- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07237087
Masseter Muscle Stiffness After Heat Application and Percussion Therapy
Effects of Heat Application and Percussion Therapy on Masseter Muscle Stiffness Measured With Ultrasound Shear Wave Elastography
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Vera Colombo, PD Dr. sc. ETH
- Phone Number: +41 (0)44 634 33 11
- Email: vera.colombo@zzm.uzh.ch
Study Contact Backup
- Name: Nenad Lukic, Dr. med. Dr. med. dent.
- Email: nenad.lukic@zzm.uzh.ch
Study Locations
-
-
Canton of Zurich
-
Zurich, Canton of Zurich, Switzerland, 8032
- Recruiting
- Zentrum für Zahnmedizin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Willingness to participate to the study
- Signed written informed consent
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A: First massage gun, then heat treatment
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.
|
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.
The heat treatment will be applied for 20min.
Other Names:
|
|
Experimental: Group B: first heat treatment, then massage gun
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.
|
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.
The heat treatment will be applied for 20min.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Masseter muscle stiffness
Time Frame: The time from the first appointment to the second (final) appointment will be two weeks.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Algometry of the Masseter Muscle
Time Frame: The time from the first appointment to the second (final) appointment will be two weeks.
|
Algometry is the quantitative assessment of pain sensitivity, performed using a pressure algometer to determine pressure pain thresholds (PPTs) at specific anatomical sites.
|
The time from the first appointment to the second (final) appointment will be two weeks.
|
|
mouth opening
Time Frame: The time from the first appointment to the second (final) appointment will be two weeks.
|
The mouth opening will be measured with a ruler.
|
The time from the first appointment to the second (final) appointment will be two weeks.
|
|
maximum bite force
Time Frame: The time from the first appointment to the second (final) appointment will be two weeks.
|
Maximum bite force can be measured with a bite sensor or an occlusal force-meter, that is placed between the patients' teeth.
The patient is requested to bite on the bite sensor as hard as possible.
Bite force is usually measured in Newton.
|
The time from the first appointment to the second (final) appointment will be two weeks.
|
|
chewing efficiency
Time Frame: The time from the first appointment to the second (final) appointment will be two weeks.
|
Chewing efficiency will be measured with a two-coloured chewing gum.
The person tested will take two chewing gums simultaneously, both with different colour.
The gums must be chewed 20 times and after that the mass is pressed on a glass plate and is analysed how much the colours have mixed.
|
The time from the first appointment to the second (final) appointment will be two weeks.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Mutlu Özcan, Prof. Dr. med. dent., University of Zurich
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025-00295
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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