- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07609173
Immediate Effects of Shock Wave Therapy With Stretching or Isometric Contraction on Upper Trapezius (rESWT)
The Immediate Effects of Simultaneous Application of Radial Extracorporeal Shock Wave Therapy and Stretching or Isometric Contraction on Muscle Tone, Stiffness, Thickness, Pressure Pain Threshold, and Grip Strength of the Upper Trapezius
Excessive use of smart devices and prolonged sitting posture in modern daily life can lead to potential hypertonicity and functional impairment of the upper trapezius even in healthy individuals. Such conditions may cause functional changes and discomfort before the onset of pain, and early intervention may help prevent the progression to musculoskeletal disorders. Therefore, this study aims to investigate the immediate effects of radial extracorporeal shock wave therapy (rESWT) applied simultaneously with stretching or isometric contraction on muscle tone, stiffness, thickness, pressure pain threshold, and grip strength of the upper trapezius in healthy adults.
Participants will be divided into two groups : rESWT + stretching and rESWT + isometric contraction. Immediate changes in the upper trapezius will be compared before and after the interventions. rESWT will be applied to the upper trapezius with 1.0 bar pressure, 10 Hz frequency, and 1000 shocks.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Gwangju, Corea del Sur, 62287
- 73, Bungmun-daero 419beon-gil, Gwangju health university
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Individuals with no history of neck or shoulder pain in the past 6 months
- Individuals with no history of upper limb musculoskeletal disorders
- Individuals with a pressure pain threshold (PPT) of the upper trapezius ≥ 263 kPa
Exclusion Criteria:
- Individuals with a history of neurological or orthopedic disorders
- Individuals taking medications that may affect ESWT response
- Individuals with local skin conditions, including ulcers or open wounds
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: experimental 1 group
Radial Extracorporeal Shock Wave Therapy and Stretching
|
Participants will sit on a chair and receive rESWT with gel applied to the upper trapezius. A 20 mm rESWT applicator angled at 90° will be applied to the muscle belly and the musculotendinous junction. The intensity will be set at 1.0 bar pressure, 10 Hz frequency, with 1000 shocks. When rESWT is applied to the upper trapezius, participants will sit on a chair and repeatedly bend the neck diagonally to stretch the muscle, then return to the neutral position. |
|
Comparador activo: experimental 2 group
Radial Extracorporeal Shock Wave Therapy and Isometric Contraction
|
Participants will sit on a chair and receive rESWT with gel applied to the upper trapezius. A 20 mm rESWT applicator angled at 90° will be applied to the muscle belly and the musculotendinous junction. The intensity will be set at 1.0 bar pressure, 10 Hz frequency, with 1000 shocks. When rESWT is applied to the upper trapezius, participants will sit on a chair and maintain a shoulder elevation posture during the intervention. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Muscle Tone
Periodo de tiempo: Post-intervention measurement is conducted immediately after the intervention to assess immediate effects.
|
Upper trapezius muscle stiffness will be assessed as dynamic stiffness (N/m) using the MyotonPRO device (Myoton AS, Tallinn, Estonia).
The probe will be positioned perpendicular to the skin over the belly of the upper trapezius muscle.
After a pre-load of approximately 0.18 N, 10 mechanical impulses of approximately 0.4 N at 1 Hz will be delivered.
Measurements will be repeated 3 times, and the mean value will be used for analysis.
Change from baseline will be calculated as the immediate post-intervention value minus the baseline value.
|
Post-intervention measurement is conducted immediately after the intervention to assess immediate effects.
|
|
Muscle Stiffnes
Periodo de tiempo: Post-intervention measurement is conducted immediately after the intervention to assess immediate effects.
|
Upper trapezius muscle stiffness will be assessed as dynamic stiffness (N/m) using the MyotonPRO device (Myoton AS, Tallinn, Estonia).
The probe will be positioned perpendicular to the skin over the belly of the upper trapezius muscle.
After a pre-load of approximately 0.18 N, 10 mechanical impulses of approximately 0.4 N at 1 Hz will be delivered.
Measurements will be repeated 3 times, and the mean value will be used for analysis.
Change from baseline will be calculated as the immediate post-intervention value minus the baseline value.
|
Post-intervention measurement is conducted immediately after the intervention to assess immediate effects.
|
|
Muscle Thickness
Periodo de tiempo: Post-intervention measurement is conducted immediately after the intervention to assess immediate effects.
|
The probe of the ultrasound imaging device is placed perpendicular to the target area without applying any pressure after applying a water-based transmission gel, in order to measure muscle thickness.
Then, using a 2.5 MHz ultrasound, strong echoes at tissue interfaces are focused, and the distance between the focused points is converted into millimeters to determine tissue thickness.
|
Post-intervention measurement is conducted immediately after the intervention to assess immediate effects.
|
|
Grip Strength
Periodo de tiempo: Post-intervention measurement is conducted immediately after the intervention to assess immediate effects.
|
Grip strength is measured using a wireless dynamometer.
The participant holds the dynamometer with the arm relaxed, the elbow flexed at 90°, the arm slightly away from the torso, and the wrist in a neutral position.
Following the researcher's instructions, the participant exerts maximum force.
The measurement is repeated three times, and the average value is recorded.
|
Post-intervention measurement is conducted immediately after the intervention to assess immediate effects.
|
|
Pressure Pain
Periodo de tiempo: Post-intervention measurement is conducted immediately after the intervention to assess immediate effects.
|
The participant sits upright with the back supported by a wall or chair and feet flat on the floor.
A pressure algometer with a 1 cm² rubber tip is placed perpendicular to the same muscle belly measured by the Myoton PRO.
The researcher applies gradual pressure at a constant rate of 0.5 kg/cm²/s until the participant reports pain, and the value at the point of reported pain is recorded.
The measurement is repeated twice, and the average value is used.
|
Post-intervention measurement is conducted immediately after the intervention to assess immediate effects.
|
Colaboradores e Investigadores
Patrocinador
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
- SYU 2025-06-024-001
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.
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. .