Temporomandibular Joint Dysfunction Syndrome
Conditions
Keywords
therapeutic ultrasound
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.
Interventions
OTHERultrasound
Sponsors
State University of New York at Buffalo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed