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Completed

NCT Number: NCT02892994

Immediate Effect of Ultrasound Therapy on Bilateral Masseter Myalgia

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

School of Dental Medicine

Buffalo, New York, 14214, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

ultrasound

Other

Primary outcomes

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

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

    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.

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

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

    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.

  3. Intraoral temperature

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

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

  4. Thermographic temperature of the muscles

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

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

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Sep 8, 2016
Registry last updated
Sep 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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