- 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
-
-
-
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.
|
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 |
|---|---|---|
|
Neck pain intensity on Visual Analog Scale (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)
|
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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neck pain-related disability on 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 (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
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 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
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 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
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 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
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 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
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) 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
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 (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
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 (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
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 (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
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 (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
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 (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)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Peak systolic velocity (Vs) of the 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 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.
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 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.
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 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)
|
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
Keywords
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.
Clinical Trials on Chronic Neck Pain
-
The Hong Kong Polytechnic UniversityNot yet recruitingChronic Neck Pain | Neck Pain Treatment | Neck Pain ChronicHong Kong
-
Universitat Internacional de CatalunyaNot yet recruitingChronic Neck Pain | Non-specific Neck PainSpain
-
Hacettepe UniversityNot yet recruitingChronic Neck PainTurkey (Türkiye)
-
Menna Allah Ahmed Marei ElnaggarNot yet recruitingChronic Neck Pain With Mobility Deficits | Chronic Neck Pain With Mobility Deficits (> 3 Months)Egypt
-
Massachusetts General HospitalCompletedChronic Low Back Pain | Chronic Neck PainUnited States
-
Hochschule OsnabruckNot yet recruitingNeck Pain | Chronic Neck Pain | Neck Disability | Neck Pain Musculoskeletal | Neck Disease
-
KTO Karatay UniversityRecruitingChronic Neck PainTurkey (Türkiye)
-
Foundation University IslamabadNot yet recruiting
-
Hualien Tzu Chi General HospitalCompleted
-
Amira saad mohamedActive, not recruiting
Clinical Trials on Percussion Therapy
-
Bezmialem Vakif UniversityCompletedNeck Pain MusculoskeletalTurkey (Türkiye)
-
Istanbul Medipol University HospitalCompletedPregnancy Complications | Physiotherapy | Edema LegTurkey
-
Vanderbilt University Medical CenterTerminated
-
Riphah International UniversityCompleted
-
Sehat Medical ComplexCompletedHamstring SprainPakistan
-
Cairo UniversityNot yet recruitingKnee Osteoarthritis
-
Istanbul Medipol University HospitalCompletedMusculoskeletal Diseases or Conditions | Sports Physical TherapyTurkey
-
Karabuk UniversityNot yet recruitingMuscle Fatigue and Muscle Oxygenation
-
Istanbul Medipol University HospitalCompletedStretch | Vibration; DisorderTurkey
-
Riphah International UniversityRecruiting