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

NCT04086862 | Completed

• 1 other identifier: Study00001683
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adult Females; Bilateral Masseter Myalgia

Keywords

temporomandibular disorders; masseter myalgia; adult female

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (2)

The 1 MHz group

ACTIVE COMPARATOR

The 1 MHz group will receive therapeutic ultrasound at the 1 MHz setting.

Procedure: Therapeutic ultrasound

The 3 MHz group

EXPERIMENTAL

The 3 MHz group will receive therapeutic ultrasound at the 3 MHz setting.

Procedure: Therapeutic ultrasound

Interventions

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.

The 1 MHz group; The 3 MHz group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

School of Dental Medicine

Buffalo, New York, 14214, United States

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Ultrasonic Therapy

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Diathermy; Hyperthermia, Induced; Therapeutics

Study Officials

• W. D. McCall, Ph.D.

  State University of New York at Buffalo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The frequency setting on the ultrasound machine will be set and known only to the principal investigator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Subjects will be randomized to double-blind treatment with 1 MHz or 3 MHz therapeutic ultrasound.

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 12, 2019
• Study Start: October 24, 2019
• Primary Completion: March 20, 2020
• Study Completion: March 20, 2021
• Last Updated: April 7, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)