- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Poznan, Polska, 61-871
- Rekrutacyjny
- Poznań University of Physical Education
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Kontakt:
- Dawid Łochyński, PhD, Assoc. Prof.
- Numer telefonu: (61) 835 54 49
- E-mail: lochynski@awf.poznan.pl
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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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Eksperymentalny: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Neck pain intensity on Visual Analog Scale (VAS)
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Neck pain-related disability on Neck Disability Index (NDI)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Peak systolic velocity (Vs) of the transverse cervical artery.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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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Współpracownicy i badacze
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 667/21
Plan dla danych uczestnika indywidualnego (IPD)
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Opis planu IPD
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