- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07506733
Effects of Different Graston Technique Application Speeds on Trapezius Muscle Stiffness, Pressure Pain Threshold, Pain, and Muscle Oxygenation in Patients With Bruxism
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Fadime Gülcan, physiotherapist
- Phone Number: +905412432039
- Email: fztfadimegulcan@gmail.com
Study Contact Backup
- Name: Nihan Karataş, Prof. Dr.
Study Locations
-
-
-
Ankara, Turkey (Türkiye)
- Recruiting
- Gazi University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Diagnosed with bruxism.
- Aged 18-55 years.
- Presence of trigger points in the trapezius muscle, according to the criteria defined by Travell and Simons.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sequence A slow then fast
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.
|
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). |
|
Experimental: Sequence B fast then slow
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.
|
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). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Baseline and immediately post-intervention for each treatment session
|
|
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.
|
Baseline and immediately post-intervention for each treatment session
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pressure pain threshold
Time Frame: Baseline and immediately post-intervention for each treatment session
|
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.
|
Baseline and immediately post-intervention for each treatment session
|
|
Pain intensity
Time Frame: Baseline and immediately post-intervention for each treatment session
|
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.
|
Baseline and immediately post-intervention for each treatment session
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025 - 494
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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