Immediate Effect of Ultrasound Therapy on Bilateral Masseter Myalgia: Randomized Single Blinded Investigational Trial
| Status: | Completed |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/9/2018 |
| Start Date: | November 2014 |
| End Date: | October 2015 |
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.
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.
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.
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