RBR-29bt5qt Acupuncture treatment of people with residual symptoms of COVID-19 infection

Date of registration: 02/15/2022 ^(mm/dd/yyyy)
Last approval date : 02/15/2022 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1274-4824

• Public title:

  en

  Acupuncture treatment of people with residual symptoms of COVID-19 infection

  pt-br

  Tratamento com acupuntura de pessoas com sintomas residuais da infecção por COVID-19

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 48405321.1.0000.5442
    Issuing authority: Plataforma Brasil
  • 4.854.418
    Issuing authority: Comitê de Ética em Pesquisa do Hospital do Servidor Público Municipal (HSPM)

Sponsors

• Primary sponsor: Hospital do Servidor Público Municipal
• Secondary sponsor:
  • Institution: Hospital do Servidor Público Municipal
• Supporting source:
  • Institution: Hospital do Servidor Público Municipal

Health conditions

• Health conditions:

  en

  Sequelae of other specified infectious and parasitic diseases

  pt-br

  Seqüelas de outras doenças infecciosas e parasitárias especificadas

• General descriptors for health conditions:

  en

  B34.2 Coronavirus infection of unspecified location

  pt-br

  B34.2 Infecção por coronavírus de localização não especificada

• Specific descriptors:

  en

  B94.8 Sequelae of other specified infectious and parasitic diseases

  pt-br

  B94.8 Seqüelas de outras doenças infecciosas e parasitárias especificadas

Interventions

• Interventions:

  en

  Intervention group: 50 patients with sequelae of COVID-19 will be treated with acupuncture in 10 weekly sessions of 20 minutes each session. Quality of life questionnaires, Edmonton scale to assess symptoms and Lanns pain scale will be applied when there is pain in the first, fifth and tenth sessions. No control group.

  pt-br

  Grupo intervenção: 50 pacientes com sequelas de COVID-19 serão tratados com acupuntura em 10 sessões semanais de 20 minutos de duração cada sessão. Serão aplicados questionários de qualidade de vida, escala de Edmonton para avaliar os sintomas e escala de dor de Lanns quando houver dor na primeira, quinta e décima sessões. Sem grupo controle.

• Descriptors:

  en

  E02.190.044 Acupuncture Therapy

  pt-br

  E02.190.044 Terapia por Acupuntura

Recruitment

• Study status: Recruitment completed
• Countries
  • Brazil
• Date first enrollment: 07/19/2021 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  50	-	0	0

• Inclusion criteria:

  en

  Patients with sequelae of COVID-19 who agree to sign the free and informed consent form.

  pt-br

  Pacientes com sequelas do COVID-19 que aceitarem assinar o termo de consentimento livre e esclarecido.

• Exclusion criteria:

  en

  Patients with severe psychiatric problems, with surgical indication, with serious illnesses that require emergency care or with acute coronavirus disease

  pt-br

  Pacientes com problemas psiquiátricos graves, com indicação cirúrgica, com doenças graves que necessitem de atendimento emergencial ou com doença aguda pelo coronavírus

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  	Treatment	Single-group	1	Open	Single-arm-study	N/A

Outcomes

• Primary outcomes:

  en

  Acupuncture is expected to ameliorate the persistent symptoms presented by coronavirus infection observed by the Edmonton scale.

  pt-br

  Espera-se que a acupuntura melhore os sintomas persistentes apresentados pela infecção do coronavírus observados pela escala de Edmonton.

• Secondary outcomes:

  en

  Acupuncture is expected to improve quality of life by evaluating the results of the quality of life questionnaire.

  pt-br

  Espera-se que a acupuntura melhore a qualidade de vida por meio de avaliação dos resultados do questionário de qualidade de vida.

Contacts

• Public contact
  • Full name: Luciana Aikawa
  • • Address: Rua Castro Alves, 60
    • City: São Paulo / Brazil
    • Zip code: 01532-000
  • Phone: +55(11)33977867
  • Email: luaikawa@gmail.com
  • Affiliation: Hospital do Servidor Público Municipal
   
• Scientific contact
  • Full name: Luciana Aikawa
  • • Address: Rua Castro Alves, 60
    • City: São Paulo / Brazil
    • Zip code: 01532-000
  • Phone: +55(11)33977867
  • Email: luaikawa@gmail.com
  • Affiliation: Hospital do Servidor Público Municipal
   
• Site contact
  • Full name: Luciana Aikawa
  • • Address: Rua Castro Alves, 60
    • City: São Paulo / Brazil
    • Zip code: 01532-000
  • Phone: +55(11)33977867
  • Email: luaikawa@gmail.com
  • Affiliation: Hospital do Servidor Público Municipal
   

Additional links:

• Download in ICTRP format