Immediate Effect of Ultrasound Therapy on Bilateral Masseter Myalgia

Not Applicable

Completed

• Conditions: Temporomandibular Joint Dysfunction Syndrome
• Interventions: Other: ultrasound

• Registration Number: NCT02892994
• Lead Sponsor: State University of New York at Buffalo

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-05-06
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-09
• Study First Submitted QC: 2016-09-01
• Last Update Submitted: 2016-09-01
• Study First Posted: 2016-09-08
• Last Update Posted: 2016-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 23

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound	ultrasound	Subjects will receive 5 minutes of ultrasound treatment at 0.4 W/cm\^2 and 100% duty cycle on each masseter muscle.
Placebo	ultrasound	Subjects will receive 5 minutes of ultrasound treatment at zero power on each masseter muscle.

Primary Outcome Measures

Name	Time	Method
Pressure pain threshold, change from pre- to post-ultrasound dose.	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.
Self reported pain scale, change from pre- to post-ultrasound dose which lasts about one hour to completion.	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.
Intraoral temperature	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
Thermographic temperature of the muscles	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.

Trial Locations

Locations (1)

School of Dental Medicine; 🇺🇸 Buffalo, New York, United States