RBR-4hb9qs Efficacy of Auriculotherapy in treatment of chronic pain caused by Chikungunya

Date of registration: 04/22/2020 ^(mm/dd/yyyy)
Last approval date : 04/22/2020 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: B96250895353

• Public title:

  en

  Efficacy of Auriculotherapy in treatment of chronic pain caused by Chikungunya

  pt-br

  Eficácia da Auriculoterapia no tratamento das dores crônicas causadas pela Chikungunya

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • Número do CAAE:81597417.0.0000.5037
    Issuing authority: Plataforma Brasil
  • Número do Parecer do CEP: 2.496.372
    Issuing authority: Comitê de Ética em Pesquisa da Escola de Saúde Pública do Ceará

Sponsors

• Primary sponsor: Fundação Oswaldo Cruz
• Secondary sponsor:
  • Institution: Fundação Oswaldo Cruz
• Supporting source:
  • Institution: Fundação Oswaldo Cruz

Health conditions

• Health conditions:

  en

  Chikungunya

  pt-br

  Chikungunya

• General descriptors for health conditions:

  en

  C02 Virus diseases

  pt-br

  C02 Viroses

  es

  C02 Virosis

• Specific descriptors:

Interventions

• Interventions:

  en

  Experimental group: auriculotherapy, once a week, with mustard seeds and adhesive tape in points with analgesic effect in 55 patients with Chikungunya for six weeks Control group: placing adhesive tape on points with analgesic effect, once a week, in 55 patients, for six weeks

  pt-br

  Grupo experimental: auriculoterapia, uma vez por semana, com sementes de mostarda e fita adesiva em pontos com efeito analgésico em 55 pacientes com Chikungunya durante seis semanas Grupo controle: colocação de fita adesiva em pontos com efeito analgésico, uma vez por semana, em 55 pacientes, durante seis semanas

• Descriptors:

  en

  E02.190.204 Auriculotherapy

  pt-br

  E02.190.204 Auriculoterapia

  es

  E02.190.204 Auriculoterapia

Recruitment

• Study status: Data analysis completed
• Countries
  • Brazil
• Date first enrollment: 03/01/2018 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  110	-	18 Y	80 Y

• Inclusion criteria:

  en

  have a clinical and / or laboratory diagnosis of chikungunya; having been in pain for at least three months; be aged between 18 and 80 years; having preserved cognitive functions

  pt-br

  ter diagnóstico clínico e/ou laboratorial de chikungunya; estar há pelo menos três meses sentindo dores; ter idade entre 18 e 80 anos; estar com as funções cognitivas preservadas

• Exclusion criteria:

  en

  having a previous cancer diagnosis; being on immunosuppressive drugs; have been hospitalized up to 30 days before the start of auriculotherapy sessions

  pt-br

  possuir diagnóstico prévio de câncer; estar em uso de medicamentos imunossupressor; ter sido internado até 30 dias antes do início das sessões de auriculoterapia

Study type

• Study design:

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

Outcomes

• Primary outcomes:

  en

  It is expected to find analgesia, using the Visual Analog Scale for Pain, from the finding of a score below 5 in the pre and post-intervention measurements

  pt-br

  Espera-se encontrar analgesia, utilizando a Escala Visual Analógica para Dor, a partir da constatação de escore abaixo de 5 nas medições pré e pós-intervenção

• Secondary outcomes:

  en

  It is expected to find analgesia, using the Visual Analog Scale for Pain, based on the verification of a score below 7 after 50% of the intervention was performed

  pt-br

  Espera-se encontrar analgesia, utilizando a Escala Visual Analógica para Dor, a partir da constatação de escore abaixo de 7 após realização de 50% da intervenção

Contacts

• Public contact
  • Full name: Márcio Flávio Moura de Araújo
  • • Address: Rua São José, S/N
    • City: Eusébio / Brazil
    • Zip code: 61760-000
  • Phone: +55-085-32156450
  • Email: oicam29@gmail.com
  • Affiliation: Fundação Oswaldo Cruz
   
• Scientific contact
  • Full name: Márcio Flávio Moura de Araújo
  • • Address: Rua São José, S/N
    • City: Eusébio / Brazil
    • Zip code: 61760-000
  • Phone: +55-085-32156450
  • Email: oicam29@gmail.com
  • Affiliation: Fundação Oswaldo Cruz
   
• Site contact
  • Full name: Márcio Flávio Moura de Araújo
  • • Address: Rua São José, S/N
    • City: Eusébio / Brazil
    • Zip code: 61760-000
  • Phone: +55-085-32156450
  • Email: oicam29@gmail.com
  • Affiliation: Fundação Oswaldo Cruz
   

Additional links:

• Download in ICTRP format