Temporomandibular Joint Dysfunction Syndrome
Conditions
Keywords
Therapeutic ultrasound
Brief summary
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.
Detailed description
The Brief Summary above encompasses the detailed description.
Interventions
DEVICEUltrasound Sonicator 740
Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes
Sponsors
State University of New York at Buffalo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult females who have bilateral myalgia based on Diagnostic Criteria for TMD (DC-TMD) criteria and current pain intensity (≥4 out of 10, where 0 is no pain and 10 is the worst pain ever) on both sides.
Exclusion criteria
* Those who have a history or were diagnosed with systemic musculoskeletal disorders or rheumatologic diseases (e.g. fibromyalgia, muscular atrophy). * Certain conditions such as neoplasms or fractures. * Neuropathies or neurological disorders. * Participants who are currently taking muscle relaxants or analgesics. * Those who have undergone any form of physical therapy within the last 60 days.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self Report of Pain | Immediately before and after the intervention, difference used. | Pain intensity measurement scale from 0 to 10, 0 is no pain, 10 is the worst pain ever |
| Pressure Pain Threshold of the Masseter Muscle | Immediately before and after the intervention, difference used. | Measuring pressure pain threshold using digital algometer |
| Intraoral Muscle Temperature | Immediately before and after the intervention, difference used. | Using digital thermometer on buccal mucosa, degrees celsius. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 7 |
| 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 | 7 |
| 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 | 6 |
| 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 | 5 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Did not meet inclusion criterion | 0 | 0 | 1 | 2 |
Baseline characteristics
| Characteristic | A(0.4W/Square Centimeter, 50%) | B(0.4W/Square Centimeter, 100%) | C (0.8W/Square Centimeter, 50%) | D (0.8W/Square Centimeter, 100%) | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 7 Participants | 6 Participants | 5 Participants | 25 Participants |
| Region of Enrollment United States | 7 participants | 7 participants | 6 participants | 5 participants | 25 participants |
| Sex: Female, Male Female | 7 Participants | 7 Participants | 6 Participants | 5 Participants | 25 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 7 | 0 / 7 | 0 / 6 | 0 / 5 |
| serious Total, serious adverse events | 0 / 7 | 0 / 7 | 0 / 6 | 0 / 5 |
Outcome results
Primary
Intraoral Muscle Temperature
Using digital thermometer on buccal mucosa, degrees celsius.
Time frame: Immediately before and after the intervention, difference used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A (0.4W/Square Centimeter, 50%) | Intraoral Muscle Temperature | .036 degrees Celsius, post minus pre | Standard Deviation 0.09 |
| B (0.4W/Square Centimeter, 100%) | Intraoral Muscle Temperature | .15 degrees Celsius, post minus pre | Standard Deviation 0.206 |
| C (0.8W/Square Centimeter, 50%) | Intraoral Muscle Temperature | .033 degrees Celsius, post minus pre | Standard Deviation 0.154 |
| D (0.8W/Square Centimeter, 100%) | Intraoral Muscle Temperature | .42 degrees Celsius, post minus pre | Standard Deviation 0.4 |
p-value: 0.034ANOVA
Comparison: Main effect for intensity.p-value: 0.475ANOVA
Comparison: Interaction of intensity and duty cycle.p-value: 0.178ANOVA
Primary
Pressure Pain Threshold of the Masseter Muscle
Measuring pressure pain threshold using digital algometer
Time frame: Immediately before and after the intervention, difference used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A (0.4W/Square Centimeter, 50%) | Pressure Pain Threshold of the Masseter Muscle | -2.64 Kpa/Cm^2 | Standard Deviation 31.79 |
| B (0.4W/Square Centimeter, 100%) | Pressure Pain Threshold of the Masseter Muscle | 15.21 Kpa/Cm^2 | Standard Deviation 5.75 |
| C (0.8W/Square Centimeter, 50%) | Pressure Pain Threshold of the Masseter Muscle | -5.12 Kpa/Cm^2 | Standard Deviation 9.44 |
| D (0.8W/Square Centimeter, 100%) | Pressure Pain Threshold of the Masseter Muscle | -10.2 Kpa/Cm^2 | Standard Deviation 12.04 |
p-value: 0.24ANOVA
p-value: 0.019ANOVA
Comparison: Interaction of intensity and duty cycle.p-value: 0.17ANOVA
Primary
Self Report of Pain
Pain intensity measurement scale from 0 to 10, 0 is no pain, 10 is the worst pain ever
Time frame: Immediately before and after the intervention, difference used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| A (0.4W/Square Centimeter, 50%) | Self Report of Pain | -.86 Scores on pain intensity scale | Standard Deviation 1.4 |
| B (0.4W/Square Centimeter, 100%) | Self Report of Pain | -2.0 Scores on pain intensity scale | Standard Deviation 0.87 |
| C (0.8W/Square Centimeter, 50%) | Self Report of Pain | -1.4 Scores on pain intensity scale | Standard Deviation 1.1 |
| D (0.8W/Square Centimeter, 100%) | Self Report of Pain | -1.3 Scores on pain intensity scale | Standard Deviation 1.4 |
p-value: 0.17ANOVA
p-value: 0.14ANOVA
p-value: 1ANOVA