search
Back to results

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

Primary Purpose

Adult Females, Bilateral Masseter Myalgia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Therapeutic ultrasound
Sponsored by
State University of New York at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Females focused on measuring temporomandibular disorders, masseter myalgia, adult female

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • School of Dental Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

The 1 MHz group

The 3 MHz group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).
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)..

Secondary Outcome Measures

Full Information

First Posted
September 10, 2019
Last Updated
April 6, 2022
Sponsor
State University of New York at Buffalo
search

1. Study Identification

Unique Protocol Identification Number
NCT04086862
Brief Title
Effect of Ultrasound Therapy on Bilateral Masseter Myalgia: Comparison of 1 Megahertz Versus 3 Megahertz
Official Title
Effect of Ultrasound Therapy on Bilateral Masseter Myalgia: Comparison of 1 Megahertz Versus 3 Megahertz
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 24, 2019 (Actual)
Primary Completion Date
March 20, 2020 (Actual)
Study Completion Date
March 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Females, Bilateral Masseter Myalgia
Keywords
temporomandibular disorders, masseter myalgia, adult female

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be randomized to double-blind treatment with 1 MHz or 3 MHz therapeutic ultrasound.
Masking
ParticipantCare Provider
Masking Description
The frequency setting on the ultrasound machine will be set and known only to the principal investigator.
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The 1 MHz group
Arm Type
Active Comparator
Arm Description
The 1 MHz group will receive therapeutic ultrasound at the 1 MHz setting.
Arm Title
The 3 MHz group
Arm Type
Experimental
Arm Description
The 3 MHz group will receive therapeutic ultrasound at the 3 MHz setting.
Intervention Type
Procedure
Intervention Name(s)
Therapeutic ultrasound
Intervention Description
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 Outcome Measure Information:
Title
Reduction in masseter pain by visual analog pain scale.
Description
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).
Time Frame
Baseline to fifth week.
Title
Reduction in masseter pain by pressure pain threshold.
Description
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)..
Time Frame
Baseline to fifth week.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
W. D. McCall, Ph.D.
Organizational Affiliation
State University of New York at Buffalo
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Dental Medicine
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
De-identified data may be shared after analysis completed.

Learn more about this trial

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

We'll reach out to this number within 24 hrs