Immediate Effect of Ultrasound Therapy on Bilateral Masseter Myalgia

NCT ID: NCT02892994

Last Updated: 2016-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2016-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ultrasound

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

Group Type: EXPERIMENTAL

ultrasound

Intervention Type: OTHER

Placebo

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

Group Type: PLACEBO_COMPARATOR

ultrasound

Intervention Type: OTHER

Interventions

ultrasound

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

State University of New York at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

W.D.McCall, Jr.

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Willard McCall, Ph. D.

Role: PRINCIPAL_INVESTIGATOR

SUNY Buffalo

Locations

School of Dental Medicine

Buffalo, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 24482784 (View on PubMed)

Other Identifiers

Ultrasound Project #2

Identifier Type: -

Identifier Source: org_study_id