Neurophysiological Mechanisms Involved in Knee Osteoarthritis
26 de maio de 2022 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
See outcome measures
Tipo de estudo
Observacional
Inscrição (Real)
28
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.
Locais de estudo
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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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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
50 anos a 79 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
Adults aged 50-79 years old with a diagnosis of knee OA and waiting for a primary arthroplasty
Descrição
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
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
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from baseline - Integrity of the corticospinal system
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Pain catastrophizing
Prazo: Before surgery, 6 months and 1 year post-surgery
|
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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Level of physical activity
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Guillaume Leonard, Ph.D., pht., Centre de recherche sur le vieillissement (CdRV)
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)
1 de julho de 2018
Conclusão Primária (Real)
1 de maio de 2020
Conclusão do estudo (Real)
1 de março de 2022
Datas de inscrição no estudo
Enviado pela primeira vez
16 de maio de 2018
Enviado pela primeira vez que atendeu aos critérios de CQ
12 de junho de 2018
Primeira postagem (Real)
14 de junho de 2018
Atualizações de registro de estudo
Última Atualização Postada (Real)
27 de maio de 2022
Última atualização enviada que atendeu aos critérios de controle de qualidade
26 de maio de 2022
Última verificação
1 de maio de 2022
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2015-454-IUGS
Plano para dados de participantes individuais (IPD)
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INDECISO
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