- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03745469
Effekten af smartphonebrugsvarighed hos patienter med kroniske mekaniske nakkesmerter.
Virkninger af smartphonebrugsvarighed på nakkedysfunktion hos unge versus midaldrende patienter med kroniske mekaniske nakkesmerter
FORMÅL: Formålet med denne undersøgelse er at undersøge virkningerne af smartphonebrugsvarighed på nakkesmerter og stillingssans samt Deep Cervical Flexor (DCF) træthed hos unge og midaldrende patienter med kroniske mekaniske nakkesmerter.
BAGGRUND: Nakkesmerter er en af de mest almindelige årsager til muskel- og skeletlidelser med en prævalens på op til 86,8 %. Det kan forstyrre evnen til at udføre normale daglige aktiviteter (ADL). Patienter med nakkesmerter kan have nedsat bevægelsesfrekvens (ROM) og nedsat cervikal positionsfølelse.
Der er mange risikofaktorer, der har været forbundet med nakkesmerter, herunder fysiologiske faktorer såsom alder eller patomekaniske faktorer såsom øget fysisk belastning af rygsøjlen. Smartphonebrug er blevet foreslået som en risikofaktor for udvikling af nakkesmerter hos unge voksne på grund af at opretholde en langvarig statisk stilling eller gentage bestemte nakkebevægelser i lang tid. De negative virkninger af smartphone øges i takt med, at varigheden af brugen øges. Aldring er forbundet med øget cervikal repositionsfejl og reduceret DCF-muskeludholdenhed, men det er ikke klart, hvordan ældre voksne vil reagere på langvarig brug af smartphone.
HYPOTESER: Øget varighed af smartphonebrug vil
- øge nakkesmerter hos midaldrende sammenlignet med unge voksne patienter med kroniske mekaniske.
- mindske cervikal stillingssans hos midaldrende sammenlignet med unge voksne patienter med kroniske mekaniske nakkesmerter.
- øge DCF-træthed hos midaldrende sammenlignet med unge voksne patienter med kroniske mekaniske nakkesmerter.
FORSKNINGSSPØRGSMÅL: Ville øget varighed af smartphonebrug accentuere nakkesmerter, cervikal repositionsfejl og DCF-træthed hos midaldrende sammenlignet med unge voksne med kroniske mekaniske nakkesmerter?
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Patienter med kroniske mekaniske nakkesmerter vil blive instrueret i at bruge en standard smartphone til at surfe på nettet, enten i 10 eller 30 minutter, mens de sidder på en standardstol ved to separate sessioner. Opgavens varighed vil blive testet i en tilfældig rækkefølge genereret af Excel-softwaren.
Resultatmålene for denne undersøgelse vil være nakkesmerter, DCF-træthed og nakkerepositionsfejl. Alle foranstaltninger vil blive vurderet før og umiddelbart efter udførelse af den påkrævede opgave i hver session af en enkelt uddannet bedømmer.
Nakkesmerter vil blive vurderet ved hjælp af den visuelle analoge skala (VAS), proprioceptionsskarphed vil blive kvantificeret ved at måle repositioneringsfejlvinklen ved hjælp af Cervical Range of Motion instrument (CROM), og DCF-udholdenhed vil blive kvantificeret ved hjælp af nakkestabilisatortrykbiofeedback-enheden.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Cairo, Egypten
- The outpatient clinic of the Faculty of Physical Therapy, Cairo University
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Cairo, Egypten
- The outpatient Clinic, kasr Al-Aini Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inklusionskriterier:
- Voksne kvindelige patienter med en alder fra 18 til 60 år.
- Henvist med diagnosen kroniske mekaniske nakkesmerter i mere end 3 måneder.
- Patienter skal have mindst et års erfaring med at bruge touch-screen smartphone.
- Har en nakkefunktionsnedsættelse på mere end 8 % på nakkehandicapindekset (NDI).
Ekskluderingskriterier:
- Enhver historie med skader eller operationer i øvre ekstremiteter inden for det seneste år
- Synsproblemer, svimmelhed og svimmelhed
- Enhver deformitet i de øvre ekstremiteter eller rygsøjlen
- Tidligere rygkirurgi.
- Neurologiske eller systemiske lidelser, der forstyrrer balance og sansning
- Lænderygsmerter eller deformitet.
- Patienter med røde flag såsom malignitet, infektion, betændelse, myelopati.
- Hvis patienten har fysiske problemer med at forstyrre brugen af smartphone, mens han sidder og står.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
Ung aldersgruppe
Patient mellem 18 og 30 år med en bekræftet diagnose af kroniske mekaniske nakkesmerter
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En standard smartphone vil blive brugt til at surfe på internettet i to forskellige varigheder (10 og 30 minutter)
Andre navne:
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Middelaldergruppe
Patienter mellem 30 og 60 år med en bekræftet diagnose af kroniske mekaniske nakkesmerter.
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En standard smartphone vil blive brugt til at surfe på internettet i to forskellige varigheder (10 og 30 minutter)
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Nuværende sværhedsgrad af nakkesmerter
Tidsramme: En uge
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Smerte vil blive målt ved hjælp af Visual Analogue Scale (VAS), som er et validt og pålideligt smertemålingsværktøj. Hver deltager vil blive bedt om at sætte et mærke på en 10 cm vandret linje, der er markeret med 'nul' i den ene ende for at angive ingen smerte og markeret med '10' i den anden ende for at angive maksimal smerte. to separate sessioner, før og umiddelbart efter brug af smartphonen i den angivne periode. |
En uge
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
DCF udholdenhed
Tidsramme: En uge
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DCF-musklernes udholdenhed vil blive vurderet ved hjælp af Neck stabilisator tryk biofeedback.
Dette skal gøres ved to separate sessioner, før og umiddelbart efter brug af smartphonen i den angivne periode.
|
En uge
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Hals proprioception
Tidsramme: En uge
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repositioneringsfejl for nakkefleksion, ekstension og rotation vil blive målt ved hjælp af CROM.
Fejl vil blive beregnet som absolut fejlvinkel.
Dette skal gøres ved to separate sessioner, før og umiddelbart efter brug af smartphonen i den angivne periode.
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En uge
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Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
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