningsnetværk/-forsøg, for at evaluere og vurdere MSK-bidraget og potentielle behandlingsresultater hos kvinder med CPP.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
208
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Mary J Tulke, RN
- Telefonnummer: 7082162067
- E-mail: mtulke@luc.edu
Undersøgelse Kontakt Backup
- Navn: Colleen Fitzgerald, MD
- Telefonnummer: 7082163387
- E-mail: cfitzgerald@lumc.edu
Studiesteder
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Illinois
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Maywood, Illinois, Forenede Stater, 60153
- Rekruttering
- Loyola Medical Center
-
Kontakt:
- Mary Tulke, RN
- Telefonnummer: 7082162067
- E-mail: mtulke@luc.edu
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
21 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Deltagerne er udvalgt fra et tertiært medicinsk center
Beskrivelse
Inklusionskriterier:
- Kvindelig køn
- Alder 21 til 80 år
- Symptomer på CPP som defineret af American College of Obstetrics & Gynecology (ACOG) i mere end 6 måneder
- Mindst to af syv overlappende CPP-diagnoser (dvs. IC/PBS, IBS, Endometriose, Vulvodynia, PN, FM, PFMP)
- En gennemsnitlig CPP smertescore på mindst tre på en 10-punkts smerteskala
Ekskluderingskriterier:
- Aktuel eller historie med GI eller GU bækkenkræft
- Aktuel bækkeninfektion (f.eks. en UVI eller vaginal infektion)
- Aktuel eller forestående planlagt graviditet eller nylig fødsel inden for de sidste 6 måneder
- Abdominal- eller bækkenoperation inden for de sidste 36 måneder.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
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Sager
Cases er voksne kvindelige patienter med diagnosen bækkenbundsforstyrrelse.
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Tone er en binær måling af bækkenbundsmusklen ved fysisk undersøgelse
Ømhed er en binær måling af bækkenbundsmusklen ved fysisk undersøgelse
Kontraktion er en binær måling af bækkenbundsmusklen ved fysisk undersøgelse
Afspænding er en binær måling af bækkenbundsmusklen ved fysisk undersøgelse
Elektromyografi er en måling af bækkenbundsmusklen i mikrovolt
Transperineale målinger (i millimeter) af bækkenbundsmusklen ved hjælp af en ultralyd
Trykmålinger (i millimeter) af bækkenbundsmusklen ved hjælp af et algometer
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Kontrolelementer
Kontroller er voksne kvindelige patienter udtaget fra et ambulant primært plejecenter
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Tone er en binær måling af bækkenbundsmusklen ved fysisk undersøgelse
Ømhed er en binær måling af bækkenbundsmusklen ved fysisk undersøgelse
Kontraktion er en binær måling af bækkenbundsmusklen ved fysisk undersøgelse
Afspænding er en binær måling af bækkenbundsmusklen ved fysisk undersøgelse
Elektromyografi er en måling af bækkenbundsmusklen i mikrovolt
Transperineale målinger (i millimeter) af bækkenbundsmusklen ved hjælp af en ultralyd
Trykmålinger (i millimeter) af bækkenbundsmusklen ved hjælp af et algometer
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Forskel på to modtagers driftskarakteristiske kurver
Tidsramme: 0 dage
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Deltaværdien mellem to diagnostiske nøjagtighedsstatistikker (c-statistik) vil blive rapporteret med dets 95 % konfidensinterval og signifikansværdi (p-værdi).
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0 dage
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Colleen Fitzgerald, MD, Loyola Medical Center
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
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Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
24. januar 2023
Primær færdiggørelse (Anslået)
24. september 2025
Studieafslutning (Anslået)
24. oktober 2025
Datoer for studieregistrering
Først indsendt
20. januar 2023
Først indsendt, der opfyldte QC-kriterier
20. februar 2023
Først opslået (Faktiske)
1. marts 2023
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
25. marts 2025
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. marts 2025
Sidst verificeret
1. marts 2025
Mere information
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Andre undersøgelses-id-numre
- 213778
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