Clinical trial NCT02018770: Effect of Phototherapy in Individuals With Temporomandibular Disorder.
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Temporomandibular Disorder.
Keywords: Temporomandibular Disorders, Electromyogram,
Modalities of physiotherapy,
Temporomandibular dysfunction syndrome,
Lasers.
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2013-12-23
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%.


Eligibility criteria: 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.

Primary outcomes:
measure: Pain intensity.
timeFrame: 1 year
Secondary outcomes:
measure: Electromyographic activity
timeFrame: 1 year
Other outcomes:
measure: Analysis of superficial cutaneous temperature
timeFrame: 1 year
Locations:
city: Sao Paulo
country: Brazil
facility: University of Nove de Julho
state: São Paulo
Study officials:
affiliation: University of Nove de Julho
name: Daniela Ap Biasotto-Gonzalez, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Herpich CM, Leal-Junior ECP, Gomes CAFP, Gloria IPDS, Amaral AP, Amaral MFRS, Politti F, Biasotto-Gonzalez DA. Immediate and short-term effects of phototherapy on pain, muscle activity, and joint mobility in women with temporomandibular disorder: a randomized, double-blind, placebo-controlled, clinical trial. Disabil Rehabil. 2018 Sep;40(19):2318-2324. doi: 10.1080/09638288.2017.1336648. Epub 2017 Jun 11.
citation: Herpich CM, Leal-Junior EC, Amaral AP, Tosato Jde P, Gloria IP, Garcia MB, Barbosa BR, El Hage Y, Arruda EE, Gomes CA, Rodrigues MS, de Sousa DF, de Carvalho Pde T, Bussadori SK, Gonzalez Tde O, Politti F, Biasotto-Gonzalez DA. Effects of phototherapy on muscle activity and pain in individuals with temporomandibular disorder: a study protocol for a randomized controlled trial. Trials. 2014 Dec 16;15:491. doi: 10.1186/1745-6215-15-491.