Immediate Effect of Ultrasound Therapy on Bilateral Masseter Myalgia: Randomized Single Blinded Investigational Trial

Introduction. Temporomandibular disorders (TMD) are a group of conditions that are multifactorial in nature, and it primarily presents with symptoms of pain and decreased functional capacity. Therapeutic ultrasound is a method of physical therapy that has shown clinically to provide immediate relief of pain in patients with different musculoskeletal disorders. In this study, for the purpose of immediate management of painful masticatory muscle and tissues, the investigators attempt to understand the mechanism of therapeutic ultrasound by exploring the physiologic changes peripherally and centrally. In addition, the investigators aim to determine if there is a dose response relationship between two different intensities (0.4 W/cm2 and 0.8 W/cm2) and between two sets of duty cycles (50% and 100%). A third purpose is to determine if therapeutic ultrasound applied to the masseter muscle is capable of eliciting segmental effects in the temporalis muscle. Methods. A total of 28 adult females with bilateral myalgia according to Diagnostic criteria for TMD (DC/TMD) will be recruited for this investigational trial. Each subject will be randomly allocated to one of the four ultrasound intervention groups each of which has different settings. Using Sonicator®740, therapeutic ultrasound intervention will be performed on both masseters for five minutes on each side of the face. A template will be used to confine the borders of the muscle and to determine the sites for the repeated outcome measures. Outcome parameters of: self-reported pain scale, pressure pain threshold, electromyographic muscle amplitudes and intraoral muscle temperatures will be measured for masseter and temporalis muscles on each side of the face, and will be assessed at baseline and after intervention on each side.

Study Overview

• Status: Completed
• Conditions: Temporomandibular Joint Dysfunction Syndrome
• Intervention / Treatment: Device: Ultrasound Sonicator 740

Detailed Description

The "Brief Summary" above encompasses the detailed description.

• Study Type: Interventional
• Enrollment (Actual): 28
• 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: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Adult females who have bilateral myalgia based on Diagnostic Criteria for TMD (DC-TMD) criteria and current pain intensity (≥4 out of 10, where 0 is no pain and 10 is the worst pain ever) on both sides.

Exclusion Criteria:

• Those who have a history or were diagnosed with systemic musculoskeletal disorders or rheumatologic diseases (e.g. fibromyalgia, muscular atrophy).
• Certain conditions such as neoplasms or fractures.
• Neuropathies or neurological disorders.
• Participants who are currently taking muscle relaxants or analgesics.
• Those who have undergone any form of physical therapy within the last 60 days.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A: 0.4 Watts/Sq cm 50% Duty cycle; 0.4 Watts/Sq cm 50% Duty cycle Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1 (MegaHertz) MHz, 5 minutes	Device: Ultrasound Sonicator 740; Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes
Experimental: B: 0.4 Watts/Sq cm 100% Duty cycle; 0.4 Watts/Sq cm 100% Duty cycle Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1 MHz, 5 minutes	Device: Ultrasound Sonicator 740; Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes
Experimental: C: 0.8 Watts/Sq cm 50% Duty cycle; 0.8 Watts/Sq cm 50% Duty cycle Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1 MHz, 5 minutes	Device: Ultrasound Sonicator 740; Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes
Experimental: D: 0.8 Watts/Sq cm 100% Duty cycle; 0.8 Watts/Sq cm 100% Duty cycle Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1 MHz, 5 minutes	Device: Ultrasound Sonicator 740; Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self Report of Pain	Pain intensity measurement scale from 0 to 10, 0 is no pain, 10 is the worst pain ever	Immediately before and after the intervention, difference used.
Pressure Pain Threshold of the Masseter Muscle	Measuring pressure pain threshold using digital algometer	Immediately before and after the intervention, difference used.
Intraoral Muscle Temperature	Using digital thermometer on buccal mucosa, degrees celsius.	Immediately before and after the intervention, difference used.

Collaborators and Investigators

• Sponsor: State University of New York at Buffalo
• Investigators: Principal Investigator: Willard McCall, State University of New York at Buffalo

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: November 17, 2014
• First Submitted That Met QC Criteria: November 19, 2014
• First Posted (Estimate): November 20, 2014

Study Record Updates

• Last Update Posted (Actual): June 7, 2018
• Last Update Submitted That Met QC Criteria: May 7, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Therapeutic ultrasound
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Myalgia; Joint Diseases; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
• Other Study ID Numbers: SUNYBuffalo

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No