Clinical trial NCT02892994: Immediate Effect of Ultrasound Therapy on Bilateral Masseter Myalgia
Official title: Immediate Effect of Ultrasound Therapy on Bilateral Masseter Myalgia: A Randomized Double Blinded Investigational Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Joint Dysfunction Syndrome
Keywords: therapeutic ultrasound
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pressure pain threshold, change from pre- to post-ultrasound dose.
timeFrame: Immediate. Data taken before and after each dose, so three times in the one session which lasts about one hour to completion..
measure: Self reported pain scale, change from pre- to post-ultrasound dose which lasts about one hour to completion.
timeFrame: Immediate. Data taken before and after each dose, so three times in the one session.
measure: Intraoral temperature
timeFrame: Immediate. Data taken before and after each dose, so three times in the one session which lasts about one hour to completion.
measure: Thermographic temperature of the muscles
timeFrame: Immediate. Data taken before and after each dose, so three times in the one session which lasts about one hour to completion.
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: School of Dental Medicine
state: New York
Study officials:
affiliation: SUNY Buffalo
name: Willard McCall, Ph. D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.