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

Adult Females Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04086862
• Other study ID #: Study00001683
• Status: Completed
• Phase: N/A
• Start date: October 24, 2019
• Est. completion date: March 20, 2021

Study information

• Verified date: April 2022
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

See brief summary.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: March 20, 2021
• Est. primary completion date: March 20, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adult Females
• Bilateral Masseter Myalgia
• Myalgia

Intervention

Procedure:
• Therapeutic ultrasound
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.

Locations

Country	Name	City	State
United States	School of Dental Medicine	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in masseter pain by visual analog pain scale.	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).	Baseline to fifth week.
Primary	Reduction in masseter pain by pressure pain threshold.	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)..	Baseline to fifth week.