- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06934668
Effect of Extracorporeal Shock Wave Therapy on Trapezius Muscle Stiffness (ESWT-Trapezius)
Effect of Extracorporeal Shock Wave Therapy on Trapezius Muscle Stiffness Assessed Using Shear-Wave Elastography
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This interventional study investigates the acute effects of extracorporeal shock wave therapy (ESWT) on the mechanical properties of the upper trapezius muscle, with a specific focus on muscle stiffness. Stiffness will be quantified using shear-wave elastography (SWE), a non-invasive ultrasound-based imaging modality that allows for real-time assessment of tissue elasticity.
Participants will undergo baseline SWE measurements of the upper trapezius muscle, followed by the application of a standardized ESWT protocol. Post-treatment measurements will be conducted immediately after the intervention to evaluate acute changes in stiffness. The primary objective is to determine whether a single session of ESWT induces measurable changes in muscle mechanical properties.
This study will contribute to the growing body of evidence regarding the physiological effects of ESWT on skeletal muscle tissue and its potential application in clinical and sports settings. Data collected will also support the development of future longitudinal studies assessing the therapeutic relevance of ESWT for myofascial dysfunction and musculoskeletal pain syndromes.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Municipality of Izola
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Izola, Municipality of Izola, Slovenia, 6310
- University of Primorska, Faculty of Health Sciences, Izola
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 18 and 45 years
- Healthy individuals with no current musculoskeletal or neurological disorders
- No history of neck or shoulder surgery
- Willingness to abstain from vigorous upper-body exercise 24 hours prior to -measurements
Exclusion Criteria:
- Presence of neck or shoulder pain within the past 3 months
- Diagnosed myofascial pain syndrome or fibromyalgia
- History of cervical spine injury or neurological conditions affecting upper limbs
- Use of analgesic or muscle relaxant medication within 48 hours prior to testing
- Pregnancy
- Contraindications to ESWT (e.g., bleeding disorders, pacemaker, malignancy in treatment area)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: ESWT
Participants in this arm will receive a single session of extracorporeal shock wave therapy (ESWT) applied to the upper trapezius muscle (2300 waves in total).
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A single session of focused extracorporeal shock wave therapy (ESWT) applied to the upper trapezius muscle (2300 shocks).
The treatment is applied to the muscle belly region with coupling gel, without local anesthesia.
The protocol is designed to assess the acute effects of ESWT on muscle stiffness measured using shear-wave elastography.
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No Intervention: Control group
Participants in this arm will not receive any therapeutic intervention.
Muscle stiffness of the upper trapezius will be measured at the same time points as in the experimental group using shear-wave elastography, to evaluate the natural variability in stiffness and to serve as a comparison for the effects of ESWT.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Trapezius Muscle Stiffness
Time Frame: Baseline and Immediately Post-Intervention
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Muscle stiffness of the upper trapezius will be measured using shear-wave elastography (SWE).
The measure represents the shear modulus (in kilopascals) of the muscle tissue, as quantified by ultrasound imaging.
Measurements will be taken with the participant in a standardized seated position, with minimal muscle activity.
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Baseline and Immediately Post-Intervention
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kozinc, PhD, University of Primorska, Faculty of Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- ESWT_Trapezius
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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