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Neck Muscle Activation in Patients With Long Standing Problems After a Whiplash Trauma Registered With Ultrasound With Speckle Tracking

10. marts 2017 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Östergötland
      • Linköping, Östergötland, Sverige, SE-58183
        • Anneli Peolsson

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

18 år til 63 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Neck Specific exercises
3 months of neck specific exercises for 30 patients.
Neck specific exercises 2 times/week for 3 month at a physiotherapist. Home exercises.
Andre navne:
  • Physiotherapy with neck specific exercises
Ingen indgriben: Waiting list
Thirty patients on the waiting list for 3 month before they have their intervention
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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.
Measured with medical ultrasonography
Baseline and at 3 and 6 months follow-up. The outcome measure is going to report a change over time.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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
Baseline
Symptom satisfaction
Tidsramme: Baseline and at 3 months follow-up. The outcome measure is going to report a change over time.
Baseline and at 3 months follow-up. The outcome measure is going to report a change over time.
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.
Symptoms in general, Neck, Arm, Headache
Baseline and at 3 months follow-up. The outcome measure is going to report a change over time.
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.
Pain distribution on drawing
Tidsramme: Baseline and at 3 months follow-up. The outcome measure is going to report a change over time.
Baseline and at 3 months follow-up. The outcome measure is going to report a change over time.
Pain Disability Index
Tidsramme: Baseline and at 3 months follow-up. The outcome measure is going to report a change over time
Baseline and at 3 months follow-up. The outcome measure is going to report a change over time
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.
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.
Pain Catastrophizing 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.
Hospital Anxiety and Depression 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.
Euroquol
Tidsramme: Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
Euroquol 5D and thermometer
Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
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).
Baseline and at 3 month follow-up. The outcome measure is going to report a change over time.
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.
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.
Physical Activity level
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.
Physical Outcome Measures
Tidsramme: Baseline and at 3 month follow-up. The outcome is going to report a change over time.
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
Baseline and at 3 month follow-up. The outcome is going to report a change over time.
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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Studiestol: Anneli Peolsson, Assoc. Prof., Linkoeping University

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.

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

1. februar 2011

Primær færdiggørelse (Faktiske)

1. december 2015

Studieafslutning (Faktiske)

1. december 2015

Datoer for studieregistrering

Først indsendt

28. februar 2012

Først indsendt, der opfyldte QC-kriterier

4. marts 2012

Først opslået (Skøn)

8. marts 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. marts 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. marts 2017

Sidst verificeret

1. marts 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Ultrasound on neck muscles WAD

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Whiplash associeret lidelse

Kliniske forsøg med Neck specific exercises

3
Abonner