Effect of Phototherapy in Individuals With Temporomandibular Disorder.
Effect of Phototherapy on Pain, Muscles Activity and Joint Mobility in Individuals With Temporomandibular Disorder: A Randomized, Placebo-Controlled and Double-Blind Clinical Trial.
1 other identifier
interventional
48
1 country
1
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%.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jan 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2013
CompletedFirst Posted
Study publicly available on registry
December 23, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedMarch 11, 2014
January 1, 2014
8 months
December 17, 2013
March 10, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Electromyographic activity
1 year
Other Outcomes (1)
Analysis of superficial cutaneous temperature
1 year
Study Arms (2)
Phototherapy
EXPERIMENTALThree 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) .
Placebo phototherapy
PLACEBO COMPARATORThe 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.
Interventions
Portable Cluster 9 PainAway ® diodes manufactured by Multi Radiance Medical ® (Solon, OH-USA), being 1 905 nm diode (1 mW average power 10 W of peak power, spot of 0.44 cm2), 875 nm diodes 4 (17.5 mW average power for each diode, spot of 1 cm2) and 670 nm diodes 4 (15 mW average power for each diode1 spot, cm2), frequency of 1000 Hz, irradiation time of 300 seconds, energy delivered from 39.3 Joules.
The volunteers will be subjected to the same Groups ' intervention and placebo pen Phototherapy.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Nove de Julho
São Paulo, São Paulo, 01415000, Brazil
Related Publications (2)
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.
PMID: 28602137DERIVEDHerpich 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.
PMID: 25514875DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniela Ap Biasotto-Gonzalez, Doctor
University of Nove de Julho
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Doctor
Study Record Dates
First Submitted
December 17, 2013
First Posted
December 23, 2013
Study Start
January 1, 2014
Primary Completion
September 1, 2014
Study Completion
December 1, 2014
Last Updated
March 11, 2014
Record last verified: 2014-01