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.

Study Overview

• Status: Completed
• Conditions: Adult Females; Bilateral Masseter Myalgia
• Intervention / Treatment: Procedure: Therapeutic ultrasound

Detailed Description

See brief summary.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14214
      • School of Dental Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: The 1 MHz group; The 1 MHz group will receive therapeutic ultrasound at the 1 MHz setting.	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.
EXPERIMENTAL: The 3 MHz group; The 3 MHz group will receive therapeutic ultrasound at the 3 MHz setting.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

• Sponsor: State University of New York at Buffalo
• Investigators: Principal Investigator: W. D. McCall, Ph.D., State University of New York at Buffalo

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 24, 2019
• Primary Completion (ACTUAL): March 20, 2020
• Study Completion (ACTUAL): March 20, 2021

Study Registration Dates

• First Submitted: September 10, 2019
• First Submitted That Met QC Criteria: September 10, 2019
• First Posted (ACTUAL): September 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 7, 2022
• Last Update Submitted That Met QC Criteria: April 6, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: temporomandibular disorders; masseter myalgia; adult female
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Myalgia
• Other Study ID Numbers: Study00001683

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: De-identified data may be shared after analysis completed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No