- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07699289
Diagnostic Value of Digital Infrared Thermographic Imaging in Diagnosing Carpal Tunnel Syndrome
The goal of this observational study is to evaluate skin temperature patterns measured by infrared thermography in patients with carpal tunnel syndrome (CTS). The main questions it aims to answer are: Are skin temperature patterns associated with CTS as determined by 6-item CTS scale?
Participants diagnosed with CTS as part of their routine clinical care will undergo infrared thermal imaging and electrodiagnostic evaluation according to the study protocol. The relationship between thermographic findings and electrodiagnostic severity will be analyzed.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Methods
Submit the study protocol for approval by the Human Research Ethics Committee of Ramathibodi Hospital.
Recruit eligible participants, including both cases and controls, who meet the predefined inclusion and exclusion criteria.
Explain the study objectives and procedures to all potential participants. Written informed consent will be obtained from all participants before enrollment.
Digital infrared thermography of both hands will be performed according to the following standardized procedure:
- Participants will be asked whether they have received any physical therapy or physical modality to the index hand within the preceding 24 hours. If so, the thermographic examination will be rescheduled for the next visit whenever possible; otherwise, the participant may be excluded.
- Participants will be asked whether they have applied any oil, cream, powder, deodorant, or antiperspirant to their hands. If present, these substances will be removed by washing before image acquisition.
- Participants will remain in the examination room with both hands dry, uncovered, and resting at room temperature for at least 15 minutes to allow thermal equilibration.
- Infrared thermographic images of the index hand will be obtained with the hand positioned perpendicular to the detector at a fixed distance sufficient to include all fingers and the wrist within the image.
- For participants undergoing electrodiagnostic evaluation as part of routine clinical care, thermography will be performed before the electrodiagnostic study.
A physician will perform history taking, physical examination, and assessment using the CTS-6 scale. The following information will be collected:
- Age
- Sex
- Comorbidities
- Duration of symptoms (months)
- Side of the affected hand
- CTS-6 score (<12 or ≥12)
- Autonomic symptoms, including edema, dry skin, skin pallor, sweating asymmetry, skin temperature asymmetry, and Raynaud's phenomenon
- Small-fiber sensory assessment, including pinprick sensation and cold sensation screening using a cold metal instrument
Skin temperature will be measured from thermographic images at the first, second, and third fingertips, the thenar eminence, and the hypothenar eminence. Thermographic parameters will subsequently be calculated according to the method described by Park et al.
Electrodiagnostic findings of the index hand will be retrieved from medical records if the examination was performed as part of routine clinical care. The following information will be collected:
- Final electrodiagnostic interpretation (normal, carpal tunnel syndrome, or other neuropathies)
- Key electrodiagnostic findings supporting the interpretation (e.g., median distal sensory peak latency and median distal motor latency)
Electrodiagnostic findings will not be used to determine participant eligibility or establish the diagnosis. Diagnostic accuracy analyses will be performed using the CTS-6 as the primary reference standard.
Statistical analyses will be performed to determine the diagnostic performance of infrared thermography.
Study findings will be analyzed and reported.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Apisara Keesukphan
- Número de teléfono: 6622011154
- Correo electrónico: apisara.kee@mahidol.ac.th
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- 18 years old or more
- Were referred to the department of rehabilitation for electrodiagnostic evaluation of the disease not involved in the index hand
- The hand of interest has cumulative score of less than 12 from CTS-6 scale
Exclusion Criteria:
- History of hand surgery in the index hand
- Having a condition which may alter surface temperature of the hand, for example, infection, scar in the interested area, arthritis, other peripheral neuropathy, uncontrolled diabetes mellitus, uncontrolled thyroid disease, stroke, and vascular disease
- Having hand deformities that render collecting DITI information to calculate the parameters of interest impossible, for example, amputation of any part of the hand
- Current medication affecting sympathetic tone
- Severe tremors or inability to maintain standardized positioning
- Electrodiagnosis result other than normal or carpal tunnel syndrome in the hand of interest
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
|
Carpal tunnel syndrome
patient with suspected CTS
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Diagnostic value
Periodo de tiempo: at the Enrollment
|
Diagnostic value of Digital Infrared Thermographic in diagnosis of CTS
|
at the Enrollment
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MURA2026/366
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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