Muscle StiffnessESWT-TrapeziusNCT06934668
Effect of Extracorporeal Shock Wave Therapy on Trapezius Muscle Stiffness
A study testing Extracorporeal Shock Wave Therapy in people with Muscle Stiffness, run by University of Primorska at 1 site in Slovenia.
Trial summary
This study will examine whether extracorporeal shock wave therapy (ESWT) can reduce stiffness in the upper trapezius muscle. Muscle stiffness will be measured using a special ultrasound technique called shear-wave elastography (SWE), which allows researchers to assess changes in muscle properties. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Stiffness
- What is being tested?
- Extracorporeal Shock Wave Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSlovenia
- Study dates
- 24 Apr 2025to 10 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
University of Primorska, Faculty of Health Sciences, Izola
Izola, Municipality of Izola, 6310
About this study
Official title: Effect of Extracorporeal Shock Wave Therapy on Trapezius Muscle Stiffness Assessed Using Shear-Wave Elastography
This study will examine whether extracorporeal shock wave therapy (ESWT) can reduce stiffness in the upper trapezius muscle. Muscle stiffness will be measured using a special ultrasound technique called shear-wave elastography (SWE), which allows researchers to assess changes in muscle properties. The aim of the study is to better understand if ESWT is effective in improving muscle function and reducing discomfort in this region. Healthy volunteers will be enrolled, and measurements will be taken before and after the ESWT treatment.
Read the 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.
- Conditions
- Muscle Stiffness
- Being tested
- Extracorporeal Shock Wave Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Shock Wave TherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| ESWT | Experimental | 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). Receives: Device: Extracorporeal Shock Wave Therapy |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trapezius Muscle Stiffness
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.
Measured: Baseline and Immediately Post-Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start24 Apr 2025
- Primary completion25 May 2025
- Study completion10 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle StiffnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either an ESWT intervention group or a control group for comparison of changes in muscle stiffness.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Primorska
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Žiga Kozinc, University of Primorska
- Investigators
- Kozinc, PhD, Principal investigator, University of Primorska, Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06934668
- Sponsor's protocol ID
- ESWT_Trapezius
- Acronym
- ESWT-Trapezius
- Status last verified
- Mar 2026
- First submitted
- 11 Apr 2025
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Extracorporeal Shock Wave Therapy on Trapezius Muscle Stiffness Assessed Using Shear-Wave Elastography
- ClinicalTrials.gov ID
- NCT06934668
- Acronym / sponsor ID
- ESWT-Trapezius / ESWT_Trapezius
- Conditions
- Muscle Stiffness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of PrimorskaUniversity, hospital or other
- Study start
- 24 Apr 2025 (actual)
- Primary completion
- 25 May 2025 (actual)
- Study completion
- 10 Jun 2025 (actual)
- First posted
- 18 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will examine whether extracorporeal shock wave therapy (ESWT) can reduce stiffness in the upper trapezius muscle. Muscle stiffness will be measured using a special ultrasound technique called shear-wave elastography (SWE), which allows researchers to assess changes in muscle properties. The aim of the study is to better understand if ESWT is effective in improving muscle function and reducing discomfort in this region. Healthy volunteers will be enrolled, and measurements will be taken before and after the ESWT 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either an ESWT intervention group or a control group for comparison of changes in muscle stiffness.
| Arm | Type | Receives |
|---|---|---|
| ESWT | Experimental | Device: Extracorporeal Shock Wave TherapyParticipants in this arm will receive a single session of extracorporeal shock wave therapy (ESWT) applied to the upper trapezius muscle (2300 waves in total). |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Extracorporeal Shock Wave TherapyA 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. | Device | ESWT |
Primary outcome
Trapezius Muscle Stiffness
Time frame: Baseline and Immediately Post-Intervention
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kozinc, PhD principal investigator
University of Primorska, Faculty of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal Shock Wave Therapy in people with Muscle Stiffness, run by University of Primorska at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trapezius Muscle Stiffness (time frame: Baseline and Immediately Post-Intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.