- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Poznan, Poland, 61-871
- Recruiting
- Poznań University of Physical Education
-
Contact:
- Dawid Łochyński, PhD, Assoc. Prof.
- Phone Number: (61) 835 54 49
- Email: lochynski@awf.poznan.pl
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
|
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.
|
Longitudinal stripping massage of dominant side of upper trapezius muscle.
Session duration: 3 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity (VAS)
Time Frame: 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)
|
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.
|
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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neck Disability Index (NDI)
Time Frame: 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 (0-50 points, higher scores indicate greater disability
|
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
Time Frame: 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 (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.
|
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
Time Frame: 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 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.
|
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)
|
|
Easy angle measurement
Time Frame: 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, 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.
|
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)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Doppler ultrasound of transverse cervical artery
Time Frame: 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 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.
|
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)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 667/21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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