- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01547624
Neck Muscle Activation in Patients With Long Standing Problems After a Whiplash Trauma Registered With Ultrasound With Speckle Tracking
10. mars 2017 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Forventet)
60
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Östergötland
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Linköping, Östergötland, Sverige, SE-58183
- Anneli Peolsson
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 63 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
Andre navn:
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Ingen inngripen: Waiting list
Thirty patients on the waiting list for 3 month before they have their intervention
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Ingen inngripen: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Speckle tracking analysis of muscle function
Tidsramme: 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.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Background data
Tidsramme: Baseline
|
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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
|
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
|
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)
Tidsramme: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
|
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
|
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
Tidsramme: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
|
"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
Tidsramme: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
|
"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).
|
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
Tidsramme: Baseline and at 3 month follow-up. The outcome is going to report a change over time.
|
Baseline and at 3 month follow-up. The outcome is going to report a change over time.
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Physical Activity level
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
|
Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studiestol: Anneli Peolsson, Assoc. Prof., Linkoeping University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. februar 2011
Primær fullføring (Faktiske)
1. desember 2015
Studiet fullført (Faktiske)
1. desember 2015
Datoer for studieregistrering
Først innsendt
28. februar 2012
Først innsendt som oppfylte QC-kriteriene
4. mars 2012
Først lagt ut (Anslag)
8. mars 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
13. mars 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. mars 2017
Sist bekreftet
1. mars 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Ultrasound on neck muscles WAD
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
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