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OpenTrials
Completed

NCT Number: NCT04086862

Effect of Ultrasound Therapy on Bilateral Masseter Myalgia: Comparison of 1 Megahertz Versus 3 Megahertz

Temporomandibular disorders (TMD) are a group of musculoskeletal and neuromuscular conditions that involve the temporomandibular joints, the masticatory muscles, and all associated tissues. These disorders are characterized by regional pain and limitation of mandibular range of motion. Pain-related TMD affects approximately 5% to 12% of the population and can affect individual's quality of life. The incidence is about 4 percent. Therapeutic ultrasound is a type of physical therapy that delivers energy via propagation of ultrasonic waves. One gap in knowledge is whether 1 megahertz (MHz) treating frequency has the same efficacy as treating with 3 MHz. This research proposes to test that.

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Key information

Conditions

Adult Females Bilateral Masseter Myalgia Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Stomatognathic Diseases Temporomandibular Joint Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

School of Dental Medicine

Buffalo, New York, 14214, United States

About this study

See brief summary.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult females
  • Bilateral myalgia based on Diagnostic Criteria for TMD (DC-TMD) criteria
  • An average pain of 5 or more on a 0 to 10 scale over the last 30 days.

Exclusion criteria

  • A history or diagnosis of systemic musculoskeletal disorders or rheumatologic diseases (e.g. fibromyalgia, muscular atrophy).
  • Certain conditions such as neoplasms or fractures.
  • Neuropathies or neurological disorders.
  • Currently taking muscle relaxants or analgesics.
  • Undergone any form of physical therapy within the last 60 days.
  • Severe bruxism requiring mouth-guard treatment.

Treatment and study plan

Therapeutic ultrasound

Procedure

A commercially available ultrasound machine will provide 5 minutes of ultrasound at 0.4 watt/cm^2 and 100% duty cycle sequentially to each masseter muscle.

Primary outcomes

  1. Reduction in masseter pain by visual analog pain scale.

    Time frame: Baseline to fifth week.

    Reduction in masseter pain as measured on a visual analog scale (VAS). The VAS runs from 0 (no pain at all) to 100 (worst pain imaginable).

  2. Reduction in masseter pain by pressure pain threshold.

    Time frame: Baseline to fifth week.

    Reduction in masseter pain as measured with the pressure pain threshold (VAS). The VAS runs from 0 (no pain at all) to 100 (worst pain imaginable)..

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Sep 12, 2019
Registry last updated
Apr 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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