Healthy ParticipantsNCT07237087
Masseter Muscle Stiffness After Heat Application and Percussion Therapy
A study testing massage gun and heat treatment in people with Healthy Participants, run by University of Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- massage gun and heat treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Nov 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willingness to participate to the study
- Signed written informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nenad Lukic, Dr. med. Dr. med. dent. contact
Switzerland1 site, 1 recruiting
- Recruiting
Zentrum für Zahnmedizin
Zurich, Canton of Zurich, 8032
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Participants
- Being tested
- massage gun, heat treatment
- Keywords
- TMD, shear wave elastography, ultrasound, elastography, Elasticity Imaging Techniques, heat pad, massage gun, heat treatment, percussion massage
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
massage gunDevice
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.
heat treatmentDevice
Also called heat pad, heating pad
The heat treatment will be applied for 20min.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: massage gun; Device: 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. Receives: Device: massage gun; Device: heat treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: The time from the first appointment to the second (final) appointment will be two weeks.
Secondary outcomes (4)
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.
Measured: The time from the first appointment to the second (final) appointment will be two weeks.
mouth opening
The mouth opening will be measured with a ruler.
Measured: 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.
Measured: 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.
Measured: The time from the first appointment to the second (final) appointment will be two weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start15 Nov 2025 (estimated)
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Zürich
- Responsible party
- Sponsor
- Investigators
- Mutlu Özcan, Prof. Dr. med. dent., Study chair, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07237087
- Sponsor's protocol ID
- 2025-00295
- Other IDs
- 2025
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Upon reasonable request from another research group, the raw IPD will be anonymized and shared.
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Heat Application and Percussion Therapy on Masseter Muscle Stiffness Measured With Ultrasound Shear Wave Elastography
- ClinicalTrials.gov ID
- NCT07237087
- Acronym / sponsor ID
- 2025-00295
- Conditions
- Healthy Participants
- Keywords
- TMD, shear wave elastography, ultrasound, elastography, Elasticity Imaging Techniques, heat pad, massage gun, heat treatment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- University Hospital, Zürich
- Study start
- 15 Nov 2025 (estimated)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: First massage gun, then heat treatment | Experimental | Device: massage gun, Device: heat treatmentThe 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 | Device: massage gun, Device: heat treatmentThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Willingness to participate to the study
- Signed written informed consent
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| massage gunThe 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. | Device | Group A: First massage gun, then heat treatment, Group B: first heat treatment, then massage gun |
| heat treatmentAlso: heat pad, heating padThe heat treatment will be applied for 20min. | Device | Group A: First massage gun, then heat treatment, Group B: first heat treatment, then massage gun |
Primary outcome
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).
4 secondary outcomes
Algometry of the Masseter Muscle
Time frame: 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.
maximum bite force
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: Yes. Upon reasonable request from another research group, the raw IPD will be anonymized and shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nenad Lukic, Dr. med. Dr. med. dent. contact
Mutlu Özcan, Prof. Dr. med. dent. study chair
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing massage gun and heat treatment in people with Healthy Participants, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vera Colombo, PD Dr. sc. ETH (+41 (0)44 634 33 11, vera.colombo@zzm.uzh.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Masseter muscle stiffness (time frame: The time from the first appointment to the second (final) appointment will be two weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.