NCT07506733

Brief 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. 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 25, 2025

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 2, 2026

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

April 2, 2026

Status Verified

October 1, 2025

Enrollment Period

1.1 years

First QC Date

March 24, 2026

Last Update Submit

March 28, 2026

Conditions

Keywords

Graston techniquemuscle stiffnesstrapeziusoxygenationpaintrigger points

Outcome Measures

Primary Outcomes (2)

  • 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).

    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.

    Baseline and immediately post-intervention for each treatment session

Secondary Outcomes (2)

  • Pressure pain threshold

    Baseline and immediately post-intervention for each treatment session

  • Pain intensity

    Baseline and immediately post-intervention for each treatment session

Study Arms (2)

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.

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.

Behavioral: Graston Technique 120 BPM

Interventions

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).

Sequence A slow then fast

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).

Sequence B fast then slow

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosed with bruxism.
  • Aged 18-55 years.
  • Presence of trigger points in the trapezius muscle, according to the criteria defined by Travell and Simons.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

BruxismPain

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesHabitsBehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Fadime Gülcan, physiotherapist

CONTACT

Nihan Karataş, Prof. Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
physiotherapist

Study Record Dates

First Submitted

March 24, 2026

First Posted

April 2, 2026

Study Start

March 25, 2025

Primary Completion

April 30, 2026

Study Completion

April 30, 2026

Last Updated

April 2, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations