NCT07237087

Brief Summary

The purpose of this study is to evaluate the changes in the stiffness of the masseter muscle (a jaw muscle) before and after two types of treatment: applying commercial heat pads or using a commercial massage gun. We will measure the muscle stiffness on the surface of the muscle using a special ultrasound probe, with a method called shear wave elastography. When this muscle is too stiff, it's often linked to jaw pain and problems with the jaw joint - a condition known as Temporomandibular Disorder (TMD). The goal is to find better treatment options for people with TMD and to collect data using this imaging technique.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

November 14, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

November 15, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 19, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

5 months

First QC Date

November 14, 2025

Last Update Submit

November 14, 2025

Conditions

Keywords

TMDshear wave elastographyultrasoundelastographyElasticity Imaging Techniquesheat padmassage gunheat treatmentpercussion massage

Outcome Measures

Primary Outcomes (1)

  • Masseter muscle stiffness

    Muscle stiffness will be assessed using shear wave elastography (SWE) via ultrasound. Results will be reported in kilopascals (kPa) and/or meters per second (m/s).

    The time from the first appointment to the second (final) appointment will be two weeks.

Secondary Outcomes (4)

  • Algometry of the Masseter Muscle

    The time from the first appointment to the second (final) appointment will be two weeks.

  • mouth opening

    The time from the first appointment to the second (final) appointment will be two weeks.

  • maximum bite force

    The time from the first appointment to the second (final) appointment will be two weeks.

  • chewing efficiency

    The time from the first appointment to the second (final) appointment will be two weeks.

Study Arms (2)

Group A: First massage gun, then heat treatment

EXPERIMENTAL

The massage gun is the new treatment (experimental). Heat treatment is already commonly used for muscle stiffness and could be considered an active comparator. However, since its specific effects on the masseter muscle are not well established, it may also be classified as experimental.

Device: massage gunDevice: heat treatment

Group B: first heat treatment, then massage gun

EXPERIMENTAL

The massage gun is the new treatment (experimental). Heat treatment is already commonly used for muscle stiffness and could be considered an active comparator. However, since its specific effects on the masseter muscle are not well established, it may also be classified as experimental.

Device: massage gunDevice: heat treatment

Interventions

The massage gun used in this study will be equipped with a soft attachment designed for use on the face, ensuring safe and comfortable application to the masseter muscle.

Group A: First massage gun, then heat treatmentGroup B: first heat treatment, then massage gun

The heat treatment will be applied for 20min.

Also known as: heat pad, heating pad
Group A: First massage gun, then heat treatmentGroup B: first heat treatment, then massage gun

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Willingness to participate to the study
  • Signed written informed consent

You may not qualify if:

  • Inability to follow procedures or insufficient knowledge of project language, inability to give consent
  • a history of drug ingestion within the past week (e.g. pain relievers, muscle relaxants, botox and anti-inflammatory drugs)
  • systemic diseases
  • Contraindications listed on the massage-gun instruction manual systemic and related to the use on the masseter area.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zentrum für Zahnmedizin

Zurich, Canton of Zurich, 8032, Switzerland

RECRUITING

MeSH Terms

Conditions

Fever

Interventions

Diathermy

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hyperthermia, InducedTherapeutics

Study Officials

  • Mutlu Özcan, Prof. Dr. med. dent.

    University of Zurich

    STUDY CHAIR

Central Study Contacts

Vera Colombo, PD Dr. sc. ETH

CONTACT

Nenad Lukic, Dr. med. Dr. med. dent.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2025

First Posted

November 19, 2025

Study Start

November 15, 2025

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

November 19, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

Upon reasonable request from another research group, the raw IPD will be anonymized and shared.

Time Frame
starting 6 months after publication

Locations