Effect of Phototherapy on Pain, Muscles Activity and Joint Mobility in Individuals With Temporomandibular Disorder: A Randomized, Placebo-Controlled and Double-Blind Clinical Trial.
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- University of Nove de Julho
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Pain intensity.
Study Overview
Brief Summary
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%.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Phototherapy
Three groups will receive different fototerapia of light sources, and group 1 will not receive dose: Group A (0, 65Joules), Group B (1.30 Joules) and Group C (1.95 Joules) .
Intervention: Phototherapy (Radiation)
Placebo phototherapy
The volunteers will be subjected to the same Groups intervention Phototherapy . The but researcher will receive placebo pen. It is the caveat that, after completed the voluntary participation, will be held with the active pen treatment.
Intervention: Placebo phototherapy (Radiation)
Outcomes
Primary Outcomes
Pain intensity.
Time Frame: 1 year
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.
Secondary Outcomes
- Electromyographic activity(1 year)
Investigators
Daniela Ap. Biasotto-Gonzalez
Doctor
University of Nove de Julho