Immediate Effect of Ultrasound Therapy on Bilateral Masseter Myalgia

Temporomandibular Joint Dysfunction Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02892994
• Other study ID #: Ultrasound Project #2
• Status: Completed
• Phase: N/A
• First received: May 6, 2016
• Last updated: September 1, 2016
• Start date: April 2016
• Est. completion date: June 2016

Study information

• Verified date: September 2016
• Source: State University of New York at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Joint Diseases
• Myalgia
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Other:
• ultrasound

Locations

Country	Name	City	State
United States	School of Dental Medicine	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
State University of New York at Buffalo

Country where clinical trial is conducted

United States, 

References & 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 Group†. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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..	No
Primary	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.	No
Primary	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.	No
Primary	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.	No