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NCT02295644 · ClinicalTrials.gov registry record · NA
Immediate Effect of Ultrasound Therapy on Bilateral Masseter Myalgia: Randomized Single Blinded Investigational Trial
A NA study, sponsored by State University of New York at Buffalo.
- Completed
- Registry status
- NA
- Development phase
- 28
- Enrollment target
NCT02295644 is a NA study that has completed, run by State University of New York at Buffalo. The registered enrollment target is 28 participants.
The verdict
NCT02295644, a NA study, has completed, sponsored by State University of New York at Buffalo.
- COMPLETED
- Registry status
- NA
- Development phase
- 28 participants
- Enrollment target
Study 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.
Interventions
- DEVICE Ultrasound Sonicator 740
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2014-11 |
| Est. Completion | 2015-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02295644
The ClinicalTrials.gov registry entry for NCT02295644 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is State University of New York at Buffalo, which has 243 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ultrasound Sonicator 740 is the first listed.
NCT02295644 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02295644 about?
NCT02295644 is a clinical study titled "Immediate Effect of Ultrasound Therapy on Bilateral Masseter Myalgia: Randomized Single Blinded Investigational Trial". 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...
What is the current status of trial NCT02295644?
This trial is currently completed. It is a NA study. The enrollment target is 28 participants. The study started on 2014-11. Estimated completion is 2015-10.
What interventions are being tested in trial NCT02295644?
The interventions under investigation include: Ultrasound Sonicator 740 (DEVICE).
Who is sponsoring clinical trial NCT02295644?
This trial is sponsored by State University of New York at Buffalo, which has 243 total clinical trials registered on ClinicalTrials.gov.
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