Masseter Muscle Stiffness After Heat Application and Percussion Therapy

Официальное название

Effects of Heat Application and Percussion Therapy on Masseter Muscle Stiffness Measured With Ultrasound Shear Wave Elastography

Обзор

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.

Подробное описание

In our study, participants will be randomly assigned to one of two groups. This is important to ensure reliable results and is called randomization.

The two groups are as follows:

Group A:

First, the stiffness of the masseter muscle in the cheek is measured using ultrasound. Then, we will assess the mouth opening, the muscle's sensitivity to pressure, bite force, and chewing efficiency using several short tests. After that, the masseter muscle will be treated with a massage gun with a soft attachment for 2 minutes. All tests will be repeated after the treatment.

Group B:

First, the stiffness of the masseter muscle in the cheek is measured using ultrasound. Then, we will assess the mouth opening, the muscle's sensitivity to pressure, bite force, and chewing efficiency using several short tests. After that, the masseter muscle will be treated with a heat pad for 20 minutes. The heat pad will be held in place with a strap, and participants may sit and read or relax during the treatment. All tests will be repeated after the treatment.

Each participant will receive both treatments (massage gun and heat pad), but in a different order depending on group assignment. There will be a two-week washout phase between the two treatments to ensure that the effects of the first treatment do not influence the second.

Вмешательства

• Устройство massage gun
  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.
• Устройство heat treatment
  The heat treatment will be applied for 20min.

Первичные конечные точки

• Masseter muscle stiffness [Срок оценки: The time from the first appointment to the second (final) appointment will be two weeks.]

Вторичные конечные точки (4)

• Algometry of the Masseter Muscle [Срок оценки: The time from the first appointment to the second (final) appointment will be two weeks.]
• mouth opening [Срок оценки: The time from the first appointment to the second (final) appointment will be two weeks.]
• maximum bite force [Срок оценки: The time from the first appointment to the second (final) appointment will be two weeks.]
• chewing efficiency [Срок оценки: The time from the first appointment to the second (final) appointment will be two weeks.]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швейцария · 1 центр

• Zentrum für Zahnmedizin — Zurich

Идентификаторы

NCT: NCT07237087 · 2025-00295

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗