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Effect of Phototherapy in Individuals With Temporomandibular Disorder.

Primary Purpose

Temporomandibular Disorder.

Status
Unknown status
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Phototherapy
Placebo phototherapy
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Disorder. focused on measuring Temporomandibular Disorders, Electromyogram,, Modalities of physiotherapy,, Temporomandibular dysfunction syndrome,, Lasers.

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • University of Nove de JulhoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Phototherapy

Placebo phototherapy

Arm 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) .

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 17, 2013
Last Updated
March 10, 2014
Sponsor
University of Nove de Julho
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1. Study Identification

Unique Protocol Identification Number
NCT02018770
Brief Title
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

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2014 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nove de Julho

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorder.
Keywords
Temporomandibular Disorders, Electromyogram,, Modalities of physiotherapy,, Temporomandibular dysfunction syndrome,, Lasers.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phototherapy
Arm Type
Experimental
Arm 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) .
Arm Title
Placebo phototherapy
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Radiation
Intervention Name(s)
Phototherapy
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
Placebo phototherapy
Intervention Description
The volunteers will be subjected to the same Groups ' intervention and placebo pen Phototherapy.
Primary Outcome Measure Information:
Title
Pain intensity.
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Electromyographic activity
Description
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.
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Analysis of superficial cutaneous temperature
Description
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.
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniela Ap Biasotto-Gonzalez, Doctor
Organizational Affiliation
University of Nove de Julho
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nove de Julho
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
01415000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela Ap Biasotto-Gonzalez, Doctor
Phone
+5511999063166
Email
dani_atm@ig.com.br

12. IPD Sharing Statement

Citations:
PubMed Identifier
28602137
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.
Results Reference
derived
PubMed Identifier
25514875
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.
Results Reference
derived
Links:
URL
http://www.uninove.br
Description
URL of the University of Nove de Julho

Learn more about this trial

Effect of Phototherapy in Individuals With Temporomandibular Disorder.

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