RBR-4d3kvz5 Effectiveness of Genicular Block image guided with Phenol for the treatment of Chronic Pain due to Knee Ostheoarthritis

Date of registration: 12/06/2022 ^(mm/dd/yyyy)
Last approval date : 12/06/2022 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1285-7166

• Public title:

  en

  Effectiveness of Genicular Block image guided with Phenol for the treatment of Chronic Pain due to Knee Ostheoarthritis

  pt-br

  Eficácia do bloqueio de Nervos Geniculares guiado por imagem com Fenol para o tratamento de dor crônica devido Osteoartrite de Joelho

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 45253321.0.1001.5505
    Issuing authority: Plataforma Brasil
  • 4.894.046
    Issuing authority: Comitê de Ética em Pesquisa da Universidade Federal de São Paulo

Sponsors

• Primary sponsor: Universidade Federal de São Paulo
• Secondary sponsor:
  • Institution: Universidade Federal de São Paulo
• Supporting source:
  • Institution: Universidade Federal de São Paulo

Health conditions

• Health conditions:

  en

  Knee Ostheoarthritis

  pt-br

  Osteoartrite de Joelho

• General descriptors for health conditions:

  en

  C05.550.114.606 Ostheoarthritis

  pt-br

  C05.550.114.606 Osteoartrite

• Specific descriptors:

  en

  C05.550.114.606.500 Knee Ostheoarthritis

  pt-br

  C05.550.114.606.500 Osteoartrite de Joelho

Interventions

• Interventions:

  en

  All patients will undergo a diagnostic block with 3.0 mL of 0.25% bupivacaine in the superolateral and superomedial quadrants and 1.0 mL in the inferior medial and inferolateral quadrants. Patients who experienced pain relief ≥ 50% will be randomized into two groups: chemical neurolysis (CN) or intra-articular corticosteroid (IC). Patients will be followed up for six months and evaluated for pain score at rest and movement, functional assessment with timed and ir test and sit-to-stand test, and quality of life using knee injury and outcome. Osteoarthritis Score (KOOS) or WOMAC

  pt-br

  Todos os pacientes serão submetidos a um bloqueio diagnóstico com 3,0mL de bupivacaína 0,25% no quadrante superolateral e superomedial e 1,0 mL no quadrante medial inferior e inferolateral. Os pacientes que apresentaram alívio da dor ≥ 50% serão randomizados em dois grupos: neurólise química (NC) ou corticosteroide intra-articular (CI). Os pacientes serão acompanhados por seis meses e avaliados quanto ao escore de dor em repouso e movimento, avaliação funcional com teste cronometrado e ir (TUG) e teste sentar-se de pé (STS), e qualidade de vida usando lesão no joelho e resultado de osteoartrite Pontuação (KOOS) ou WOMAC.

• Descriptors:

  en

  E03.155.086.711 Neurolisis

  pt-br

  E03.155.086.711 Neurolise

Recruitment

• Study status: Recruiting
• Countries
  • Brazil
• Date first enrollment: 12/01/2022 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  80	-	18 Y	0

• Inclusion criteria:

  en

  Severe knee pain with pain greater than 6 on the numerical rating scale ; Knee osteoarthritis Kellgren-Lawrence classification 2 to 4, uni or bilateral; More than six months without improvement with conservative treatment

  pt-br

  Dor forte no joelho com dor maior que 6 pela escala de avaliação numérica; Osteoartrite do joelho classificação de Kellgren-Lawrence 2 a 4, uni ou bilateral; Há mais de seis meses sem melhora com o tratamento conservador

• Exclusion criteria:

  en

  Patients with cognitive impairment ; Psychiatric illnesses; Other causes of knee pain (trauma, complex regional pain syndrome, rheumatoid arthritis or lumbosciatalgia or sciatica); Puncture site infection; Coagulopathy; Anticoagulant use; Body Mass Index >40kg/m2; Previous Total Knee Arthroplasty

  pt-br

  Pacientes com comprometimento cognitivo; Pacientes com doenças psiquiátricas; Pacientes com outras causas de dor no joelho(trauma, síndrome de dor regional complexa de membro, artrite reumatóide ou lombociatalgia ou ciatalgia); Infecção no local de punção; Coagulopatia; Uso de anticoagulante; Indice de Massa Corporal> 40 kg/m2; Artroplastia Total de Joelho anterior

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

  Reduction of pain intensity of 50% or more for 6 months, on the numerical rating scale

  pt-br

  Redução da intensidade da dor em 50% ou mais por 6 meses, pela escala de avaliação numérica

• Secondary outcomes:

  en

  Improvement of Knee Function evaluated by Knee injury and Osteoarthritis Outcome Score(KOOS) or Western Ontario and McMaster Universities Arthritis Index(WOMAC)

  pt-br

  Melhora da função do joelho avaliado pelo KOOS (Knee injury and Osteoarthritis Outcome Score) ou WOMAC (Western Ontario and McMaster Universities Arthritis Index).

  en

  Improvement of quality of life evaluated by Knee injury and Osteoarthritis Outcome Score(KOOS) or Western Ontario and McMaster Universities Arthritis Index(WOMAC)

  pt-br

  Melhora da qualidade de vida avaliado pelo KOOS (Knee injury and Osteoarthritis Outcome Score) ou WOMAC (Western Ontario and McMaster Universities Arthritis Index).

Contacts

• Public contact
  • Full name: Kelson Koiti Ogata
  • • Address: Rua Botucatu, 821 8 andar
    • City: São Paulo / Brazil
    • Zip code: 04023-062
  • Phone: +55 015 98187-1727
  • Email: kelson.ogata@hotmail.com
  • Affiliation: Universidade Federal de São Paulo
   
• Scientific contact
  • Full name: Rioko Kimiko Sakata
  • • Address: Rua Botucatu, 821 8 andar
    • City: São Paulo / Brazil
    • Zip code: 04023-062
  • Phone: +55 011 99914-9177
  • Email: rsakata@unifesp.br
  • Affiliation: Universidade Federal de São Paulo
   
• Site contact
  • Full name: Leonardo da Cunha Ferraro
  • • Address: Rua Botucatu, 821 8 andar
    • City: São Paulo / Brazil
    • Zip code: 04023-062
  • Phone: +55 011 99951-6103
  • Email: leohcferraro1@hotmail.com
  • Affiliation: Universidade Federal de São Paulo
   

Additional links:

• Download in ICTRP format