NCT06934668

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 18, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

April 24, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2025

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2025

Completed
Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

1 month

First QC Date

April 11, 2025

Last Update Submit

March 31, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and Immediately Post-Intervention

Study Arms (2)

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).

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.

Interventions

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.

ESWT

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Primorska, Faculty of Health Sciences, Izola

Izola, Municipality of Izola, 6310, Slovenia

Location

MeSH Terms

Interventions

Extracorporeal Shockwave Therapy

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Kozinc, PhD

    University of Primorska, Faculty of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to either an ESWT intervention group or a control group for comparison of changes in muscle stiffness.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, Assistant professor

Study Record Dates

First Submitted

April 11, 2025

First Posted

April 18, 2025

Study Start

April 24, 2025

Primary Completion

May 25, 2025

Study Completion

June 10, 2025

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations