- ICH GCP
- Registr klinických studií v USA
- Klinická studie 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.
Přehled studie
Postavení
Podmínky
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Gwangju, Jižní Korea, 62287
- 73, Bungmun-daero 419beon-gil, Gwangju health university
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Aktivní komparátor: experimental 1 group
Radial Extracorporeal Shock Wave Therapy and Stretching
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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. |
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Aktivní komparátor: experimental 2 group
Radial Extracorporeal Shock Wave Therapy and Isometric Contraction
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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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Muscle Tone
Časové okno: Post-intervention measurement is conducted immediately after the intervention to assess immediate effects.
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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.
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Post-intervention measurement is conducted immediately after the intervention to assess immediate effects.
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Muscle Stiffnes
Časové okno: Post-intervention measurement is conducted immediately after the intervention to assess immediate effects.
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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.
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Post-intervention measurement is conducted immediately after the intervention to assess immediate effects.
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Muscle Thickness
Časové okno: Post-intervention measurement is conducted immediately after the intervention to assess immediate effects.
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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.
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Post-intervention measurement is conducted immediately after the intervention to assess immediate effects.
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Grip Strength
Časové okno: Post-intervention measurement is conducted immediately after the intervention to assess immediate effects.
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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.
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Post-intervention measurement is conducted immediately after the intervention to assess immediate effects.
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Pressure Pain
Časové okno: Post-intervention measurement is conducted immediately after the intervention to assess immediate effects.
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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.
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Post-intervention measurement is conducted immediately after the intervention to assess immediate effects.
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
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