Temporomandibular Disorder. Clinical Trial
Official title:
Effect of Phototherapy on Pain, Muscles Activity and Joint Mobility in Individuals With Temporomandibular Disorder: A Randomized, Placebo-Controlled and Double-Blind Clinical Trial.
| Verified date | January 2014 |
| Source | University of Nove de Julho |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The present study aims to evaluate the effect of phototherapy with the combination of different sources of light on pain, activity of temporal and masseter muscles, bilateral and joint mobility in subjects with TMD. It will be made a randomized, placebo-controlled and double-blind clinical trial. Individuals participate with myogenic temporomandibular disorder, being allocated into 4 groups randomly and stratified by the method of sealed envelopes. The results will be evaluated using: RDC/TMD, digital caliper, electromyography, and visual analog scale and algometry. The protocols will be used in a single session and will be evaluated in four different moments. The variables that will be investigated are pain, muscle activity and joint mobility. The analyses of the data will be performed by adopting a significance level of 5%.
| Status | Unknown status |
| Enrollment | 48 |
| Est. completion date | December 2014 |
| Est. primary completion date | September 2014 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 40 Years |
| Eligibility |
Inclusion Criteria: - 18 to 40 years. - Female volunteers. - Diagnosis of myogenic TMD pain must masseter presenting moderate to severe according to the RDC / TMD. - Display body mass index (BMI) less than 25 kg/m2 to standardize the sample. - In addition, volunteers must submit scores of pain greater than 3 cm according to the Visual Analog Scale masticatory muscles. Exclusion Criteria: - history of neurological disorders. - chronic neck pain resulting from a traumatic incident. - chronic musculoskeletal condition. - medical diagnosis of fibromyalgia; systemic disease. - connective tissue disorder. - having undergone physical therapy use of analgesic, muscle relaxant. |
| Country | Name | City | State |
|---|---|---|---|
| Brazil | University of Nove de Julho | Sao Paulo | São Paulo |
| Lead Sponsor | Collaborator |
|---|---|
| University of Nove de Julho |
Brazil,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Analysis of superficial cutaneous temperature | A thermal camera model FLIR T450 ® SC Systems (Stockholm, Sweden) is used to measure the surface skin temperature of the masseter and temporal muscles to verify the effect of phototherapy in them. | 1 year | |
| Primary | Pain intensity. | Will be used a algometry D-200 of Instrutherm ®, which is a semi quantitative method to measure the intensity of the pain by the pressure, find painful spots, in addition to quantify changes the various pain syndromes. | 1 year | |
| Secondary | Electromyographic activity | The electrical powers of masticatory muscles will be verified in this study through surface electromyography, specifically the masseter and temporal muscles, serving as a useful tool to quantify muscle activity during Mastication and thus identify its functional changes. | 1 year |