- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01547624
Neck Muscle Activation in Patients With Long Standing Problems After a Whiplash Trauma Registered With Ultrasound With Speckle Tracking
10. März 2017 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Voraussichtlich)
60
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Östergötland
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Linköping, Östergötland, Schweden, SE-58183
- Anneli Peolsson
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 63 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Diagnose
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: 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.
Andere Namen:
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Kein Eingriff: Waiting list
Thirty patients on the waiting list for 3 month before they have their intervention
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Kein Eingriff: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Speckle tracking analysis of muscle function
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Background data
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Studienstuhl: Anneli Peolsson, Assoc. Prof., Linkoeping University
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Februar 2011
Primärer Abschluss (Tatsächlich)
1. Dezember 2015
Studienabschluss (Tatsächlich)
1. Dezember 2015
Studienanmeldedaten
Zuerst eingereicht
28. Februar 2012
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
4. März 2012
Zuerst gepostet (Schätzen)
8. März 2012
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
13. März 2017
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
10. März 2017
Zuletzt verifiziert
1. März 2017
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Ultrasound on neck muscles WAD
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
UNENTSCHIEDEN
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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