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Introduction. Temporomandibular disorders (TMD) are a group of conditions that are multifactorial in nature, and it primarily presents with symptoms of pain and decreased functional capacity. Therapeutic ultrasound is a method of physical therapy that has shown clinically to provide immediate relief of pain in patients with different musculoskeletal disorders. In this study, for the purpose of immediate management of painful masticatory muscle and tissues, the investigators attempt to understand the mechanism of therapeutic ultrasound by exploring the physiologic changes peripherally and centrally. In addition, the investigators aim to determine if there is a dose response relationship between two different intensities (0.4 W/cm2 and 0.8 W/cm2) and between two sets of duty cycles (50% and 100%). A third purpose is to determine if therapeutic ultrasound applied to the masseter muscle is capable of eliciting segmental effects in the temporalis muscle. Methods. A total of 28 adult females with bilateral myalgia according to Diagnostic criteria for TMD (DC/TMD) will be recruited for this investigational trial. Each subject will be randomly allocated to one of the four ultrasound intervention groups each of which has different settings. Using Sonicator®740, therapeutic ultrasound intervention will be performed on both masseters for five minutes on each side of the face. A template will be used to confine the borders of the muscle and to determine the sites for the repeated outcome measures. Outcome parameters of: self-reported pain scale, pressure pain threshold, electromyographic muscle amplitudes and intraoral muscle temperatures will be measured for masseter and temporalis muscles on each side of the face, and will be assessed at baseline and after intervention on each side.
The "Brief Summary" above encompasses the detailed description.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: 0.4 Watts/Sq cm 50% Duty cycle | Experimental | 0.4 Watts/Sq cm 50% Duty cycle Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1 (MegaHertz) MHz, 5 minutes |
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| B: 0.4 Watts/Sq cm 100% Duty cycle | Experimental | 0.4 Watts/Sq cm 100% Duty cycle Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1 MHz, 5 minutes |
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| C: 0.8 Watts/Sq cm 50% Duty cycle | Experimental | 0.8 Watts/Sq cm 50% Duty cycle Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1 MHz, 5 minutes |
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| D: 0.8 Watts/Sq cm 100% Duty cycle | Experimental | 0.8 Watts/Sq cm 100% Duty cycle Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1 MHz, 5 minutes |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound Sonicator 740 | Device | Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Self Report of Pain | Pain intensity measurement scale from 0 to 10, 0 is no pain, 10 is the worst pain ever | Immediately before and after the intervention, difference used. |
| Pressure Pain Threshold of the Masseter Muscle | Measuring pressure pain threshold using digital algometer | Immediately before and after the intervention, difference used. |
| Intraoral Muscle Temperature | Using digital thermometer on buccal mucosa, degrees celsius. | Immediately before and after the intervention, difference used. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Willard McCall | State University of New York at Buffalo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Dental Medicine | Buffalo | New York | 14214 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | A (0.4W/Square Centimeter, 50%) | 0.4 Watts/Sq cm 50% Duty cycle Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes |
| FG001 | B (0.4W/Square Centimeter, 100%) | 0.4 Watts/Sq cm 100% Duty cycle Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes |
| FG002 | C (0.8W/Square Centimeter, 50%) | 0.8 Watts/Sq cm 50% Duty cycle Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes |
| FG003 | D (0.8W/Square Centimeter, 100%) | 0.8 Watts/Sq cm 100% Duty cycle Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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One in group C and two in group D did not meet inclusion criterion of reporting current pain intensity of ≥4 on the Diagnostic Criteria for TMD.
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| ID | Title | Description |
|---|---|---|
| BG000 | A(0.4W/Square Centimeter, 50%) | 0.4 Watts/Sq cm 50% Duty cycle Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes |
| BG001 | B(0.4W/Square Centimeter, 100%) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Self Report of Pain | Pain intensity measurement scale from 0 to 10, 0 is no pain, 10 is the worst pain ever | Posted | Mean | Standard Deviation | Scores on pain intensity scale | Immediately before and after the intervention, difference used. |
|
Throughout the trial of one hour.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A(0.4W/Square Centimeter, 50%) | 0.4 Watts/Sq cm 50% Duty cycle Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes |
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Three subjects who met the inclusion criteria on recruitment (bilateral masseter pain of four or more) did not meet the criteria at the time of the experiment so were not analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Willard D McCall | University at Buffalo, School of Dental Medicine, Oral Diagnostic Sciences | (716)829-3559 | wdmccall@buffalo.edu |
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| ID | Term |
|---|---|
| D013706 | Temporomandibular Joint Dysfunction Syndrome |
| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
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0.4 Watts/Sq cm 100% Duty cycle
Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes
| BG002 | C (0.8W/Square Centimeter, 50%) | 0.8 Watts/Sq cm 50% Duty cycle Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes |
| BG003 | D (0.8W/Square Centimeter, 100%) | 0.8 Watts/Sq cm 100% Duty cycle Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 |
| C (0.8W/Square Centimeter, 50%) |
0.8 Watts/Sq cm 50% Duty cycle Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes |
| OG003 | D (0.8W/Square Centimeter, 100%) | 0.8 Watts/Sq cm 100% Duty cycle Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes |
|
|
|
| Primary | Pressure Pain Threshold of the Masseter Muscle | Measuring pressure pain threshold using digital algometer | Posted | Mean | Standard Deviation | Kpa/Cm^2 | Immediately before and after the intervention, difference used. |
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|
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| Primary | Intraoral Muscle Temperature | Using digital thermometer on buccal mucosa, degrees celsius. | Posted | Mean | Standard Deviation | degrees Celsius, post minus pre | Immediately before and after the intervention, difference used. |
|
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | B(0.4W/Square Centimeter, 100%) | 0.4 Watts/Sq cm 100% Duty cycle Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes | 0 | 7 | 0 | 7 |
| EG002 | C(0.8W/Square Centimeter, 50%) | 0.8 Watts/Sq cm 50% Duty cycle Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes | 0 | 6 | 0 | 6 |
| EG003 | D (0.8W/Square Centimeter, 100%) | 0.8 Watts/Sq cm 100% Duty cycle Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes | 0 | 5 | 0 | 5 |
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| D009140 | Musculoskeletal Diseases |
| D007592 | Joint Diseases |
| D009135 | Muscular Diseases |
| D009209 | Myofascial Pain Syndromes |
| D009057 | Stomatognathic Diseases |
| 0.019 |
Main effect for intensity. |
| Superiority or Other |
| Interaction of intensity and duty cycle. | ANOVA | 0.17 | Superiority or Other |
| 0.475 |
| Superiority or Other |
| Interaction of intensity and duty cycle. | ANOVA | .178 | Superiority or Other |