Effect of Phototherapy in Individuals With Temporomandibular Disorder.

University of Nove de Julho

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Temporomandibular Disorder.

Treatments: Radiation: Placebo phototherapy; Radiation: Phototherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02018770

18032013.4.0000.5511

Details and patient eligibility

About

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%.

Enrollment: 48 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 2 patient groups, including a placebo group

Phototherapy

Experimental group

Description:

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) .

Treatment:

Radiation: Phototherapy

Placebo phototherapy

Placebo Comparator group

Description:

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.

Treatment:

Radiation: Placebo phototherapy