- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03863340
Short Interventions to Prevent Trapezius Muscle Fatigue in Computer Work
Trapezius Muscle Fatigue of Long Duration: a Likely Neuromuscular Control Issue
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
30 healthy adults without chronic neck pain participated in a laboratory study designed to simulate two full workdays of computer work. Within each session, participants performed five 50-min working activities separated by 10-min breaks: i) Use a computer keyboard to type a text presented on the left side of the screen; ii) do the typing task with the desk height set10 cm above elbow height; iii) play the computer game Spider Solitaire implemented in Windows 10; iv) Stroop test (This test consists of reading the name of a color whose text is in a color different from the name. The color name was then selected from a multiple-choice panel displaying color names; v) the same online puzzle game was presented to all participants. Assembling the puzzle was performed by drag and drop actions. The work periods were not disrupted (on the "control day") whereas two short interruptions of 5-min were introduced at 1/3 and 2/3 of each working period on the "intervention day". During these interruptions, participants were asked to perform "muscle disrupting/relaxing" activities. For each experimental session a 30-min lunch break took place between the third and the fourth work periods. The specific sequence of work activity type and disrupting/relaxing activities was randomized across participants; however, for each participant the order of work activities remained the same for the two experimental sessions (control and intervention days). The order of control and intervention days was also randomized between participants.
A set of six measures were performed at specific time intervals during each experiment: before the first work activity, before and after lunch, immediately and 1 hour after the fifth (last) work activity: i) upper trapezius activation, assessed through the temporal EMG profile recorded by a single bipolar signal; and ii) through the spatio-temporal distribution of EMG activity detected by a 2D array of electrodes (64 channels); iii) muscle fatigue, quantified by changes in electrically induced muscle twitch force signals, iv) isometric performance, v) dynamic performance; iii) cognitive and physical load and stress level. In addition, personality traits (anxiety level), perceived workload and musculoskeletal symptoms were evaluated as covariates.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- healthy experienced computer workers
Exclusion Criteria:
- chronic pain (more than 30 days within the last 12 months according to the Nordic Questionnaire (Kuorinka et al 1987);
- pathologies of the neck,
- prior and actual shoulder or neck pain caused by an accident,
- skin disease in the neck or shoulder area,
- BMI > 30,
- sleep disorders (e.g. apnea, restless legs syndrome),
- use of medications such as psychotropic drugs, muscle relaxants or analgesics within the last 3 days prior to the experiment,
- pregnancy.
- any shoulder/neck pain on the day before the experiment.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: short interruptions of work tasks
randomly start with or without short interruptions on the first experimental day and without or with them on the second experimental day
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During each activity two interruptions/breaks were selected randomly from a set of ten predetermined actions: Active break types:
Passive break types:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
EMG profile recorded by a single bipolar electrode: Rest-time
Periodo de tiempo: Continuously from the beginning to 370 min (end) of the simulated working activity of both the control and intervention day
|
Rest-time (percentage of time below 5% of the standard activity level).
The percentage of registration time without any rest time is called sustained low level muscle activity.
|
Continuously from the beginning to 370 min (end) of the simulated working activity of both the control and intervention day
|
|
Spatio-temporal distribution of EMG activity: Area of muscle activity
Periodo de tiempo: Continuously from the beginning to 370 min (end) of the simulated working activity of both the control and intervention day
|
The spatio-temporal distribution of EMG activity is detected by a 2D array of electrodes (64 channels) and the following outcomes are determined: Area of muscle active region (n. of channels) |
Continuously from the beginning to 370 min (end) of the simulated working activity of both the control and intervention day
|
|
Muscle fatigue: Change of muscle twitch
Periodo de tiempo: Change between 30 min before the beginning of the simulated working activity and 30 min after the end of the simulated working activity of both the control and intervention day
|
3-D muscle twitch acceleration pattern measured at the acromion
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Change between 30 min before the beginning of the simulated working activity and 30 min after the end of the simulated working activity of both the control and intervention day
|
|
Muscle fatigue: Change of dynamic force control accuracy
Periodo de tiempo: Change between 30 min before the beginning of the simulated working activity and 30 min after the end of the simulated working activity of both the control and intervention day
|
Force control accuracy (mean squared error between the produced force (N) and the target force (N)) in an isometric dynamic tracking task
|
Change between 30 min before the beginning of the simulated working activity and 30 min after the end of the simulated working activity of both the control and intervention day
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
EMG profile recorded by a single bipolar electrode: Static activity
Periodo de tiempo: Continuously from the beginning to 370 min (end) of the simulated working activity of both the control and intervention day
|
p10 (level of the 10th percentile of the trapezius muscle activity) as an indicator of static activity primarily associated with continuous activity of the same pool of motor units.
|
Continuously from the beginning to 370 min (end) of the simulated working activity of both the control and intervention day
|
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Spatio-temporal distribution of EMG activity: Magnitude of activity
Periodo de tiempo: Continuously from the beginning to 370 min (end) of the simulated working activity of both the control and intervention day
|
The spatio-temporal distribution of EMG activity is detected by a 2D array of electrodes (64 channels) and the following outcomes are determined: Magnitude of activity of muscle active regions (RMS sEMG). |
Continuously from the beginning to 370 min (end) of the simulated working activity of both the control and intervention day
|
|
Spatio-temporal distribution of EMG activity: Number of active epochs
Periodo de tiempo: Continuously from the beginning to 370 min (end) of the simulated working activity of both the control and intervention day
|
The spatio-temporal distribution of EMG activity is detected by a 2D array of electrodes (64 channels) and the following outcomes are determined: Number of active epochs
|
Continuously from the beginning to 370 min (end) of the simulated working activity of both the control and intervention day
|
|
Muscle fatigue: Change of static force control
Periodo de tiempo: Change between 30 min before the beginning of the simulated working activity and 30 min after the end of the simulated working activity of both the control and intervention day
|
Force control accuracy (mean squared error between the produced force (N) and the target force (N)) in isometric isotonic low level contraction
|
Change between 30 min before the beginning of the simulated working activity and 30 min after the end of the simulated working activity of both the control and intervention day
|
|
Muscle fatigue: Change of force control in ramp contraction
Periodo de tiempo: Change between 30 min before the beginning of the simulated working activity and 30 min after the end of the simulated working activity of both the control and intervention day
|
Force control accuracy (mean squared error between the produced force (N) and the target force (N)) in isometric ramp contraction.
|
Change between 30 min before the beginning of the simulated working activity and 30 min after the end of the simulated working activity of both the control and intervention day
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Localized musculoskeletal discomfort
Periodo de tiempo: At the start, and 70min, 130min, 190min, 310min, 370 min after the beginning of the simulated working activity of both the control and intervention day
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head-neck-shoulders-lower back-elbows-wrists-hip-upper legs-knees-ankles-feet-discomfort rated on 10 cm visual analog scales (adapted from Nordic questionnaire (Kuorinka et al 1987)
|
At the start, and 70min, 130min, 190min, 310min, 370 min after the beginning of the simulated working activity of both the control and intervention day
|
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Visual and general fatigue
Periodo de tiempo: At the start, and 70min, 130min, 190min, 310min, 370 min after the beginning of the simulated working activity of both the control and intervention day
|
10 cm visual analog scales
|
At the start, and 70min, 130min, 190min, 310min, 370 min after the beginning of the simulated working activity of both the control and intervention day
|
|
Effort
Periodo de tiempo: At the start, and 70min, 130min, 190min, 310min, 370 min after the beginning of the simulated working activity of both the control and intervention day
|
6-20 Borg scale (6= no effort, 20=maximal possible effort)
|
At the start, and 70min, 130min, 190min, 310min, 370 min after the beginning of the simulated working activity of both the control and intervention day
|
|
EMG profile recorded by a single bipolar electrode: Dynamic activity
Periodo de tiempo: Continuously from the beginning to 370 min (end) of the simulated working activity of both the control and intervention day
|
p90 (level of the 90th percentile of the trapezius muscle activity) as an indicator of dynamic activity which may promote variability in the recruitment of motor units
|
Continuously from the beginning to 370 min (end) of the simulated working activity of both the control and intervention day
|
|
Spatio-temporal distribution of EMG activity: Centroid of active regions
Periodo de tiempo: Continuously from the beginning to 370 min (end) of the simulated working activity of both the control and intervention day
|
The spatio-temporal distribution of EMG activity is detected by a 2D array of electrodes (64 channels) and the following outcomes are determined: Centroid of active regions
|
Continuously from the beginning to 370 min (end) of the simulated working activity of both the control and intervention day
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Thomas Läubli, MD, Federal Institute of Technology Zurich
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 32003B_160207
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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