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Efeito da tala noturna e em tempo integral para a síndrome do túnel do carpo (FINCROSS)

29 de setembro de 2026 atualizado por: Tampere University Hospital

Efeito da tala noturna e em período integral para a síndrome do túnel do carpo: um estudo multicêntrico, de três períodos, randomizado e cruzado de superioridade (FINCROSS - Estudo finlandês cruzado para a síndrome do túnel do carpo)

Carpal tunnel syndrome is a common compression neuropathy of upper extremities. Its usual symptoms are pain, numbness and tingling of fingers, which tend to be worse at night. Splinting the wrist with an external orthosis is usually a first-line treatment provided to most people with mild to moderate disease.

The FINCROSS trial (randomized cross-over trial) aims to assess the effect of night-time and full-time splinting in comparison with no-treatment. It also aims to identify possible subgroups of people who would benefit from splinting, as well as assess if positive response to splinting is associated with subsequent lower need of surgery.

The trial will recruit 110 people with carpal tunnel syndrome in Finland. Each participant will undergo all three treatment periods in a randomised order: 1) splinting at night-time for six weeks, 2) splinting both day and night for six weeks; and 3) be assessed under a six weeks long control period of no-treatment.

Each treatment period will be separated with a three-week washout period. Therefore, the whole treatment sequence for each participant lasts 24 weeks after randomization. The participant will be followed-up to 1 year after the randomisation.

Additionally, the participants will get instructions for self-administered stretching exercises to perform throughout the study. All participants will be asked to avoid any intervention administered or supervised by medical personnel (such as structured supervised exercises, manual therapy, steroid injections, surgery, etc.).

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

110

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Finlândia
      • Helsinki, Finlândia
        • Recrutamento
        • Terveystalo Kamppi
        • Contato:
          • Teemu Paatela
      • Jyväskylä, Finlândia
        • Recrutamento
        • Hospital Nova of Central Finland
        • Contato:
          • Teemu Karjalainen
      • Jyväskylä, Finlândia
        • Recrutamento
        • Terveystalo Jyväskylä
        • Contato:
          • Teemu Karjalainen
      • Mikkeli, Finlândia
        • Recrutamento
        • Mikkeli Central Hospital
        • Contato:
          • Anniina Laurema
      • Tampere, Finlândia
        • Ativo, não recrutando
        • Tampere University Hospital
      • Tampere, Finlândia
        • Recrutamento
        • Terveystalo Tampere
        • Contato:
          • Teemu Karjalainen

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  1. Clinically confirmed carpal tunnel syndrome (CTS) of any severity level (diagnostic criteria: numbness, pain or paraesthesia in the median nerve distribution area of wrist and fingers),
  2. Symptom duration of CTS for at least 3 weeks,
  3. No previous corticosteroid injection for CTS during last 6 months,
  4. No previous surgery for CTS,
  5. Aged 18 years or older,
  6. Able to complete self-report questionnaires electronically,
  7. Able to understand Finnish,
  8. Willing to join the study and follow the study protocol instructions,
  9. Sign informed consent.

Exclusion Criteria:

  1. Nerve root or plexus disorders that might be causing CTS mimicking symptoms (e.g., cervical radiculopathy, thoracic outlet syndrome, or whiplash associated disorders),
  2. Other neurological condition affecting the function of the hand such as Multiple Sclerosis, previous nerve injury,
  3. Active Rheumatoid arthritis or any other active inflammatory joint disease affecting the hand,
  4. Thenar muscle atrophy,
  5. Untreated hypothyroidism,
  6. Known allergy to any of the splint materials (self-reported by patient),
  7. Long term treatment (over 4 months) for CTS with no response,
  8. Any other known reason that could prevent from participation for the study time.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição cruzada
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Outro: Sequence of three treatment periods in the following order: ABC

Splinting at night while sleeping for 6 weeks (period A), then no treatment for 6 weeks (period B), then splinting at day and night for 6 weeks (period C). Each treatment period will be separated by 3-week washout period.
Dispositivo: splinting

neutral-positioned wrist orthosis
Outro: Sequence of three treatment periods in the following order: ACB

Splinting at night while sleeping for 6 weeks (period A), then splinting at day and night for 6 weeks (period C), then no treatment for 6 weeks (period B). Each treatment period will be separated by 3-week washout period.
Dispositivo: splinting

neutral-positioned wrist orthosis
Outro: Sequence of three treatment periods in the following order: BAC

No treatment for 6 weeks (period B), then splinting at night while sleeping for 6 weeks (period A), then splinting at day and night for 6 weeks (period C). Each treatment period will be separated by 3-week washout period.
Dispositivo: splinting

neutral-positioned wrist orthosis
Outro: Sequence of three treatment periods in the following order: BCA

No treatment for 6 weeks (period B), then splinting at day and night for 6 weeks (period C), then splinting at night while sleeping for 6 weeks (period A). Each treatment period will be separated by 3-week washout period.
Dispositivo: splinting

neutral-positioned wrist orthosis
Outro: Sequence of three treatment periods in the following order: CAB

Splinting at day and night for 6 weeks (period C), then splinting at night while sleeping for 6 weeks (period A), then no treatment for 6 weeks (period B). Each treatment period will be separated by 3-week washout period.
Dispositivo: splinting

neutral-positioned wrist orthosis
Outro: Sequence of three interventions/treatments in the following order: CBA

Splinting at day and night for 6 weeks (period C), then no treatment for 6 weeks (period B), then splinting at night while sleeping for 6 weeks (period A). Each treatment period will be separated by 3-week washout period.
Dispositivo: splinting

neutral-positioned wrist orthosis

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change of The 6-item CTS Symptoms Scale scores between baseline and 6 weeks
Prazo: 6 weeks, i.e. end of each treatment period

6-item CTS Symptoms Scale is a 6-item questionnaire, with score from 1 to 5 to each of the item, higher score indicating worse symptoms. The study will use a Finnish version of The 6-item CTS Symptoms Scale.
6 weeks, i.e. end of each treatment period

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change of The 6-item CTS Symptoms Scale scores between baseline and 3 weeks
Prazo: 3 weeks, i.e. middle of each treatment period

6-item CTS Symptoms Scale is a 6-item questionnaire, with score from 1 to 5 to each of the item, higher score indicating worse symptoms. The study will use a Finnish version of The 6-item CTS Symptoms Scale.
3 weeks, i.e. middle of each treatment period
Change of The 6-item CTS Symptoms Scale scores between baseline and 1 year
Prazo: 1 year

6-item CTS Symptoms Scale is a 6-item questionnaire, with score from 1 to 5 to each of the item, higher score indicating worse symptoms. The study will use a Finnish version of The 6-item CTS Symptoms Scale.
1 year
Change of The Boston Carpal Tunnel Questionnaire Symptom Severity Scale scores (BCTQ SSS) between baseline and 6 weeks of each treatment period
Prazo: 6 weeks, i.e. end of each treatment period

BCTQ SSS is an 11-item questionnaire, with score from 1 to 5 to each of the item, higher score indicating worse symptoms. The study will use a Finnish version of the BCTQ SSS.
6 weeks, i.e. end of each treatment period
Change of The Boston Carpal Tunnel Questionnaire Symptom Severity Scale scores (BCTQ SSS) between baseline and 1 year
Prazo: 1 year

BCTQ SSS is an 11-item questionnaire, with score from 1 to 5 to each of the item, higher score indicating worse symptoms. The study will use a Finnish version of the BCTQ SSS.
1 year
Change of The Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ FSS) between baseline and 6 weeks of each treatment period
Prazo: 6 weeks, i.e. end of each treatment period

BCTQ FSS is an 8-item questionnaire, with score from 1 to 5 to each of the item, higher score indicating worse function. The study will use a Finnish version of the BCTQ FSS.
6 weeks, i.e. end of each treatment period
Change of The Boston Carpal Tunnel Questionnaire Functional Status Scale (BCTQ FSS) between baseline and 1 year
Prazo: 1 year

BCTQ FSS is an 8-item questionnaire, with score from 1 to 5 to each of the item, higher score indicating worse function. The study will use a Finnish version of the BCTQ FSS.
1 year
Change of The Boston Carpal Tunnel Questionnaire (BCTQ) Total between baseline and 6 weeks
Prazo: 6 weeks, i.e. end of each treatment period

BCTQ Total consists of BCTQ SSS and BCTQ FSS, with score from 1 to 5 to each of the item, higher score indicating worse function.
6 weeks, i.e. end of each treatment period
Change of The Boston Carpal Tunnel Questionnaire (BCTQ) Total between baseline and 1 year
Prazo: 1 year

BCTQ Total consists of BCTQ SSS and BCTQ FSS, with score from 1 to 5 to each of the item, higher score indicating worse function.
1 year
Overall improvement as measured by 7-point Likert Scale
Prazo: 6 weeks, i.e. end of each treatment period

7-point Likert Scale assesses the improvement of hand symptoms with 7 possible scores: much better, better, somewhat better, no changes, somewhat worse, worse, much worse.
6 weeks, i.e. end of each treatment period
Overall improvement as measured by 7-point Likert Scale
Prazo: 1 year

7-point Likert Scale assesses the improvement of hand symptoms with 7 possible scores: much better, better, somewhat better, no changes, somewhat worse, worse, much worse.
1 year
Change of The EuroQol 5-dimension (EQ-5D-5L) Health Status and Quality-of-life Measure score between baseline and 6 weeks of each treatment period
Prazo: 6 weeks, i.e. end of each treatment period

Finnish version of EQ-5D-5L will be used.
6 weeks, i.e. end of each treatment period
Change of The EuroQol 5-dimension (EQ-5D-5L) Health Status and Quality-of-life Measure score between baseline and 1 year
Prazo: 1 year

Finnish version of EQ-5D-5L will be used.
1 year
Adverse effects
Prazo: up to 1 year

Assessed by participant self-reported adverse events.
up to 1 year
Need for surgery
Prazo: up to 1 year

Assessed by participant self-reported information of referral to or executed surgery.
up to 1 year
Escape treatments (e.g., corticosteroid injection or any other treatment supervised by medical personnel)
Prazo: up to 1 year

Assessed by participant self-reported information of undergoing or having undergone the escape treatment.
up to 1 year

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Tampere University Hospital

Colaboradores

Mikkeli Central Hospital
Terveystalo
Hospital Nova, Central Finland

Investigadores

  • Investigador principal: Teemu Karjalainen, Tampere University Hospital
  • Investigador principal: Jarkko Jokihaara, Tampere University Hospital

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

15 de fevereiro de 2023

Conclusão Primária (Estimado)

1 de dezembro de 2028

Conclusão do estudo (Estimado)

1 de dezembro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

18 de outubro de 2022

Enviado pela primeira vez que atendeu aos critérios de CQ

23 de novembro de 2022

Primeira postagem (Real)

5 de dezembro de 2022

Atualizações de registro de estudo

Última Atualização Postada (Real)

5 de outubro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

29 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • R22093

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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