BruxismNCT07506733
Effects of Different Graston Technique Application Speeds on Trapezius Muscle Stiffness, Pressure Pain Threshold, Pain, and Muscle Oxygenation in Patients With Bruxism
A study testing Graston Technique 60 BPM and Graston Technique 120 BPM in people with Bruxism, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
This randomized crossover study aims to address an important gap in manual therapy by examining the acute physiological effects of different Graston Technique application speeds (60 BPM vs. 120 BPM) on the dominant upper trapezius muscle in patients with bruxism. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Bruxism
- What is being tested?
- Graston Technique 60 BPM and Graston Technique 120 BPM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Mar 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with bruxism.
- Aged 18-55 years.
- Presence of trigger points in the trapezius muscle, according to the criteria defined by Travell and Simons.
Who cannot join
- Acute tears, tendon ruptures, or severe muscle injuries.
- Conditions that prevent the application of the Graston Technique (e.g., skin lesions, open wounds, infections).
- Having received botox injections in the temporomandibular joint (TMJ) region within the last 6 months.
- Psychological disorders that may affect participation or measurements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study on the Effects of Different Application Speeds of the Graston Technique on Trapezius Muscle Stiffness, Pressure Pain Threshold, Pain Intensity, and Muscle Oxygenation in Individuals With Bruxism
This randomized crossover study aims to address an important gap in manual therapy by examining the acute physiological effects of different Graston Technique application speeds (60 BPM vs. 120 BPM) on the dominant upper trapezius muscle in patients with bruxism. Although the Graston Technique is widely used, the specific impact of application speed on parameters such as muscle stiffness, muscle oxygenation, pressure pain threshold, and pain intensity remains under-investigated. By utilizing a crossover design with a 1-week washout period, this study allows for a precise within-subject comparison of the two speeds. The findings will clarify the optimal application frequency, providing objective data to guide the development of more effective, evidence-based manual therapy protocols for bruxism management.
Read the detailed description
Background and Rationale: Bruxism is a condition characterized by repetitive jaw muscle activity, which frequently leads to secondary musculoskeletal symptoms in the cervical region, particularly increasing muscle stiffness and pain in the upper trapezius muscle. While Instrument-Assisted Soft Tissue Mobilization (IASTM), specifically the Graston Technique, is a widely utilized intervention for managing myofascial restrictions, the optimal application parameters remain unclear. Specifically, the physiological impact of the application speed (frequency) on tissue properties and hemodynamics has not been systematically investigated in this population.
Study Design and Protocol: This study utilizes a prospective, randomized, crossover design to evaluate the acute effects of two different Graston Technique application speeds. A total of 36 participants diagnosed with bruxism will be included. Using a block randomization method, participants will be assigned to one of two intervention sequences (AB or BA) to ensure a balanced distribution.
Intervention Protocol: The study targets the dominant upper trapezius muscle. Each participant will complete two sessions separated by a 1-week washout period to prevent carry-over effects. The interventions are as follows:
Slow Speed Application (60 BPM): The Graston technique will be applied at a frequency of 60 beats per minute (1 Hz).
Fast Speed Application (120 BPM): The Graston technique will be applied at a frequency of 120 beats per minute (2 Hz).
For both conditions, the application speed will be standardized and controlled using a metronome. The duration of the intervention is set to 5 minutes per session. The application pressure will be kept consistent by the same physiotherapist throughout the study.
Outcome Measures: Assessments will be performed immediately before (pre-intervention) and immediately after (post-intervention) each session to measure acute changes. The following parameters will be evaluated:
Muscle Stiffness and Tone: Evaluated objectively using an ultrasound shear wave elastography to assess viscoelastic properties.
Muscle Oxygenation: Hemodynamic changes (tissue oxygenation index) will be monitored using Near-Infrared Spectroscopy (NIRS).
Pressure Pain Threshold (PPT): Assessed using an algometer to quantify mechanical pain sensitivity.
Pain Intensity: Subjective pain levels will be rated by participants using a Visual Analog Scale (VAS).
This study aims to determine whether a specific application speed provides superior physiological benefits, thereby contributing to the development of evidence-based manual therapy protocols for patients with bruxism.
- Conditions
- Bruxism
- Being tested
- Graston Technique 60 BPM, Graston Technique 120 BPM
- Keywords
- Graston technique, muscle stiffness, trapezius, oxygenation, pain, trigger points
- Medical subject headings
- Bruxism, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graston Technique 60 BPMBehavioural
GT1 and GT4 instruments will be applied using different strokes. To prepare the participant's tissue, the clinician will perform a light-intensity sweeping stroke with the GT1 instrument for 1 minute. Next, the tissue around the trigger points will be treated with a fanning stroke using the GT4 instrument for 2 minutes. Finally, the marked trigger points will be treated with a swivel stroke using the button end of the GT1 instrument for 2 minutes.
During the application, the participant will sit upright with their arms resting on their thighs. The instruments will be applied at a 30 to 60-degree angle using multidirectional strokes. The application speed will be controlled using a metronome and performed at 60 beats per minute (BPM).
Graston Technique 120 BPMBehavioural
GT1 and GT4 instruments will be applied using different strokes. To prepare the participant's tissue, the clinician will perform a light-intensity sweeping stroke with the GT1 instrument for 1 minute. Next, the tissue around the trigger points will be treated with a fanning stroke using the GT4 instrument for 2 minutes. Finally, the marked trigger points will be treated with a swivel stroke using the button end of the GT1 instrument for 2 minutes.
During the application, the participant will sit upright with their arms resting on their thighs. The instruments will be applied at a 30 to 60-degree angle using multidirectional strokes. The application speed will be controlled using a metronome and performed at 120 beats per minute (BPM).
| Study group | Role | What they receive |
|---|---|---|
| Sequence A slow then fast | Experimental | Participants assigned to this sequence will receive the Graston Technique application at a slow speed (60 BPM) in the first session. After a mandatory 1-week washout period to prevent carry-over effects, they will cross over to receive the Graston Technique application at a fast speed (120 BPM) in the second session. Receives: Behavioral: Graston Technique 60 BPM |
| Sequence B fast then slow | Experimental | Participants assigned to this sequence will receive the Graston Technique application at a fast speed (120 BPM) in the first session. After a mandatory 1-week washout period to prevent carry-over effects, they will cross over to receive the Graston Technique application at a slow speed (60 BPM) in the second session. Receives: Behavioral: Graston Technique 120 BPM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle stiffness
Shear Wave Elastography (SWE), an ultrasound-based imaging method, will be used to assess muscle stiffness in the participants. Ultrasonography will be performed using a high-resolution LOGIQ P10 device (ML6-15-RS; GE Healthcare Inc., Chicago, IL, USA). During the examination, L3-12 Hd and L8-18i linear probes will be used. To measure upper trapezius muscle stiffness, the ultrasound probe will be placed 2 cm lateral to the midpoint between the acromion of the scapula and the spinous process of the seventh cervical vertebra (C7). Measurements will be taken when several muscle fascicles are visible continuously along the imaging plane. Each measurement will be repeated three times for the assessed muscle, and stiffness parameters will be calculated quantitatively. The average of the three measurements will be recorded in meters per second (m/s).
Measured: Baseline and immediately post-intervention for each treatment session
Muscle oxygenation
Using near-infrared spectroscopy (NIRS) to evaluate trapezius muscle oxygen levels. Measurements will be performed both at rest and during muscle contraction. The measurement area will be shaved if necessary to prevent errors caused by hair. The area will then be cleaned with a cotton pad soaked in 70% alcohol solution. Participants will be seated with their feet flat on the floor, knees and hips flexed at 90°, and arms resting loosely on their thighs. For the upper trapezius muscle, the location of the probe will be determined as the midpoint of the line extending from the acromion to the spinous process of the C7 vertebra.
Measured: Baseline and immediately post-intervention for each treatment session
Secondary outcomes (2)
Pressure pain threshold
Pressure pain threshold (PPT) will be assessed using a digital algometer. The PPT, which measures peak force in Newtons, will be determined using a digital algometer consisting of a padded disc connected to a microprocessor-controlled unit (Lafayette Manual Muscle Test System™, Model 01163, Lafayette Instrument Company, Indiana, USA). The upper trapezius muscle's pressure pain threshold will be evaluated with this device. During the assessment, the researcher will place the algometer on the predetermined trigger points of the muscle, and the participant will verbally indicate when the sensation of pressure turns into pain. The applied pressure at that moment will be read from the digital display.
Measured: Baseline and immediately post-intervention for each treatment session
Pain intensity
Pain intensity will be assessed using the Visual Analog Scale (VAS), a 0-10 scale where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Measured: Baseline and immediately post-intervention for each treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start25 Mar 2025
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BruxismStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be randomized into two sequences using block randomization. Sequence AB: Participants receive the Slow Application (60 BPM) in the first session, followed by a 1-week washout period, and then receive the Fast Application (120 BPM) in the second session. Sequence BA: Participants receive the Fast Application (120 BPM) in the first session, followed by a 1-week washout period, and then receive the Slow Application (60 BPM) in the second session. Interventions are applied to the dominant upper trapezius muscle.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fadime GULCAN, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07506733
- Sponsor's protocol ID
- 2025 - 494
- Status last verified
- Oct 2025
- First submitted
- 24 Mar 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Effects of Different Application Speeds of the Graston Technique on Trapezius Muscle Stiffness, Pressure Pain Threshold, Pain Intensity, and Muscle Oxygenation in Individuals With Bruxism
- ClinicalTrials.gov ID
- NCT07506733
- Acronym / sponsor ID
- 2025 - 494
- Conditions
- Bruxism
- Keywords
- Graston technique, muscle stiffness, trapezius, oxygenation, pain, trigger points
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 2 Apr 2026 (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.
This randomized crossover study aims to address an important gap in manual therapy by examining the acute physiological effects of different Graston Technique application speeds (60 BPM vs. 120 BPM) on the dominant upper trapezius muscle in patients with bruxism. Although the Graston Technique is widely used, the specific impact of application speed on parameters such as muscle stiffness, muscle oxygenation, pressure pain threshold, and pain intensity remains under-investigated. By utilizing a crossover design with a 1-week washout period, this study allows for a precise within-subject comparison of the two speeds. The findings will clarify the optimal application frequency, providing objective data to guide the development of more effective, evidence-based manual therapy protocols for bruxism management.
Detailed description
Background and Rationale: Bruxism is a condition characterized by repetitive jaw muscle activity, which frequently leads to secondary musculoskeletal symptoms in the cervical region, particularly increasing muscle stiffness and pain in the upper trapezius muscle. While Instrument-Assisted Soft Tissue Mobilization (IASTM), specifically the Graston Technique, is a widely utilized intervention for managing myofascial restrictions, the optimal application parameters remain unclear. Specifically, the physiological impact of the application speed (frequency) on tissue properties and hemodynamics has not been systematically investigated in this population.
Study Design and Protocol: This study utilizes a prospective, randomized, crossover design to evaluate the acute effects of two different Graston Technique application speeds. A total of 36 participants diagnosed with bruxism will be included. Using a block randomization method, participants will be assigned to one of two intervention sequences (AB or BA) to ensure a balanced distribution.
Intervention Protocol: The study targets the dominant upper trapezius muscle. Each participant will complete two sessions separated by a 1-week washout period to prevent carry-over effects. The interventions are as follows:
Slow Speed Application (60 BPM): The Graston technique will be applied at a frequency of 60 beats per minute (1 Hz).
Fast Speed Application (120 BPM): The Graston technique will be applied at a frequency of 120 beats per minute (2 Hz).
For both conditions, the application speed will be standardized and controlled using a metronome. The duration of the intervention is set to 5 minutes per session. The application pressure will be kept consistent by the same physiotherapist throughout the study.
Outcome Measures: Assessments will be performed immediately before (pre-intervention) and immediately after (post-intervention) each session to measure acute changes. The following parameters will be evaluated:
Muscle Stiffness and Tone: Evaluated objectively using an ultrasound shear wave elastography to assess viscoelastic properties.
Muscle Oxygenation: Hemodynamic changes (tissue oxygenation index) will be monitored using Near-Infrared Spectroscopy (NIRS).
Pressure Pain Threshold (PPT): Assessed using an algometer to quantify mechanical pain sensitivity.
Pain Intensity: Subjective pain levels will be rated by participants using a Visual Analog Scale (VAS).
This study aims to determine whether a specific application speed provides superior physiological benefits, thereby contributing to the development of evidence-based manual therapy protocols for patients with bruxism.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomized into two sequences using block randomization. Sequence AB: Participants receive the Slow Application (60 BPM) in the first session, followed by a 1-week washout period, and then receive the Fast Application (120 BPM) in the second session. Sequence BA: Participants receive the Fast Application (120 BPM) in the first session, followed by a 1-week washout period, and then receive the Slow Application (60 BPM) in the second session. Interventions are applied to the dominant upper trapezius muscle.
| Arm | Type | Receives |
|---|---|---|
| Sequence A slow then fast | Experimental | Behavioral: Graston Technique 60 BPMParticipants assigned to this sequence will receive the Graston Technique application at a slow speed (60 BPM) in the first session. After a mandatory 1-week washout period to prevent carry-over effects, they will cross over to receive the Graston Technique application at a fast speed (120 BPM) in the second session. |
| Sequence B fast then slow | Experimental | Behavioral: Graston Technique 120 BPMParticipants assigned to this sequence will receive the Graston Technique application at a fast speed (120 BPM) in the first session. After a mandatory 1-week washout period to prevent carry-over effects, they will cross over to receive the Graston Technique application at a slow speed (60 BPM) in the second session. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosed with bruxism.
- Aged 18-55 years.
- Presence of trigger points in the trapezius muscle, according to the criteria defined by Travell and Simons.
Key exclusion criteria (4 listed)
- Acute tears, tendon ruptures, or severe muscle injuries.
- Conditions that prevent the application of the Graston Technique (e.g., skin lesions, open wounds, infections).
- Having received botox injections in the temporomandibular joint (TMJ) region within the last 6 months.
- Psychological disorders that may affect participation or measurements.
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 |
|---|---|---|
| Graston Technique 60 BPMGT1 and GT4 instruments will be applied using different strokes. To prepare the participant's tissue, the clinician will perform a light-intensity sweeping stroke with the GT1 instrument for 1 minute. Next, the tissue around the trigger points will be treated with a fanning stroke using the GT4 instrument for 2 minutes. Finally, the marked trigger points will be treated with a swivel stroke using the button end of the GT1 instrument for 2 minutes. During the application, the participant will sit upright with their arms resting on their thighs. The instruments will be applied at a 30 to 60-degree angle using multidirectional strokes. The application speed will be controlled using a metronome and performed at 60 beats per minute (BPM). | Behavioural | Sequence A slow then fast |
| Graston Technique 120 BPMGT1 and GT4 instruments will be applied using different strokes. To prepare the participant's tissue, the clinician will perform a light-intensity sweeping stroke with the GT1 instrument for 1 minute. Next, the tissue around the trigger points will be treated with a fanning stroke using the GT4 instrument for 2 minutes. Finally, the marked trigger points will be treated with a swivel stroke using the button end of the GT1 instrument for 2 minutes. During the application, the participant will sit upright with their arms resting on their thighs. The instruments will be applied at a 30 to 60-degree angle using multidirectional strokes. The application speed will be controlled using a metronome and performed at 120 beats per minute (BPM). | Behavioural | Sequence B fast then slow |
Primary outcome
Muscle stiffness
Time frame: Baseline and immediately post-intervention for each treatment session
Shear Wave Elastography (SWE), an ultrasound-based imaging method, will be used to assess muscle stiffness in the participants. Ultrasonography will be performed using a high-resolution LOGIQ P10 device (ML6-15-RS; GE Healthcare Inc., Chicago, IL, USA). During the examination, L3-12 Hd and L8-18i linear probes will be used. To measure upper trapezius muscle stiffness, the ultrasound probe will be placed 2 cm lateral to the midpoint between the acromion of the scapula and the spinous process of the seventh cervical vertebra (C7). Measurements will be taken when several muscle fascicles are visible continuously along the imaging plane. Each measurement will be repeated three times for the assessed muscle, and stiffness parameters will be calculated quantitatively. The average of the three measurements will be recorded in meters per second (m/s).
Muscle oxygenation
Time frame: Baseline and immediately post-intervention for each treatment session
Using near-infrared spectroscopy (NIRS) to evaluate trapezius muscle oxygen levels. Measurements will be performed both at rest and during muscle contraction. The measurement area will be shaved if necessary to prevent errors caused by hair. The area will then be cleaned with a cotton pad soaked in 70% alcohol solution. Participants will be seated with their feet flat on the floor, knees and hips flexed at 90°, and arms resting loosely on their thighs. For the upper trapezius muscle, the location of the probe will be determined as the midpoint of the line extending from the acromion to the spinous process of the C7 vertebra.
2 secondary outcomes
Pressure pain threshold
Time frame: Baseline and immediately post-intervention for each treatment session
Pain intensity
Time frame: Baseline and immediately post-intervention for each treatment session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Graston Technique 60 BPM and Graston Technique 120 BPM in people with Bruxism, run by Gazi University at 1 site in Turkey (Türkiye).
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 3 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: finished, as of the sponsor's last update on 21 Jul 2026. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle stiffness (time frame: Baseline and immediately post-intervention for each treatment session). The study lists 2 primary outcomes in all. 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 21 Jul 2026.