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

Not Applicable

Completed

• Conditions: Adult Females; Bilateral Masseter Myalgia
• Interventions: Procedure: Therapeutic ultrasound

• Registration Number: NCT04086862
• Lead Sponsor: State University of New York at Buffalo

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.

Detailed Description

See brief summary.

Study Timeline

• Study First Submitted: 2019-09-10
• Study First Submitted QC: 2019-09-10
• Study First Posted: 2019-09-12
• Study Start: 2019-10-24
• Primary Completion: 2020-03-20
• Study Completion: 2021-03-20
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-06
• Last Update Posted: 2022-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The 3 MHz group	Therapeutic ultrasound	The 3 MHz group will receive therapeutic ultrasound at the 3 MHz setting.
The 1 MHz group	Therapeutic ultrasound	The 1 MHz group will receive therapeutic ultrasound at the 1 MHz setting.

Primary Outcome Measures

Name	Time	Method
Reduction in masseter pain by pressure pain threshold.	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)..
Reduction in masseter pain by visual analog pain scale.	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).

Trial Locations

Locations (1)

School of Dental Medicine; 🇺🇸 Buffalo, New York, United States