An interventional study of Graston Technique 60 BPM and Graston Technique 120 BPM in Bruxism, sponsored by Gazi University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by Gazi University · Not applicable, Interventional, and Supportive care
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.
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.
151 studies on the registry are indexed under Bruxism; 39 are open to participants now.
This study's enrollment of 36 is close to the median of 39 across 94 interventional studies indexed under Bruxism.
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Exclusion Criteria:
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.
Behavioral: Graston Technique 60 BPM
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.
Behavioral: Graston Technique 120 BPM
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).
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).
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).
Time frame: 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.
Time frame: Baseline and immediately post-intervention for each treatment session
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.
Time frame: 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.
Time frame: Baseline and immediately post-intervention for each treatment session
Plan to share: No
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