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Public trial
 

                                        

                    

                        

                            

                            

                        

                        

                            

                                
RBR-399cyrr Therapeutic proposal for treatment of hip Tendinopathies


                                Date of registration:
                                
                                    06/02/2021                                    (mm/dd/yyyy)
                                
                                

                                Last approval date :
                                
                                    06/02/2021                                    (mm/dd/yyyy)
                                
                                
Study type:


                                
Interventional


                                
 


                                
 


                                
Scientific title:


                                

                                                                        

                                        
en

                                        
Therapeutic proposal for treatment of hip Tendinopathies

                                        

                                        
pt-br

                                        
Proposta terapêutica de tratamento para as Tendinopatias do quadril

                                        
                                


                                
 



                                
Trial identification

                                
    
                                    
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                                        UTN code: 
                                        U1111-1259-7308
                                    
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    Public title:
    
                                        
    
                                                                                        
    
                                                    
    en
    
                                                    
    Therapeutic proposal for treatment of hip Tendinopathies
    
                                                
    
                                                    
    pt-br
    
                                                    
    Proposta de tratamento para as Tendinites do quadril
    
                                                
                                            
    
                                    
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    Scientific acronym:
    
                                        
    
                                                                                                                                
    
                                    
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    Public acronym:
    
                                        
    
                                                                                                                                
    
                                    
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                                        Secondaries identifiers:
                                                                                                                            
      
                                                
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                                                    3.736.265
      
                                                    Issuing authority:
                                                    Comité de Ética em Pesquisa - UniCEUB 
                                                
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                                                    19585819.0.0000.0023
      
                                                    Issuing authority:
                                                    Plataforma Brasil
                                                
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Sponsors

                                
    
                                    
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                                        Primary sponsor:
                                        Centro Universitário de Brasília - UniCEUB
                                    
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                                        Secondary sponsor:
                                                                                                                                                                                                            
      
                                                
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                                                    Institution:
                                                    Hospital Ortopédico de Medicina Especializada
                                                
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                                        Supporting source:
                                                                                                                            
      
                                                
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                                                    Institution:
                                                    Hospital Ortopédico de Medicina Especializada
                                                
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Health conditions

                                
    
                                    
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    Health conditions:
    
                                        
    
                                                                                        
    
                                                
    en
    
                                                
    tendinopathy; hip injuries
    
                                                
    
                                                
    pt-br
    
                                                
    tendinopatia; lesões do quadril
    
                                                
                                            
    
                                    
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    General descriptors for health conditions:
    
                                        
    
                                                
    en
    
                                                
    
                                                    C05
                                                    Musculoskeletal Diseases
                                                
    
                                                
    
                                                
    pt-br
    
                                                
    
                                                    C05
                                                    Doenças Musculoesqueléticas
                                                
    
                                                
                                                                                    
     
    
                                    
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    Specific descriptors:
    
                                        
    
                                                
    en
    
                                                
    
                                                    C05.651.869
                                                    tendinopathy
                                                
    
                                                
    
                                                
    pt-br
    
                                                
    
                                                    C05.651.869
                                                    Tendinopatia
                                                
    
                                                
    
                                                
    en
    
                                                
    
                                                    C26.531
                                                    Hip Injuries
                                                
    
                                                
    
                                                
    pt-br
    
                                                
    
                                                    C26.531
                                                    Lesões do Quadril
                                                
    
                                                
                                            
     
    
                                    
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Interventions

                                
    








                                    
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    Interventions:
    
                                        
    
                                                                                        
    
                                                
    en
    
                                                
    Experimental Group: 40 adults diagnosed with gluteal tendinopathy will receive an exercise program of 8 weeks and 16 sessions, with gradually progressive traction load in minimal hip adduction positions with different modes of strength training, including isometric, isotonic, concentric and eccentric , for the muscles of the hip, abdominal core and lower limbs.
Control group: 40 adults diagnosed with gluteal tendinopathy will receive an exercise program of 8 weeks and 16 sessions, with gradually progressive traction load in minimal hip adduction positions with different modes of strength training, including isometric, isotonic, concentric and eccentric , for the hip muscles.
    
                                                
    
                                                
    pt-br
    
                                                
    Grupo experimental: 40 adultos diagnosticados com tendinopatia glútea receberão um programa de exercícios de 8 semanas e 16 sessões, com carga de tração gradualmente progressiva em posições de adução de quadril mínima com modos diferentes de treinamento de força, incluindo isométrico, isotônico, concêntrico e excêntrico, para os músculos do quadril, núcleo abdominal e membros inferiores.
Grupo controle: 40 adultos diagnosticados com tendinopatia glútea receberão um programa de exercícios de 8 semanas e 16 sessões, com carga de tração gradualmente progressiva em posições de adução de quadril mínima com modos diferentes de treinamento de força, incluindo isométrico, isotônico, concêntrico e excêntrico, para os músculos do quadril.
    
                                                
                                            
    
                                    
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    Descriptors:
    
                                        
    
                                                    
    en
    
                                                    
    
                                                        E02.760.169.063.500.387
                                                        Exercise Therapy
                                                    
    
                                                    
    
                                                    
    pt-br
    
                                                    
    
                                                        E02.760.169.063.500.387
                                                        Exercício Terapêutico
                                                    
    
                                                    
                                            
     
    
                                    
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Recruitment

                                
    
                                    
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                                        Study status:
                                                                                Recruiting
                                    
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                                        Countries
                                        
      
                                            
    • Brazil
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                                        Date first enrollment:
                                        
                                                                                        02/20/2021                                            (mm/dd/yyyy)
                                        

                                    
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                                                Target sample size:
                                                Gender:
                                                Minimum age:
                                                Maximum age:
                                            
    
                                            
    
                                                80
                                                -
                                                18 Y
                                                100 Y
                                            
    
                                            
    
                                    
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    Inclusion criteria:
    
                                        
    
                                                                                        
    
                                                
    en
    
                                                
    Adults diagnosed with gluteal tendinopathy through clinical and magnetic resonance imaging and who had persistent pain in the lateral region of the hip above 3 on the analogue pain scale (VAS) for more than 3 months will be admitted to the study
    
                                                
    
                                                
    pt-br
    
                                                
    Voluntários adultos; ambos os gêneros; sem limite superior de idade; diagnosticados com tendinopatia glútea através do exame clínico e de ressonância magnética; dor na região lateral do quadril acima de 3 na escala analógica de dor; há mais de 3 meses
    
                                                
                                            
    
                                    
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    Exclusion criteria:
    
                                        
    
                                                                                        
    
                                                
    en
    
                                                
    Patients diagnosed with joint pathologies such as coxarthrosis, avascular osteonecrosis of the femoral head, pain from spinal disorders or any arthropathy detected on radiographic examination were excluded from the study.
    
                                                
    
                                                
    pt-br
    
                                                
    Voluntários diagnosticados com patologias articulares do quadril, como coxartrose; osteonecrose avascular da cabeça femoral; dor proveniente de afecções da coluna; artropatia detectada em exame radiográfico. 
    
                                                
                                            
    
                                    
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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
                                                2
                                                Open
                                                Randomized-controlled
                                                N/A
                                            
    
                                                
                                        
    
                                    
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Outcomes

                                
    
                                    
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    Primary outcomes:
    
                                        
    
                                                    
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                                                        Evaluation of pain reduction verified by visual analogue pain scale and measured by pressure algometer.

                                                    
    
                                                    
    
                                                    
    pt-br
    
                                                    
    
                                                        Avaliar a diminuição da dor mensurada pela escala visual analógica de dor e medida pelo algômetro de pressão.


                                                    
    
                                                    
    
                                                    
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                                                        Evaluation of improvement in hip function measured by the Harris Hip Score and Hip Outcome Score questionnaires.
                                                    
    
                                                    
    
                                                    
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                                                        Avaliar a melhora da Função do quadril mensurada pelos questionários Harris Hip Score e Hip Outcome Score.
                                                    
    
                                                    
                                            
     
    
                                    
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    Secondary outcomes:
    
                                        
    
                                                
    en
    
                                                
    
                                                    Strength improvement, verified by e-last 02863-17-10410, portable, bluetooth dynamometer (Technology BR 10201400007232-2).

                                                
    
                                                
    
                                                
    pt-br
    
                                                
    
                                                    Avaliar a melhora da força, verificado por dinamômetro manual e-last 02863-17-10410, portátil, bluetooth (Tecnologia BR 10201400007232-2).  


                                                
    
                                                
    
                                                
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                                                    Increased range of motion verified using a universal goniometer.
                                                
    
                                                
    
                                                
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                                                    Aumento da amplitude de movimento verificado através de um goniômetro universal.
                                                
    
                                                
                                            
     
    
                                    
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Contacts

                                
    

                                    
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                                        Public contact

                                        
      
                                                                                            
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                                                    Full name:
                                                    Tatiane  Morelati Rosa
                                                
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                                                            Address:
                                                            SEPN, 707/907 Campus Universitário, Asa Norte
                                                        
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                                                            City: 
                                                            Brasília / Brazil
                                                        
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                                                            Zip code:
                                                            70790-075
                                                        
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                                                    Phone:
                                                    +55-61-991625545
                                                
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                                        Scientific contact

                                        
      
                                                                                            
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                                                    Full name:
                                                    Tatiane  Morelati Rosa
                                                
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                                                            Address:
                                                            SEPN, 707/907 Campus Universitário, Asa Norte
                                                        
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                                                            City:
                                                            Brasília / Brazil
                                                        
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                                                            Zip code:
                                                            70790-075
                                                        
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                                                    Phone:
                                                    +55-61-991625545
                                                
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                                                    Full name:
                                                    Tatiane  Morelati Rosa
                                                
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                                                            Address:
                                                            SEPN, 707/907 Campus Universitário, Asa Norte
                                                        
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                                                            City:
                                                            Brasília / Brazil
                                                        
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                                                            Zip code:
                                                            70790-075
                                                        
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                                                    +55-61-991625545
                                                
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Total de Ensaios Clínicos 16963.



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Existem 4701 ensaios clínicos recrutando.



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