Efecto de las férulas nocturnas y de tiempo completo para el síndrome del túnel carpiano (FINCROSS)
Efecto de las férulas nocturnas y de tiempo completo para el síndrome del túnel carpiano: un ensayo de superioridad cruzado aleatorizado, multicéntrico, de tres períodos (FINCROSS - Ensayo finlandés cruzado para el síndrome del túnel carpiano)
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.).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Vieda Lusa
- Número de teléfono: +358408713465
- Correo electrónico: fincross.trial@gmail.com
Ubicaciones de estudio
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-
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Helsinki, Finlandia
- Reclutamiento
- Terveystalo Kamppi
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Contacto:
- Teemu Paatela
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Jyväskylä, Finlandia
- Reclutamiento
- Hospital Nova of Central Finland
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Contacto:
- Teemu Karjalainen
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Jyväskylä, Finlandia
- Reclutamiento
- Terveystalo Jyväskylä
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Contacto:
- Teemu Karjalainen
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Mikkeli, Finlandia
- Reclutamiento
- Mikkeli Central Hospital
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Contacto:
- Anniina Laurema
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Tampere, Finlandia
- Activo, no reclutando
- Tampere University Hospital
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Tampere, Finlandia
- Reclutamiento
- Terveystalo Tampere
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Contacto:
- Teemu Karjalainen
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- 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),
- Symptom duration of CTS for at least 3 weeks,
- No previous corticosteroid injection for CTS during last 6 months,
- No previous surgery for CTS,
- Aged 18 years or older,
- Able to complete self-report questionnaires electronically,
- Able to understand Finnish,
- Willing to join the study and follow the study protocol instructions,
- Sign informed consent.
Exclusion Criteria:
- Nerve root or plexus disorders that might be causing CTS mimicking symptoms (e.g., cervical radiculopathy, thoracic outlet syndrome, or whiplash associated disorders),
- Other neurological condition affecting the function of the hand such as Multiple Sclerosis, previous nerve injury,
- Active Rheumatoid arthritis or any other active inflammatory joint disease affecting the hand,
- Thenar muscle atrophy,
- Untreated hypothyroidism,
- Known allergy to any of the splint materials (self-reported by patient),
- Long term treatment (over 4 months) for CTS with no response,
- Any other known reason that could prevent from participation for the study time.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: 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. |
neutral-positioned wrist orthosis |
|
Otro: 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. |
neutral-positioned wrist orthosis |
|
Otro: 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. |
neutral-positioned wrist orthosis |
|
Otro: 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. |
neutral-positioned wrist orthosis |
|
Otro: 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. |
neutral-positioned wrist orthosis |
|
Otro: 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. |
neutral-positioned wrist orthosis |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change of The 6-item CTS Symptoms Scale scores between baseline and 6 weeks
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change of The 6-item CTS Symptoms Scale scores between baseline and 3 weeks
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 1 year
|
Finnish version of EQ-5D-5L will be used. |
1 year
|
|
Adverse effects
Periodo de tiempo: up to 1 year
|
Assessed by participant self-reported adverse events. |
up to 1 year
|
|
Need for surgery
Periodo de tiempo: 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)
Periodo de tiempo: 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
Patrocinador
Investigadores
- Investigador principal: Teemu Karjalainen, Tampere University Hospital
- Investigador principal: Jarkko Jokihaara, Tampere University Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Nervioso
- Heridas y Lesiones
- Enfermedades Neuromusculares
- Enfermedades del Sistema Nervioso Periférico
- Neuropatía mediana
- Mononeuropatías
- Síndromes de compresión nerviosa
- Trastornos Traumáticos Acumulativos
- Torceduras y esguinces
- Síndrome del túnel carpiano
- Fijadores externos
- Dispositivos de fijación ortopédica
- Equipo ortopédico
- Equipo quirúrgico
- Equipos y suministros
- Dispositivos de fijación quirúrgica
- Férulas
Otros números de identificación del estudio
- R22093
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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