- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02595294
Hypoalgetisk effekt af neural mobilisering
Hypoalgetisk effekt af neural mobilisering i cervicobrachial smerte sammenlignet med en kontrolleret gruppe
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Cervical Lateral Glide (CLG) er en neural vævsmobiliseringsteknik, der er i stand til at opnå en hypoalgetisk effekt under indtræden af cervicobrachiale smertesymptomer. Dette sker gennem en række komplekse fysiologiske interaktioner, som ikke er fuldt ud forstået. CLG Fysioterapi-teknikken består af kontrollerede bevægelser af det cervikale og plexus brachialis neurale væv. Hypoalgetisk effekt produceret af CLG er forbundet med en stigning i neuralt vævsmobilitet, ødem, inflammation og intraneural trykreduktion uden nogen kendte bivirkninger, når de anvendes korrekt, bortset fra en kortvarig forværring af symptomer (den eneste kendte bivirkning af CLG), som er en vigtig kontrast til det brede og til tider alvorlige spektrum af bivirkninger afledt af lægemiddelbehandling, der bruges til at behandle cervicobrachial smerte.
Det antages, at den hypoalgetiske effekt, som mobilisering af neuralt væv giver, er en konsekvens af faldende nervesystems smertemodulationsaktivitet og en forbedring af det involverede neurale vævs særskilte biomekaniske egenskaber. På trods af stigningen i videnskabelig interesse for evidensbaserede muligheder for at behandle smerte og teknikker til mobilisering af neuralt væv er der en aktuel mangel på nok kontrollerede, dobbeltblindede kliniske forsøg, der måler effektiviteten af teknikker til mobilisering af neuralt væv, såsom CLG, og dens specifikke effekt over cervicobrachial smerte. Af denne grund bestod den nuværende undersøgelse i anvendelsen af en behandlingsprotokol baseret på CLG neuralvævsmobilisering i et kontrolleret dobbeltblindt klinisk forsøg med det formål at vurdere dets kliniske effektivitet til behandling af smertesymptomer
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Carabobo
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San Diego, Carabobo, Venezuela, 02006
- "Centro Médico y de Especialidades Pediátricas Dr. José Gregorio Hernández "
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inklusionskriterier:
- Klinisk diagnose af cervicobrachial smerte bekræftet ved magnetisk resonansbilleddannelse
- Tilstedeværelse af ensidige symptomer på armsmerter, paræstesi eller følelsesløshed i den øvre ekstremitet i mindst 3 sammenhængende måneder forud for påføring af behandlingen.
- Positive resultater i alle følgende tests: Spurling, Distraktion og Overekstremitet
Ekskluderingskriterier:
- Kontraindikation ved brug af ikke-steroide antiinflammatoriske lægemidler (NSAID'er)
- Brugen af enhver form for behandling, terapi, procedure eller lægemiddel til at lindre smerter
- Patienter, der er under antikonvulsiv, antidepressiv eller psykotrop medicin
- Vertebral ustabilitet
- Vertebral osteoporose
- Vertebral eller rygsøjleinfektion.
- Neurologiske sygdomme af genetisk, infektiøs eller neoplastisk oprindelse
- Cervikal stenose myelopati
- Graviditet
- Kinesiofobi
- Endokrine lidelser og overgangsalder
- Historie om rygsøjlekirurgi
- Intellektuel funktionsnedsættelse, alvorlig psykisk sygdom, rus, alvorlig søvnmangel, Alzheimers sygdom.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: BEHANDLING
- Tildeling: TILFÆLDIGT
- Interventionel model: PARALLEL
- Maskning: TRIPLE
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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EKSPERIMENTEL: Cervikal lateral glide
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Ikke-kirurgisk ikke-invasiv Cervical Lateral Glide neural mobiliseringsprocedure blev anvendt af en fysioterapeut kontinuerligt i 2 minutter i 5 forskellige lejligheder med 1 minuts hvile mellem hver 2 minutters anvendelse af Neural Mobilization-teknikken.
Interventionen blev anvendt i en periode på 6 uger.
Den korrekte lineære justering af patientens cervikale rygsøjle blev bestemt ved basislinjeanvendelse af en Universal Goniometer Device i hver anvendelse af Cervical Lateral Glide neural mobilisering.
Andre navne:
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NO_INTERVENTION: Venteliste kontrolgruppe
- Patienter tildelt en 6 ugers venteliste for at modtage behandling
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Skift fra baseline ved at bruge den numeriske vurderingsskala for smerte efter 1 time
Tidsramme: ved baseline for begge arme og 1 time efter påføring af behandling kun i forsøgsarmen, svarende til interventionsdag 1, 15 og 30
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den numeriske vurderingsskala for smerte (NRS) er en 11-punktsskala til patientens selvrapportering af smerte, hvor 0 point repræsenterer det totale fravær af smerte og 10 point den værste smertetilstand, den blev brugt til at evaluere tilstedeværelsen og lindring af cervicobrachial smerte symptomer.
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ved baseline for begge arme og 1 time efter påføring af behandling kun i forsøgsarmen, svarende til interventionsdag 1, 15 og 30
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Ændring fra baseline af den fysiske funktion, der involverer det berørte overekstremitet ved hjælp af Quik DASH-skalaen
Tidsramme: ved baseline, svarende til interventionsdag 1 og 30 i behandlingen
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The disabilities of the arm quick test (Quick DASH) er et selvrapporterende kort spørgeskema designet til at måle fysisk funktion og symptomer hos mennesker med en eller flere muskuloskeletale lidelser i overekstremiteterne.
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ved baseline, svarende til interventionsdag 1 og 30 i behandlingen
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Cervical Rotation Range of Motion (CROM)
Tidsramme: ved baseline for begge arme og 1 time efter påføring af behandling kun i forsøgsarmen, svarende til interventionsdag 1 og 30
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Cervikal rotation blev vurderet i enheder af rotationsgrader ved hjælp af den cervikale bevægelsesområde (CROM).
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ved baseline for begge arme og 1 time efter påføring af behandling kun i forsøgsarmen, svarende til interventionsdag 1 og 30
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
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Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CE0072015-2
- CE0072015 (Comite de Bioetica Centro Policlinico la Viña)
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