RBR-6mkndk Evaluation of the analgesic effect of Pregabalin for joint pain after Chikungunya.

Date of registration: 11/11/2020 ^(mm/dd/yyyy)
Last approval date : 11/11/2020 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1253-8114

• Public title:

  en

  Evaluation of the analgesic effect of Pregabalin for joint pain after Chikungunya.

  pt-br

  Avaliação do efeito analgésico da Pregabalina para dor articular após Chikungunya.

• Scientific acronym:

  pt-br

  ERAPT

• Public acronym:

  pt-br

  ERAPT

• Secondaries identifiers:
  • CAAE: 34247020.6.0000.5505
    Issuing authority: Plataforma Brasil
  • Número de parecer:4.288.101
    Issuing authority: Comitê de Ética em Pesquisa da Universidade Federal de São Paulo - UNIFESP/EPM

Sponsors

• Primary sponsor: Rodrigo Souza Rodrigues
• Secondary sponsor:
  • Institution: Rodrigo Souza Rodrigues
• Supporting source:
  • Institution: Universidade Federal de São Paulo - UNIFESP/EPM

Health conditions

• Health conditions:

  en

  Joint pain;Chikungunya

  pt-br

  Dor articular;Chikungunya

• General descriptors for health conditions:

  en

  A92.0

  pt-br

  A92.0 Chikungunya

  en

  M25.5

  pt-br

  M25.5 Dor articular

• Specific descriptors:

Interventions

• Interventions:

  en

  Groups Participants will be allocated in two groups. Group 1 - 18 patients You will be submitted to treatment with the association of hydroxychloroquine (400mg, 1 tablet/day for 3 months) with pregabaline (75mg, 1 cp/d for 5 days, and then 1 cp/12h for 3 months). Concomitant Group 2 - 17 patients You will be treated with hydroxychloroquine (400mg, 1 tablet/day for 3 m). You will be reevaluated with 2sem, 1m, 2m, 3m. Complementary analgesic The analgesic complementation will be done with dipyrone 1g (until every 4 hours). If there is no pain relief, patients can use tramadol 50mg (1 tablet up to 400mg /day). Evaluation The evaluation will be with: - Pain intensity by the numerical verbal scale from 0 to 10, before the beginning of the drug and after 2sem, 1m, 2m and 3m. - Questionnaire for quality of life of the patient WHOQOL-100 questionnaire (attached), before the beginning of the drugs, 2 weeks, 1m, 2m and 3m after the use of the drugs - Dose of complementary analgesics - Adverse effects will be noted

  pt-br

  Grupos Os participantes serão alocados em dois grupos. Grupo 1 - 18 pacientes Será submetido ao tratamento com associação da hidroxicloroquina (400mg, 1 comprimido/ dia durante 3 meses) com a pregabalina (75mg, 1 cp/ d durante 5 dias, e posteriormente 1 cp/12h, durante 3 meses). Concomitante Grupo 2 - 17 pacientes Será submetido ao tratamento com hidroxicloroquina (400mg, 1 comprimido/ dia durante 3 m). Serão reavaliados com 2sem, 1m, 2m, 3m. Analgésico complementar A complementação analgésica será feita com dipirona 1g (até a cada 4 horas). Não havendo alívio da dor, os pacientes poderão utilizar tramadol 50mg (1 comprimido até 400mg /dia). Avaliação A avaliação será com: • Intensidade da dor pela escala numérica verbal de 0 a 10, antes do início do medicamento e após 2sem, 1m, 2m e 3m. • Questionário para qualidade de vida do paciente questionário WHOQOL-100 (anexo), antes do início dos medicamentos, 2 semanas, 1m, 2m e 3m após o uso das medicações • Dose de analgésicos complementares • Efeitos adversos serão anotados

• Descriptors:

  en

  E03.091

  pt-br

  E03.091 Analgesia

Recruitment

• Study status: Not yet recruiting
• Countries
  • Brazil
• Date first enrollment: 02/01/2021 ^(mm/dd/yyyy)
• Date last enrollment: 04/01/2021 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  35	-	18 Y	100 Y

• Inclusion criteria:

  en

  35 participants will be included aged 18 to 100 years old; Both sexes; With chronic illness (more than 3 months); Individuals with arthralgia after chikungunya, previously diagnosed with sorology positive for CHIK; Individuals with pain upper than 4

  pt-br

  Serão incluídos 35 participantes com idade de 18 a 100anos; Ambos os sexos; Com doença crônica (mais de 3 meses); Indivíduos com quadro de artralgia após chikungunya, diagnosticados previamente com sorologia positiva para CHIK e Indivíduos com dor maior que 4

• Exclusion criteria:

  en

  Non-inclusion criteria patient with sorologies for CHIK with negative IGG and positive IGM; FR (rheumatoid factor) and FAN (antinuclear factor) positive in high values; Cognitive dysfunction (unable to understand the explanations); Psychiatric illness; Drug user; Pregnancy

  pt-br

  Serão excluídos os pacientes com Sorologias para CHIK com IGG negativo e IGM positivo; FR (fator reumatóide) e FAN (fator antinuclear) positivos em altos valores; Disfunção cognitiva (sem condições de entender as explicações); Doença psiquiátrica; Usuário de drogas; Grávidas

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  	Treatment	Parallel	2	Open	Randomized-controlled	1-2

Outcomes

• Primary outcomes:

  en

  The present study aims to assess the decrease in pain intensity with the use of pregabalin associated with hydroxychloroquine, compared with hydroxychloroquine alone for patients with chikungunya. Pain assessment will be on the verbal numeric scale from 0 to 10, before the start of the medication and after 2weeks, 1m, 2m and 3m.

  pt-br

  O presente estudo tem como objetivo avaliar a diminuição da intensidade da dor com uso da pregabalina associada com a hidroxicloroquina, comparando com a hidroxicloroquina isolada para pacientes com chikungunya. A avaliação da dor será pela escala numérica verbal de 0 a 10, antes do início do medicamento e após 2sem, 1m, 2m e 3m.

• Secondary outcomes:

  en

  An improvement in quality of life is expected due to improved pain scores both in the control group and in the intervention group, but with greater intensity in the intervention group, which will be assessed through the WHOQOL-100 questionnaire which will be applied at the beginning and at the end of the study

  pt-br

  Espera-se uma melhora da qualidade de vida devido melhora dos escores de dor tanto no grupo controle quanto no grupo intervenção porém com maior intensidade no grupo intervenção o qual será avaliado através do questionário WHOQOL-100 o qual será aplicado no início e no final do estudo

  en

  Assess the occurrence of side effects of the studied drugs and supplemental analgesics

  pt-br

  Avaliar a ocorrência de efeitos colaterais do medicamentos estudados e dos analgésico suplementares

Contacts

• Public contact
  • Full name: Rodrigo Souza Rodrigues
  • • Address: rua gama quadra 7, lote 13, sn, casa
    • City: AÇAILÂNDIA / Brazil
    • Zip code: 65930-000
  • Phone: +55-99-991222285
  • Email: rodrigo_fameca@hotmail.com
  • Affiliation: Rodrigo Souza Rodrigues
   
• Scientific contact
  • Full name: Rodrigo Souza Rodrigues
  • • Address: Rua Gama qd 7, lote 13, sn, casa
    • City: acailandia / Brazil
    • Zip code: 65930-000
  • Phone: +55-99-991222285
  • Email: rodrigo_fameca@hotmail.com
  • Affiliation: Rodrigo Souza Rodrigues
   
• Site contact
  • Full name: Rodrigo Souza Rodrigues
  • • Address: Rua Gama qd 7, lote 13, sn, casa
    • City: acailandia / Brazil
    • Zip code: 65930-000
  • Phone: +55-99-991222285
  • Email: rodrigo_fameca@hotmail.com
  • Affiliation: Rodrigo Souza Rodrigues
   

Additional links:

• Download in ICTRP format