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.
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Typ studie
Typ studie
Zápis (Odhadovaný)
Zápis
Fáze
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
-
Poznan, Polsko, 61-871
- Nábor
- Poznań University of Physical Education
-
Kontakt:
- Dawid Łochyński, PhD, Assoc. Prof.
- Telefonní číslo: (61) 835 54 49
- E-mail: lochynski@awf.poznan.pl
-
-
Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Singl
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
|---|---|
|
Experimentální: 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.
|
Theragun device applied to dominant side of upper trapezius muscle.
Session duration: 3 minutes.
|
|
Experimentální: Longitudinal Stripping Massage Arm
Subjects receiving manual longitudinal stripping massage.
Longitudinal stripping massage of dominant side of upper trapezius muscle.
Session duration: 3 minutes.
|
Longitudinal stripping massage of dominant side of upper trapezius muscle.
Session duration: 3 minutes.
|
Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Neck pain intensity on Visual Analog Scale (VAS)
Časové okno: 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)
|
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
|
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)
|
Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Neck pain-related disability on Neck Disability Index (NDI)
Časové okno: Baseline, 2 days post-therapy (follow-up), immediately before next therapy session, and 2 days post-second therapy (final follow-up)
|
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
|
Baseline, 2 days post-therapy (follow-up), immediately before next therapy session, and 2 days post-second therapy (final follow-up)
|
|
Shear-wave elastography of upper trapezius muscle: mean stiffness
Časové okno: 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)
|
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)
|
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)
|
|
Myotonometry of upper trapezius muscle: oscillation frequency
Časové okno: 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)
|
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)
|
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)
|
|
Myotonometry of upper trapezius muscle: dynamic stiffness
Časové okno: 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)
|
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)
|
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)
|
|
Myotonometry of upper trapezius muscle: decrement
Časové okno: 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)
|
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
|
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)
|
|
Active cervical range of motion: flexion
Časové okno: 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)
|
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
|
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)
|
|
Active cervical range of motion: extension
Časové okno: 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)
|
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)
|
|
Active cervical range of motion: right lateral flexion
Časové okno: 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)
|
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
|
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)
|
|
Active cervical range of motion: left lateral flexion
Časové okno: 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)
|
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
|
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)
|
|
Active cervical range of motion: right rotation
Časové okno: 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)
|
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
|
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)
|
|
Active cervical range of motion: left rotation
Časové okno: 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)
|
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
|
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)
|
Další výstupní opatření
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Peak systolic velocity (Vs) of the transverse cervical artery.
Časové okno: 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)
|
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)
|
|
End-diastolic velocity (Vd) of the transverse cervical artery.
Časové okno: 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)
|
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)
|
|
Resistive index (RI) of the transverse cervical artery.
Časové okno: 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)
|
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)
|
Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Začátek studia
Primární dokončení (Odhadovaný)
Primární dokončení
Dokončení studie (Odhadovaný)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
Další identifikační čísla studie
- 667/21
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .