- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01547624
Neck Muscle Activation in Patients With Long Standing Problems After a Whiplash Trauma Registered With Ultrasound With Speckle Tracking
10 mars 2017 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Förväntat)
60
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Östergötland
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Linköping, Östergötland, Sverige, SE-58183
- Anneli Peolsson
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 63 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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.
Andra namn:
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Inget ingripande: Waiting list
Thirty patients on the waiting list for 3 month before they have their intervention
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Inget ingripande: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Speckle tracking analysis of muscle function
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Background data
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studiestol: Anneli Peolsson, Assoc. Prof., Linkoeping University
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 februari 2011
Primärt slutförande (Faktisk)
1 december 2015
Avslutad studie (Faktisk)
1 december 2015
Studieregistreringsdatum
Först inskickad
28 februari 2012
Först inskickad som uppfyllde QC-kriterierna
4 mars 2012
Första postat (Uppskatta)
8 mars 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
13 mars 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 mars 2017
Senast verifierad
1 mars 2017
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Ultrasound on neck muscles WAD
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
OBESLUTSAM
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