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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07630142
Longitudinal Stripping Massage vs. Percussion Device for Neck Pain: Ultrasound Study.
The Effect of Percussion Therapy on Neck Functional Disability, Pain and Upper Trapezius Muscle Properties Assessed by Elastography and Doppler Ultrasound in Patients With Neck Pain.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Poznan, Polonia, 61-871
- Reclutamiento
- Poznan University of Physical Education
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Contacto:
- Dawid Łochyński, PhD, Assoc. Prof.
- Número de teléfono: (61) 835 54 49
- Correo electrónico: lochynski@awf.poznan.pl
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age: 18-60 years
- Neck pain persisting for at least 3 months
- Visual Analog Scale (VAS) score between 3 and 7
- Neck Disability Index (NDI) between 30% and 48%
Exclusion Criteria:
- Pregnancy and postpartum period
- History of cervical spine or shoulder surgery
- Diagnosed fibromyalgia, radiculopathy, or myelopathy
- Myofascial therapy within the last 3 months
- Use of analgesic medication within 48 hours before assessment
- Venous diseases
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Percussion Therapy Arm
Subjects receiving percussion therapy using a massage device.
Theragun device applied to dominant side of upper trapezius muscle.
Session duration: 3 minutes.
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Theragun device applied to dominant side of upper trapezius muscle.
Session duration: 3 minutes.
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Experimental: Longitudinal Stripping Massage Arm
Subjects receiving manual longitudinal stripping massage.
Longitudinal stripping massage of dominant side of upper trapezius muscle.
Session duration: 3 minutes.
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Longitudinal stripping massage of dominant side of upper trapezius muscle.
Session duration: 3 minutes.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Neck pain intensity on Visual Analog Scale (VAS)
Periodo de tiempo: Baseline, 20 minutes post-therapy, 2 days post-therapy (follow-up), immediately before next therapy session, 20 minutes post-second therapy, and 2 days post-second therapy (final follow-up)
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Neck pain intensity evaluated using a Visual Analog Scale slide scale (score range 0-10, where 0 = no pain and 10 = worst imaginable pain).
The patient marks their pain level using the slider, and the result is recorded as a numerical score.
Unit of Measure: points
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Baseline, 20 minutes post-therapy, 2 days post-therapy (follow-up), immediately before next therapy session, 20 minutes post-second therapy, and 2 days post-second therapy (final follow-up)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Neck pain-related disability on Neck Disability Index (NDI)
Periodo de tiempo: Baseline, 2 days post-therapy (follow-up), immediately before next therapy session, and 2 days post-second therapy (final follow-up)
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Neck pain-related disability measured with the Neck Disability Index (score range 0-50 points, where higher scores indicate greater disability).
Unit of Measure: points
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Baseline, 2 days post-therapy (follow-up), immediately before next therapy session, and 2 days post-second therapy (final follow-up)
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Shear-wave elastography of upper trapezius muscle: mean stiffness
Periodo de tiempo: Baseline, 20 minutes post-therapy, 2 days post-therapy (follow-up), immediately before next therapy session, 20 minutes post-second therapy, and 2 days post-second therapy (final follow-up)
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Ultrasound shear-wave elastography of the upper trapezius muscle at the midpoint (foramen magnum-acromion line) to evaluate the mean stiffness value.
Measurements performed supine with head stabilized, arms alongside body, cervical spine neutral.
Probe placed at the midpoint of the trapezius.
Ultrasound gel applied for optimal contact.
The measurement is performed 3 times and the average value is used; repeated if discrepancies.
Same researcher throughout.
Unit of Measure: kilopascals (kPa)
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Baseline, 20 minutes post-therapy, 2 days post-therapy (follow-up), immediately before next therapy session, 20 minutes post-second therapy, and 2 days post-second therapy (final follow-up)
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Myotonometry of upper trapezius muscle: oscillation frequency
Periodo de tiempo: Baseline, 20 minutes post-therapy, 2 days post-therapy (follow-up), immediately before next therapy session, 20 minutes post-second therapy, and 2 days post-second therapy (final follow-up)
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Assessment of myofascial tissue tone (oscillation frequency) of the upper trapezius at the midpoint (foramen magnum-acromion line) using MyotonPRO device.
Measurements performed supine with head stabilized, arms alongside body, cervical spine neutral.
Probe placed perpendicular to the muscle surface at the midpoint of the trapezius.
Same researcher throughout.
Unit of Measure: hertz (Hz)
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Baseline, 20 minutes post-therapy, 2 days post-therapy (follow-up), immediately before next therapy session, 20 minutes post-second therapy, and 2 days post-second therapy (final follow-up)
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Myotonometry of upper trapezius muscle: dynamic stiffness
Periodo de tiempo: Baseline, 20 minutes post-therapy, 2 days post-therapy (follow-up), immediately before next therapy session, 20 minutes post-second therapy, and 2 days post-second therapy (final follow-up)
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Assessment of biomechanical properties (dynamic stiffness) of the upper trapezius at the midpoint (foramen magnum-acromion line) using MyotonPRO device.
Measurements performed supine with head stabilized, arms alongside body, cervical spine neutral.
Probe placed perpendicular to the muscle surface at the midpoint of the trapezius.
Same researcher throughout.
Unit of Measure: newtons per meter (N/m)
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Baseline, 20 minutes post-therapy, 2 days post-therapy (follow-up), immediately before next therapy session, 20 minutes post-second therapy, and 2 days post-second therapy (final follow-up)
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Myotonometry of upper trapezius muscle: decrement
Periodo de tiempo: Baseline, 20 minutes post-therapy, 2 days post-therapy (follow-up), immediately before next therapy session, 20 minutes post-second therapy, and 2 days post-second therapy (final follow-up)
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Assessment of viscoelastic properties (logarithmic decrement of oscillation, reflecting elasticity) of the upper trapezius at the midpoint (foramen magnum-acromion line) using MyotonPRO device.
Measurements performed supine with head stabilized, arms alongside body, cervical spine neutral.
Probe placed perpendicular to the muscle surface at the midpoint of the trapezius.
Same researcher throughout.
Unit of Measure: dimensionless
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Baseline, 20 minutes post-therapy, 2 days post-therapy (follow-up), immediately before next therapy session, 20 minutes post-second therapy, and 2 days post-second therapy (final follow-up)
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Active cervical range of motion: flexion
Periodo de tiempo: Baseline, 20 minutes post-therapy, 2 days post-therapy (follow-up), immediately before next therapy session, 20 minutes post-second therapy, and 2 days post-second therapy (final follow-up)
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Active cervical range of motion (flexion) measured using EasyAngle goniometer mounted on the patient's head with an elastic band.
The patient is seated upright with feet flat on the floor, head in neutral position.
The movement is performed 3 times from neutral (goniometer recalibrated to 0° between trials) and the mean value is recorded.
All measurements performed by the same researcher.
Unit of Measure: degrees
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Baseline, 20 minutes post-therapy, 2 days post-therapy (follow-up), immediately before next therapy session, 20 minutes post-second therapy, and 2 days post-second therapy (final follow-up)
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Active cervical range of motion: extension
Periodo de tiempo: Baseline, 20 minutes post-therapy, 2 days post-therapy (follow-up), immediately before next therapy session, 20 minutes post-second therapy, and 2 days post-second therapy (final follow-up)
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Active cervical range of motion (extension) measured using EasyAngle goniometer mounted on the patient's head with an elastic band. The patient is seated upright with feet flat on the floor, head in neutral position. The movement is performed 3 times from neutral (goniometer recalibrated to 0° between trials) and the mean value is recorded. All measurements performed by the same researcher. Unit of Measure: degrees |
Baseline, 20 minutes post-therapy, 2 days post-therapy (follow-up), immediately before next therapy session, 20 minutes post-second therapy, and 2 days post-second therapy (final follow-up)
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Active cervical range of motion: right lateral flexion
Periodo de tiempo: Baseline, 20 minutes post-therapy, 2 days post-therapy (follow-up), immediately before next therapy session, 20 minutes post-second therapy, and 2 days post-second therapy (final follow-up)
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Active cervical range of motion (right lateral flexion) measured using EasyAngle goniometer mounted on the patient's head with an elastic band.
The patient is seated upright with feet flat on the floor, head in neutral position.
The movement is performed 3 times from neutral (goniometer recalibrated to 0° between trials) and the mean value is recorded.
All measurements performed by the same researcher.
Unit of Measure: degrees
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Baseline, 20 minutes post-therapy, 2 days post-therapy (follow-up), immediately before next therapy session, 20 minutes post-second therapy, and 2 days post-second therapy (final follow-up)
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Active cervical range of motion: left lateral flexion
Periodo de tiempo: Baseline, 20 minutes post-therapy, 2 days post-therapy (follow-up), immediately before next therapy session, 20 minutes post-second therapy, and 2 days post-second therapy (final follow-up)
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Active cervical range of motion (left lateral flexion) measured using EasyAngle goniometer mounted on the patient's head with an elastic band.
The patient is seated upright with feet flat on the floor, head in neutral position.
The movement is performed 3 times from neutral (goniometer recalibrated to 0° between trials) and the mean value is recorded.
All measurements performed by the same researcher.
Unit of Measure: degrees
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Baseline, 20 minutes post-therapy, 2 days post-therapy (follow-up), immediately before next therapy session, 20 minutes post-second therapy, and 2 days post-second therapy (final follow-up)
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Active cervical range of motion: right rotation
Periodo de tiempo: Baseline, 20 minutes post-therapy, 2 days post-therapy (follow-up), immediately before next therapy session, 20 minutes post-second therapy, and 2 days post-second therapy (final follow-up)
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Active cervical range of motion (right rotation) measured using EasyAngle goniometer mounted on the patient's head with an elastic band.
The patient is seated upright with feet flat on the floor, head in neutral position.
The movement is performed 3 times from neutral (goniometer recalibrated to 0° between trials) and the mean value is recorded.
All measurements performed by the same researcher.
Unit of Measure: degrees
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Baseline, 20 minutes post-therapy, 2 days post-therapy (follow-up), immediately before next therapy session, 20 minutes post-second therapy, and 2 days post-second therapy (final follow-up)
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Active cervical range of motion: left rotation
Periodo de tiempo: Baseline, 20 minutes post-therapy, 2 days post-therapy (follow-up), immediately before next therapy session, 20 minutes post-second therapy, and 2 days post-second therapy (final follow-up)
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Active cervical range of motion (left rotation) measured using EasyAngle goniometer mounted on the patient's head with an elastic band.
The patient is seated upright with feet flat on the floor, head in neutral position.
The movement is performed 3 times from neutral (goniometer recalibrated to 0° between trials) and the mean value is recorded.
All measurements performed by the same researcher.
Unit of Measure: degrees
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Baseline, 20 minutes post-therapy, 2 days post-therapy (follow-up), immediately before next therapy session, 20 minutes post-second therapy, and 2 days post-second therapy (final follow-up)
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Peak systolic velocity (Vs) of the transverse cervical artery.
Periodo de tiempo: Baseline, 20 minutes post-therapy, 2 days post-therapy (follow-up), immediately before next therapy session, 20 minutes post-second therapy, and 2 days post-second therapy (final follow-up)
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Doppler ultrasound of the transverse cervical artery to evaluate Vs. Measurements performed supine with head stabilized, arms alongside body, cervical spine neutral. Probe positioned over the transverse cervical artery. Ultrasound gel applied for optimal contact. The measurement is performed 3 times and the mean value is used; repeated if discrepancies. Same researcher throughout. Unit of Measure: millimeters per second (mm/s) |
Baseline, 20 minutes post-therapy, 2 days post-therapy (follow-up), immediately before next therapy session, 20 minutes post-second therapy, and 2 days post-second therapy (final follow-up)
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End-diastolic velocity (Vd) of the transverse cervical artery.
Periodo de tiempo: Baseline, 20 minutes post-therapy, 2 days post-therapy (follow-up), immediately before next therapy session, 20 minutes post-second therapy, and 2 days post-second therapy (final follow-up)
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Doppler ultrasound of the transverse cervical artery to evaluate Vd. Measurements performed supine with head stabilized, arms alongside body, cervical spine neutral. Probe positioned over the transverse cervical artery. Ultrasound gel applied for optimal contact. The measurement is performed 3 times and the mean value is used; repeated if discrepancies. Same researcher throughout. • Unit of Measure: millimeters per second (mm/s) |
Baseline, 20 minutes post-therapy, 2 days post-therapy (follow-up), immediately before next therapy session, 20 minutes post-second therapy, and 2 days post-second therapy (final follow-up)
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Resistive index (RI) of the transverse cervical artery.
Periodo de tiempo: Baseline, 20 minutes post-therapy, 2 days post-therapy (follow-up), immediately before next therapy session, 20 minutes post-second therapy, and 2 days post-second therapy (final follow-up)
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Doppler ultrasound of the transverse cervical artery to evaluate RI. Measurements performed supine with head stabilized, arms alongside body, cervical spine neutral. Probe positioned over the transverse cervical artery. Ultrasound gel applied for optimal contact. The measurement is performed 3 times and the mean value is used; repeated if discrepancies. Same researcher throughout. • Unit of Measure: dimensionless (lub ratio / score) |
Baseline, 20 minutes post-therapy, 2 days post-therapy (follow-up), immediately before next therapy session, 20 minutes post-second therapy, and 2 days post-second therapy (final follow-up)
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
- 667/21
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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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