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- Ensayo clínico NCT01547624
Neck Muscle Activation in Patients With Long Standing Problems After a Whiplash Trauma Registered With Ultrasound With Speckle Tracking
10 de marzo de 2017 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
60
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Östergötland
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Linköping, Östergötland, Suecia, SE-58183
- Anneli Peolsson
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 63 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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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.
Otros nombres:
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Sin intervención: Waiting list
Thirty patients on the waiting list for 3 month before they have their intervention
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Sin intervención: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Speckle tracking analysis of muscle function
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Background data
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Silla de estudio: Anneli Peolsson, Assoc. Prof., Linkoeping University
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de febrero de 2011
Finalización primaria (Actual)
1 de diciembre de 2015
Finalización del estudio (Actual)
1 de diciembre de 2015
Fechas de registro del estudio
Enviado por primera vez
28 de febrero de 2012
Primero enviado que cumplió con los criterios de control de calidad
4 de marzo de 2012
Publicado por primera vez (Estimar)
8 de marzo de 2012
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
13 de marzo de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
10 de marzo de 2017
Última verificación
1 de marzo de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Ultrasound on neck muscles WAD
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .