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| Name | Class |
|---|---|
| University Hospital, Zürich | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| massage gun | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Algometry of the Masseter Muscle | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vera Colombo, PD Dr. sc. ETH | Contact | +41 (0)44 634 33 11 | vera.colombo@zzm.uzh.ch | |
| Nenad Lukic, Dr. med. Dr. med. dent. | Contact | nenad.lukic@zzm.uzh.ch |
| Name | Affiliation | Role |
|---|---|---|
| Mutlu Özcan, Prof. Dr. med. dent. | University of Zurich | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zentrum für Zahnmedizin | Recruiting | Zurich | Canton of Zurich | 8032 | Switzerland |
Upon reasonable request from another research group, the raw IPD will be anonymized and shared.
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starting 6 months after publication
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| ID | Term |
|---|---|
| D005334 | Fever |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003972 | Diathermy |
| ID | Term |
|---|---|
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
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| heat treatment | Device | The heat treatment will be applied for 20min. |
|
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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 | 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 | 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. |