Immediate Effect of Ultrasound Therapy on Bilateral Masseter Myalgia

NCT02892994 | Completed

• 1 other identifier: Ultrasound Project #2
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare ultrasound 0.4 W/cm\^2 and 100% duty cycle versus no ultrasound (placebo) for bilateral masseter myalgia in up to 38 adult women. The dose will be applied for 5 minutes on each side. Both the dose and the starting side will be randomized. Both the subject and ultrasound operator will be blind to the dose. The outcome measures will be pressure pain threshold on both masseter muscles and both temporalis muscles, self reported pain scale (0, no pain to 10, worst pain ever), thermographic temperature of the muscles, and intraoral temperature. These outcome measures will be taken before and after each dose, so three times per subject.

Conditions

Temporomandibular Joint Dysfunction Syndrome

Keywords

therapeutic ultrasound

Outcome Measures

Primary Outcomes (4)

• Pressure pain threshold, change from pre- to post-ultrasound dose.

  The change in pressure pain threshold from before to after the ultrasound (or placebo) will be averaged over the two masseter muscles, and over the two temporalis muscles.

  Immediate. Data taken before and after each dose, so three times in the one session which lasts about one hour to completion..

• Self reported pain scale, change from pre- to post-ultrasound dose which lasts about one hour to completion.

  The change in self reported pain scale from before to after the ultrasound (or placebo) will be averaged over the two masseter muscles, and over the two temporalis muscles.

  Immediate. Data taken before and after each dose, so three times in the one session.

• Intraoral temperature

  The intraoral temperature in the buccal area near the masseter muscle will be recorded before and after the ultrasound

  Immediate. Data taken before and after each dose, so three times in the one session which lasts about one hour to completion.

• Thermographic temperature of the muscles

  The thermographic temperature of each masseter and each temporalis muscle will be recorded before and after the ultrasound.

  Immediate. Data taken before and after each dose, so three times in the one session which lasts about one hour to completion.

Study Arms (2)

Ultrasound

EXPERIMENTAL

Subjects will receive 5 minutes of ultrasound treatment at 0.4 W/cm\^2 and 100% duty cycle on each masseter muscle.

Other: ultrasound

Placebo

PLACEBO COMPARATOR

Subjects will receive 5 minutes of ultrasound treatment at zero power on each masseter muscle.

Other: ultrasound

Interventions

ultrasound OTHER

Placebo; Ultrasound

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) (Schiffman, et al., 2014) 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:

• History or diagnosis of systemic musculoskeletal disorders. Rheumatologic diseases (e.g. fibromyalgia, muscular atrophy). Certain conditions such as neoplasms or fractures. Neuropathies or neurological disorders. Currently taking muscle relaxants or analgesics. 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

Related Publications (1)

• Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151.

  PMID: 24482784 BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint Dysfunction Syndrome

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Willard McCall, Ph. D.

  SUNY Buffalo

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 6, 2016
• First Posted: September 8, 2016
• Study Start: April 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: September 8, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)