- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Poznan, Polen, 61-871
- Rekruttering
- Poznań University of Physical Education
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Kontakt:
- Dawid Łochyński, PhD, Assoc. Prof.
- Telefonnummer: (61) 835 54 49
- E-mail: lochynski@awf.poznan.pl
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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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Eksperimentel: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Pain intensity (VAS)
Tidsramme: 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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Visual Analog Scale (VAS) for neck pain intensity (0-10 cm scale, where 0=no pain, 10=worst imaginable pain).
Patient marks pain level on 10 cm horizontal line.
Measured supine with head stabilized.
Same researcher throughout.
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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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Neck Disability Index (NDI)
Tidsramme: 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 (0-50 points, higher scores indicate greater disability
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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
Tidsramme: 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 (kPa) of upper trapezius at midpoint (foramen magnum-acromion line).
Measurements performed supine with head stabilized, arms alongside body, cervical spine neutral.
Probe placed at midpoint trapezius.
Ultrasound gel applied for optimal contact.
Each parameter measured 3 times (mean used); repeated if discrepancies.
Same researcher throughout.
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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
Tidsramme: 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 and viscoelastic properties (frequency [Hz], stiffness [N/m], decrement) of upper trapezius at 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 midpoint trapezius.
Same researcher throughout.
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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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Easy angle measurement
Tidsramme: 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, extension, lateral flexion) was measured using EasyAngle goniometer mounted on the patient's head with elastic band.
The patient was seated upright with feet flat on floor, head in neutral position (gaze straight ahead).
Each movement was performed 3 times from neutral (goniometer recalibrated to 0° between trials) and mean value recorded.
All measurements performed by same researcher.
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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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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Doppler ultrasound of transverse cervical artery
Tidsramme: 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 transverse cervical artery just above brachial plexus.
Measurements performed supine with head stabilized, arms alongside body, cervical spine neutral.
Probe positioned over transverse cervical artery.
Ultrasound gel applied for optimal contact.
Each parameter measured 3 times (mean used); repeated if discrepancies.
Same researcher throughout.
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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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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 667/21
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
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