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

NCT02295644 | Completed Results

• 1 other identifier: SUNYBuffalo
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Temporomandibular Joint Dysfunction Syndrome

Keywords

Therapeutic ultrasound

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (4)

A: 0.4 Watts/Sq cm 50% Duty cycle

EXPERIMENTAL

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

B: 0.4 Watts/Sq cm 100% Duty cycle

EXPERIMENTAL

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

C: 0.8 Watts/Sq cm 50% Duty cycle

EXPERIMENTAL

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

D: 0.8 Watts/Sq cm 100% Duty cycle

EXPERIMENTAL

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

Interventions

Ultrasound Sonicator 740 DEVICE

Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes

A: 0.4 Watts/Sq cm 50% Duty cycle; B: 0.4 Watts/Sq cm 100% Duty cycle; C: 0.8 Watts/Sq cm 50% Duty cycle; D: 0.8 Watts/Sq cm 100% Duty cycle

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

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 Dysfunction Syndrome

Condition Hierarchy (Ancestors)

Temporomandibular Joint Disorders; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Myofascial Pain Syndromes; Stomatognathic Diseases

Limitations and Caveats

Three subjects who met the inclusion criteria on recruitment (bilateral masseter pain of four or more) did not meet the criteria at the time of the experiment so were not analyzed.

Results Point of Contact

• Title: Dr. Willard D McCall
• Organization: University at Buffalo, School of Dental Medicine, Oral Diagnostic Sciences

wdmccall@buffalo.edu

(716)829-3559

Study Officials

• Willard McCall

  State University of New York at Buffalo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 17, 2014
• First Posted: November 20, 2014
• Study Start: November 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: October 1, 2015
• Last Updated: June 7, 2018
• Results First Posted: October 7, 2016

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)