Effect of Extracorporeal Shock Wave Therapy on Trapezius Muscle Stiffness

NCT ID: NCT06934668

Last Updated: 2025-04-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-24
• Study Completion Date: 2025-06-10

Brief 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. 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.

Conditions

Muscle Stiffness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Extracorporeal Shock Wave Therapy

Intervention Type: DEVICE

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Extracorporeal Shock Wave Therapy

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.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Primorska

OTHER

Sponsor Role: lead

Responsible Party

Žiga Kozinc

PhD, Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kozinc, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Primorska, Faculty of Health Sciences

Locations

University of Primorska, Faculty of Health Sciences, Izola

Izola, Izola, Slovenia

Site Status: RECRUITING

Countries

Slovenia

Central Contacts

Žiga Kozinc, PhD

Role: CONTACT

ziga.kozinc@fvz.upr.si

+38640161503

Facility Contacts

Žiga Kozinc, PhD

Role: primary

ziga.kozinc@fvz.upr.si

040161503

Other Identifiers

ESWT_Trapezius

Identifier Type: -

Identifier Source: org_study_id