Public trial
RBR-8vny3v Combined use of body movements with laser light for the stimulation of nerves and muscles on the face
Date of registration: 07/27/2020 (mm/dd/yyyy)Last approval date : 07/27/2020 (mm/dd/yyyy)
Study type:
Interventional
Scientific title:
en
Different Kinesiotherapies associated with Biophotonics for Neuro-facial muscular Reprograming
pt-br
Diferentes Cinesioterapias associadas á Biofotônica para reprogramação Neuro-muscular Facial
Trial identification
- UTN code: U1111-1252-4644
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Public title:
en
Combined use of body movements with laser light for the stimulation of nerves and muscles on the face
pt-br
Uso combinado de movimentos corporais com a luz laser para estimulação dos nervos e músculos da face
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Scientific acronym:
en
ILIB
pt-br
ILIB
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Public acronym:
en
ILIB
pt-br
ILIB
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Secondaries identifiers:
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45390715.2.0000.5419
Issuing authority: Plataforma Brasil
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1.125.894
Issuing authority: Comitê de Ética da Faculdade de Odontologia de Ribeirão Preto da Universidade de São Paulo
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1.519.380
Issuing authority: Faculdade de Odontologia de Ribeirão Preto
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45390715.2.0000.5419
Sponsors
- Primary sponsor: University of São Paulo, São Carlos Physics Institute, Department of Optics and Biophotonics
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Secondary sponsor:
- Institution: University of São Paulo, São Carlos Physics Institute, Department of Optics and Biophotonics
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Supporting source:
- Institution: University of São Paulo, São Carlos Physics Institute, Department of Optics and Biophotonics
Health conditions
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Health conditions:
en
Arterial Blood Pressure, glucose and cholesterol
pt-br
Pressão Arterial, glucose e colesterol
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General descriptors for health conditions:
en
C23 Pathological conditions, signs and symptoms
pt-br
C23 Condições patológicas, sinais e sintomas
es
C23 Condiciones patológicas, signos y síntomas
en
I00-I99 IX - Diseases of the circulatory system
pt-br
I00-I99 IX - Doenças do aparelho circulatório
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Specific descriptors:
Interventions
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Interventions:
en
Groups 1-6 were composed of 6 women each with ages ranging between 35 and 55 years of age, without the presence of systemic (hypertension and diabetes) or heart diseases. All interventions occurred within 60 days. G1 (negative control)= Patients received placebo laser treatments (2x per week). G2 (experimental)= Patients received transcutaneous low intensity laser therapy (30 min, 2x per week) treatments delivered at the radial artery by one diode laser (660nm, 100 mW/cm2) G3 (experimental)= Patients received transcutaneous low intensity laser therapy (30 min, 2X per week) treatments delivered at radial artery by two diode laser (660 nm, 50 mW/cm2 each diode) G4 (experimental)= Patients received transmucosal low intensity laser therapy (30 mim, 2x per week) treatments delivered at the sublingual region by one diode laser (660 nm, 100 mW/cm2). G5 (experimental)= Patients received transmucosal low intensity laser therapy (30 min, 2x per week) treatments delivered at the intranasal region by one diode laser (660 nm, 100 mW/cm2). G6 (experimental)= Patients received 2 transcutaneous low intensity laser therapy (30 min, 3x per week) treatments. Each treatment lasted for 10 consecutive day. Treatments were separated by a 20-day interval. Treatment were delivered at the radial artery by one diode laser (660nm, 100 mW/cm2)
pt-br
Grupos 1-6 foram compostos por 6 mulheres com idades entre 35 e 55 anos de idade, sem histórico de doenças sistêmicas (hipertensão e diabetes) ou do coração. Todas as intervenções ocorreram dentro de um prazo de 60 dias G1 (controle negativo)= Pacientes receberam tratamento placebo (2x por semana) de laser terapia. G2 (experimental)= Pacientes receberam tratamento transcutâneo de laser terapia de baixa intensidade (30 min, 2x por semana) entregue na região da artéria radial por um diodo laser (660 nm, 100 mW/cm2). G3 (experimental)= Pacientes receberam tratamento transcutâneo de laser terapia de baixa intensidade (30 min, 2x por semana) entregue na região da artéria radial por dois diodos laser (660 nm, 50 mW/cm2 cada diodo). G4 (experimental)= Pacientes receberam tratamento transmucoso de laser terapia de baixa intensidade (30 min, 2x por semana) entregue na região sublingual por um diodo laser (660 nm, 100 mW/cm2). G5 (experimental)= Pacientes receberam tratamento transmucoso de laser terapia de baixa intensidade (30 min, 2x por semana) entregue na região intranasal por um diodo laser (660 nm, 100 mW/cm2). G6 (experimental)= Pacientes receberam 2 tratamentos transcutâneos de laser terapia de baixa intensidade (30 min, 2x por semana). Cada tratamento durou 10 dias consecutivos e houve um intervalo de 20 dias entre tratamentos. Os tratamentos foram entregues na região da artéria radial por um diodo laser (660 nm, 100 mW/cm2)
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Descriptors:
en
E07.632.490 Lasers
pt-br
E07.632.490 Lasers
es
E07.632.490 Rayos Láser
en
E02.594 Laser Therapy
pt-br
E02.594 Terapia a Laser
es
E02.594 Terapia por Láser
en
E02.594.540 Low-Level Light Therapy
pt-br
E02.594.540 Terapia com Luz de Baixa Intensidade
es
E02.594.540 Terapia por Luz de Baja Intensidad
Recruitment
- Study status: Recruitment completed
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Countries
- Brazil
- Date first enrollment: 03/05/2018 (mm/dd/yyyy)
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Target sample size: Gender: Minimum age: Maximum age: 50 F 35 Y 55 Y -
Inclusion criteria:
en
Healthy females; ages between 35 and 55 years; no history of systemic diseases such as hypertension, diabetes or heart diseases
pt-br
Mulheres sadias; idades entre 35 e 55 anos; sem histórico de condições sistêmicas como hipertensão, diabetes ou doenças cardíacas
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Exclusion criteria:
en
Presence of uncontrolled systemic diseases; pregnant women; breast feeding women; presence of oral tumors; presence of temporomandibular joint disorder.
pt-br
Presença de doenças sistêmicas não controladas; mulheres grávidas; mulheres lactantes; presença de tumores orais; presença de disfunção temporo-mandíbular
Study type
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Study design:
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Expanded access program Purpose Intervention assignment Number of arms Masking type Allocation Study phase Treatment Parallel 5 Single-blind Randomized-controlled N/A
Outcomes
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Primary outcomes:
en
It is expect to verify the effect of low intensity level laser irradiation on the modulation of arterial blood pressure (systolic and diastolic) and glucose and cholesterol levels in blood, as determined by blood exams and the present of statistically significant differences (p<0.05)
pt-br
Espera-se verificar o efeito da laser terapia de baixa intensidade na modulação da pressão arterial (sistólica e diastólica) e dos níveis sanguíneos de glucose e colesterol, verificados por meio de exame de sangue e constatação de diferenças estatisticamente significativas (p<0.05)
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Secondary outcomes:
en
Secondary outcomes are not expected
pt-br
Não são esperados desfechos secundários
Contacts
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Public contact
- Full name: Rosane de Fátima Zanirato Lizarelli
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- Address: Av. Trabalhador São Carlense, 400
- City: São Carlos / Brazil
- Zip code: 13560-970
- Phone: +55 16 98820-6448
- Email: Lizarelli@hotmail.com
- Affiliation: University of São Paulo, São Carlos Physics Institute, Department of Optics and Biophotonics
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Scientific contact
- Full name: Rosane de Fátima Zanirato Lizarelli
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- Address: Av. Trabalhador São Carlense, 400
- City: São Carlos / Brazil
- Zip code: 13560-970
- Phone: +55 16 98820-6448
- Email: Lizarelli@hotmail.com
- Affiliation: University of São Paulo, São Carlos Physics Institute, Department of Optics and Biophotonics
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Site contact
- Full name: Rosane de Fátima Zanirato Lizarelli
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- Address: Av. Trabalhador São Carlense, 400
- City: São Carlos / Brazil
- Zip code: 13560-970
- Phone: +55 16 98820-6448
- Email: Lizarelli@hotmail.com
- Affiliation: University of São Paulo, São Carlos Physics Institute, Department of Optics and Biophotonics
Additional links:
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