- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01547624
Neck Muscle Activation in Patients With Long Standing Problems After a Whiplash Trauma Registered With Ultrasound With Speckle Tracking
10. března 2017 aktualizováno: Anneli Peolsson, Linkoeping University
Today there is evidence for that neck specific exercises reduce neck pain problems in patients with mechanical neck pain.
However, there is a lack of consensus on how to optimize neck exercises and dosages in neck rehabilitation.
More knowledge is needed to determine which and how muscles are activated in exercises thought to be neck-specific.
There is neither enough knowledge of differences in neck muscle activation between patients with long standing neck problems after a whiplash trauma and healthy controls nor if the neck muscle function improved with specific neck exercises.
One approach would be a real time study of deformation and deformation rate in different layers of neck muscles in patients with residual long-term neck pain and disability after a whiplash trauma.
The purpose of the present study was to investigate deformation and deformation rate in different layers of dorsal and ventral neck muscles (including upper and middle part of trapezius muscle) during rest and during different exercises; arm flexion until 120 degrees, repeated arm flexion until 90 degrees, low loaded neck extension, low loaded neck muscle endurance test, shoulder elevation.
Forty patients with long standing (more than 6 months but less than 3 years)patients and 40 controls matched for age and gender will be included for comparisons between patients and healthy in neck muscle activation.
The investigators also include 60 patients with whiplash trauma, of those 30 patients will be randomized to A. neck specific exercises in a 3 months period and B. will 30 be on a waiting list for 3 months.
Measurements are performed at baseline and at 3 months follow-up.
Those patients who fulfilled the 3 months period of neck specific exercises will also be asked for a 6 months follow-up.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Očekávaný)
60
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Östergötland
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Linköping, Östergötland, Švédsko, SE-58183
- Anneli Peolsson
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 63 let (Dospělý)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- WAD II and III
- Age 18-63 years
- Remaining problems
- Right handed
- Pain on right or on both sides.
Exclusion Criteria:
- Myelopathy
- Earlier fracture or luxation of the cervical column, earlier neck injury
- Spinal tumour
- Spinal infection
- Surgery in the cervical column
- Malignity
- Systemic disease or other disease or another injury contraindicated to perform the treatment program or the measurements
- Diagnosed severe psychiatric disorder
- Unconscious in connection to the trauma
- Known drug abuse
- Lack of familiarity with the Swedish language
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Diagnostický
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Neck Specific exercises
3 months of neck specific exercises for 30 patients.
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Neck specific exercises 2 times/week for 3 month at a physiotherapist.
Home exercises.
Ostatní jména:
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Žádný zásah: Waiting list
Thirty patients on the waiting list for 3 month before they have their intervention
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Žádný zásah: Healthy controls
Forty healthy controls.
Comparisons between forty included WAD patients and 40 healthy controls matched for age and gender will be investigated at baseline.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Speckle tracking analysis of muscle function
Časové okno: Baseline and at 3 and 6 months follow-up. The outcome measure is going to report a change over time.
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Measured with medical ultrasonography
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Baseline and at 3 and 6 months follow-up. The outcome measure is going to report a change over time.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Background data
Časové okno: Baseline
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Background data of age, gender, social situation, work, work situation, sick-leave, income, pain history, debute of symptoms, about the accident, earlier treatment, other diseases or pain problems, expectations of treatment
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Baseline
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Symptom satisfaction
Časové okno: Baseline and at 3 months follow-up. The outcome measure is going to report a change over time.
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Baseline and at 3 months follow-up. The outcome measure is going to report a change over time.
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Pain intensity on visual analogue scale (VAS)
Časové okno: Baseline and at 3 months follow-up. The outcome measure is going to report a change over time.
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Symptoms in general, Neck, Arm, Headache
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Baseline and at 3 months follow-up. The outcome measure is going to report a change over time.
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Dizziness/ unsteadiness on visual analogue scale
Časové okno: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
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Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
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Pain distribution on drawing
Časové okno: Baseline and at 3 months follow-up. The outcome measure is going to report a change over time.
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Baseline and at 3 months follow-up. The outcome measure is going to report a change over time.
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Pain Disability Index
Časové okno: Baseline and at 3 months follow-up. The outcome measure is going to report a change over time
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Baseline and at 3 months follow-up. The outcome measure is going to report a change over time
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Neck Disability Index
Časové okno: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
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Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
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Tampa Scale of Kinesiophobia (TSK-11 short version)
Časové okno: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
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Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
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Pain Catastrophizing Scale
Časové okno: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
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Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
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Hospital Anxiety and Depression Scale
Časové okno: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
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Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
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Euroquol
Časové okno: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
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Euroquol 5D and thermometer
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Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
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Exercise Self-Efficacy Scale
Časové okno: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
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"How confident you are to exercise when things get in the way" Exercise self-efficacy scale is a six item scale with a five point scale (1=not at all confident and 5=completely confident).
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Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
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Self-Efficacy Scale
Časové okno: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
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"People´s beliefs about their capabilities to produce designated levels of performance that exercise influence over events that affect their lives" Self-efficacy scale (by Altmaier) is a 20 item, 11 point scale (0=not at all confident, 10=completely confident).
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Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
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Work Ability Index
Časové okno: Baseline and at 3 month follow-up. The outcome is going to report a change over time.
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Baseline and at 3 month follow-up. The outcome is going to report a change over time.
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Physical Activity level
Časové okno: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
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Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
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Physical Outcome Measures
Časové okno: Baseline and at 3 month follow-up. The outcome is going to report a change over time.
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Active range of motion of the neck, Head repositioning accuracy, hand strength, neck muscle endurance, sharpened Romberg, walking in a figure of eight, neurological examination: reflexes, sensibility and motor function
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Baseline and at 3 month follow-up. The outcome is going to report a change over time.
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SF-36
Časové okno: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
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Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Studijní židle: Anneli Peolsson, Assoc. Prof., Linkoeping University
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- Peolsson A, Landen Ludvigsson M, Tigerfors AM, Peterson G. Effects of Neck-Specific Exercises Compared to Waiting List for Individuals With Chronic Whiplash-Associated Disorders: A Prospective, Randomized Controlled Study. Arch Phys Med Rehabil. 2016 Feb;97(2):189-95. doi: 10.1016/j.apmr.2015.10.087. Epub 2015 Oct 26.
- Landen Ludvigsson M, Peterson G, Jull G, Trygg J, Peolsson A. Mechanical properties of the trapezius during scapular elevation in people with chronic whiplash associated disorders--A case-control ultrasound speckle tracking analysis. Man Ther. 2016 Feb;21:177-82. doi: 10.1016/j.math.2015.07.009. Epub 2015 Aug 5.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. února 2011
Primární dokončení (Aktuální)
1. prosince 2015
Dokončení studie (Aktuální)
1. prosince 2015
Termíny zápisu do studia
První předloženo
28. února 2012
První předloženo, které splnilo kritéria kontroly kvality
4. března 2012
První zveřejněno (Odhad)
8. března 2012
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
13. března 2017
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
10. března 2017
Naposledy ověřeno
1. března 2017
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Ultrasound on neck muscles WAD
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NEROZHODNÝ
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 .
Klinické studie na Whiplash Associated Disorder
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Soroka University Medical CenterNeznámý
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Linkoeping UniversityDokončeno
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University Hospitals, LeicesterDokončenoWhiplash Associated DisorderSpojené království
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Kyunghee University Medical CenterUniversity of TsukubaDokončeno
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Hadassah Medical OrganizationClalit Health ServicesNeznámýCervikální bolest | Poruchy spojené s whiplashIzrael
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University of Southern DenmarkNábor
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Korean Pharmacoacupuncture InstituteNeznámý
Klinické studie na Neck specific exercises
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Fondazione Policlinico Universitario Agostino Gemelli...Nábor
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Iran University of Medical SciencesZatím nenabírámeChronická tenzní bolest hlavy