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- Ensayo clínico NCT03556423
Neurophysiological Mechanisms Involved in Knee Osteoarthritis
26 de mayo de 2022 actualizado por: Guillaume Léonard, Université de Sherbrooke
Pain in Individuals With Knee Osteoarthritis : Beyond the Joint and the Musculoskeletal System
Introduction: Total knee arthroplasty (TKA) is an effective intervention to relieve people with osteoarthritis (OA).
Nevertheless, 15 to 30% of patients continue to experience severe pain following surgery.
Recent data suggest that central nervous system (CNS) changes may play a role in OA pain and possibly explain why some patients have poorer clinical outcomes following TKA.
Objectives: Our main objectives are to explore the relationship between OA pain and (1) the integrity of corticospinal system, (2) the efficacy of descending pain inhibition circuits.
Methods: Fifty-two patients waiting for TKA will be recruited.
The integrity of the corticospinal projections will be measured using transcranial magnetic stimulation (recruitment curve of the affected quadriceps femoris muscle) and the descending pain inhibition circuits (bulbospinal projections) will be assessed by a counter-irritation paradigm (i.e., conditioned pain modulation with immersion of the arm in painfully cold water).
Diffuse tension imaging (DTI) will also be used to quantify the strength of these corticospinal and bulbospinal projections.
Clinical outcomes will be evaluated before and after arthroplasty with a series of validated questionnaires such as the WOMAC Scale, the McGill Pain Questionnaire and the Brief Pain Inventory.
These different neurophysiological and clinical measures will be taken before surgery, 6 months after surgery and 1 year post-surgery.
Anticipated results: The investigators expect a moderate association between pain and the strength of the corticospinal and bulbospinal projections.
Moreover, it is expected that there will be a moderate association between the strength of the corticospinal/bulbospinal projections and the clinical evolution of patients.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
See outcome measures
Tipo de estudio
De observación
Inscripción (Actual)
28
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Quebec
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Sherbrooke, Quebec, Canadá, J1H 4C4
- Centre de recherche sur le vieillissement (CdRV)
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Sherbrooke, Quebec, Canadá, J1H 5N4
- CRCHUS: Centre de recherche du centre hospitalier universitaire de Sherbrooke
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
50 años a 79 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Adults aged 50-79 years old with a diagnosis of knee OA and waiting for a primary arthroplasty
Descripción
Inclusion Criteria:
- Being an adults aged 50-79 years old with a diagnosis of knee OA and waiting for a primary arthroplasty
- Refrain from consuming cigarettes and caffeine 2 hours and 6 hours before testing, respectively
- Refrain from taking short-acting analgesics (e.g., acetaminophen) 6 hours before testing
Exclusion Criteria:
- Having difficulty understanding french language
- Having a diagnosis of neurological disorder or diagnosis of chronic pain (other knee OA)
- Having metal implants in the skull
- Having pacemaker or neurostimulator
- Being pregnant
- Being epileptic
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Change from baseline - Integrity of the corticospinal system
Periodo de tiempo: Before surgery, 6 months and 1 year post-surgery
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This outcome will be measured by transcranial magnetic stimulation (TMS)
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Before surgery, 6 months and 1 year post-surgery
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Change from baseline - Descending pain inhibition circuits
Periodo de tiempo: Before surgery, 6 months and 1 year post-surgery
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This outcome will be measured by a counter-irritation paradigm (conditioned pain modulation using a thermode and a bath of circulating cold water)
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Before surgery, 6 months and 1 year post-surgery
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Change from baseline - Pain intensity
Periodo de tiempo: Before surgery, 6 months and 1 year post-surgery
|
This outcome will be measured by a visual analogue scale (VAS).
The VAS is a straight horizontal line of fixed length, usually 10 cm.
The ends are defined as the extreme limits of the parameter to be measured; 0 = "no pain", 10 = "the worst imaginable pain".
Using a ruler, the score is determined by measuring the distance (cm) on the 10 cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-10.
A higher score indicates greater pain intensity.
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Before surgery, 6 months and 1 year post-surgery
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Change from baseline - Pain, stiffness and physical function
Periodo de tiempo: Before surgery, 6 months and 1 year post-surgery
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This outcome will be measured by Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
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Before surgery, 6 months and 1 year post-surgery
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Pain catastrophizing
Periodo de tiempo: Before surgery, 6 months and 1 year post-surgery
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This outcome will be measured with the Pain Catastrophizing Scale (PCS) .
The PCS inquire participants to reflect on past painful experiences, and to indicate the degree to which they experienced each of 13 thoughts or feelings when experiencing pain.
Each item of the PCS is scored on a 5-point scale where 0 = not at all and 4 = all the time.
PCS yields three subscale scores assessing rumination, magnification and helplessness.
The PCS total score is computed by summing responses to all 13 items.
The PCS yields a total score ranging from 0 to 52.
Higher values on this scale represent a greater tendency of the subject to perceive pain negatively and to foresee the consequences of pain in a more catastrophic way.
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Before surgery, 6 months and 1 year post-surgery
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Kinesiophobia
Periodo de tiempo: Before surgery, 6 months and 1 year post-surgery
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This outcome will be measured with the Tampa Scale of Kinesiophobia (TSK) .
The TSK is a 17-item self-report checklist using a 4-point Likert scale that was developed as a measure of fear of movement or (re)injury.
The total score ranges between 17 and 68.
A high value on the TSK indicates a high degree of kinesiophobia, and a cutoff score was developed by Vlaeyen (1995), where a score of 37 or over is considered as a high score, while scores below that are considered as low scores.
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Before surgery, 6 months and 1 year post-surgery
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Anxiety
Periodo de tiempo: Before surgery, 6 months and 1 year post-surgery
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This outcome will be measured with the Spielberger's State-Trait Anxiety Inventory
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Before surgery, 6 months and 1 year post-surgery
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Qualitative aspect of pain
Periodo de tiempo: Before surgery, 6 months and 1 year post-surgery
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This outcome will be measured by the McGill Pain Questionnaire
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Before surgery, 6 months and 1 year post-surgery
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Impact of pain on physical function and quality of life
Periodo de tiempo: Before surgery, 6 months and 1 year post-surgery
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This outcome will be measured by the Brief Pain Inventory (BPI)
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Before surgery, 6 months and 1 year post-surgery
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Functional autonomy, social autonomy
Periodo de tiempo: Before surgery, 6 months and 1 year post-surgery
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This outcome will be measured by the SMAF questionnaire
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Before surgery, 6 months and 1 year post-surgery
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Level of physical activity
Periodo de tiempo: Before surgery, 6 months and 1 year post-surgery
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Physical Activity Scale for the Elderly (PASE)
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Before surgery, 6 months and 1 year post-surgery
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Hypersensitivity of central nervous system
Periodo de tiempo: Before surgery, 6 months and 1 year post-surgery
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This outcome will be measured by the Central Sensitization Inventory
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Before surgery, 6 months and 1 year post-surgery
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Guillaume Leonard, Ph.D., pht., Centre de recherche sur le vieillissement (CdRV)
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de julio de 2018
Finalización primaria (Actual)
1 de mayo de 2020
Finalización del estudio (Actual)
1 de marzo de 2022
Fechas de registro del estudio
Enviado por primera vez
16 de mayo de 2018
Primero enviado que cumplió con los criterios de control de calidad
12 de junio de 2018
Publicado por primera vez (Actual)
14 de junio de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de mayo de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
26 de mayo de 2022
Última verificación
1 de mayo de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2015-454-IUGS
Plan de datos de participantes individuales (IPD)
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INDECISO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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