Dor Neuropática Crónica Grave: Um Pacote de Tratamento, Utilizando Estimulação da Medula Espinal e Tratamento Multidisciplinar, para Reduzir a Dor e Melhorar a Função Física. (SCS-R)
Otimização do Tratamento para Dor Neuropática Crónica: Um Desenho Experimental de Caso Único Replicado que Avalia um Pacote de Tratamento Consistente em Reabilitação Multidisciplinar e Estimulação da Medula Espinhal (SCS-R)
Pessoas com danos nos nervos podem desenvolver dor nervosa. A dor pode por vezes ser severa e imprevisível, causando sensações estranhas ou alarmantes - por exemplo, sensações semelhantes a relâmpagos ou choques elétricos na área servida pelo nervo danificado.
Vamos examinar um tratamento para a dor nervosa nas pernas causada por danos nos nervos, que pode ocorrer após uma hérnia discal ou uma fratura óssea, com ou sem cirurgia.
Investigação anterior sugere que a estimulação da medula espinhal pode aliviar a dor nervosa nas pernas após cirurgia ou lesão, mas a sua eficácia ainda é debatida. Outros estudos mostram que o tratamento multidisciplinar ajuda pessoas com dor de longa duração a melhorar a sua qualidade de vida e a lidar melhor com a vida. Diretrizes nacionais e internacionais recomendam este tipo de cuidados multidisciplinares para dor de longa duração.
Ninguém publicou ainda investigação sobre estimulação da medula espinhal combinada com tratamento multidisciplinar como uma intervenção em pacote. Por isso, queremos descobrir se esta abordagem combinada pode reduzir a dor nervosa nas pernas e melhorar o funcionamento físico.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Single-case experimental design (SCED) with repeated measurements structured into phases is the method of this study.
Phase A1 is the pre-implantation baseline, Phase A2 is waiting time from implantation to start of the intervention (SCS+rehabilitation). Length of A2 is randomized (2-4 weeks).
Phase B is the active SCS+rehabilitation intervention and lasts for 12 weeks (for analysis split into an early B1 (week 1-5) and a later B2 period (week 8-12), and FU is the 5 week follow-up approximately 6 months after implantation.
Outcomes are measured repeatedly within these phases, allowing within-patient phase contrasts.
In general, baseline (A1) is compared with the intervention periods (B1 and B2) and with follow-up (FU). The main pre-specified contrasts for the primary outcomes are:
- For leg pain intensity A1 vs B1 is the primary comparison and A1 vs B2 is secondary, with A1 vs FU and B2 vs FU reported descriptively.
- For physical function (PROMIS-29), A1 vs B2 is the primary comparison as onset of rehabilitation effect is expected to be delayed. A1 vs B1 is exploratory, with A1 vs FU and B2 vs FU reported descriptively.
Other repeated-measures outcomes (PROMIS-29 domains and additional NRS/physical activity measures) follow the same structure, with A1 vs B2 generally defined as secondary and A1 vs FU descriptive as shown in the statistical tables
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Christopher Ekholdt, PhD-student
- Número de telefone: +4723026161
- E-mail: chrekh@ous-hf.no
Estude backup de contato
- Nome: Lars-Petter Granan, Ph.D
- Número de telefone: +4723026161
- E-mail: largra@ous-hf.no
Locais de estudo
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Oslo, Noruega
- Recrutamento
- Department of pain management and research, Oslo university hospital
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Contato:
- Lars-Petter Granan, Ph.D
- Número de telefone: +4723026161
- E-mail: largra@ous-hf.no
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Contato:
- Christopher Ekholdt, Ph.D-student
- Número de telefone: +4723026161
- E-mail: chrekh@ous-hf.no
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
Critérios de inclusão:
Dor neuropática periférica em uma ou ambas as pernas durante >6 meses devido a:
- (1) Síndrome de Dor Pós-Espinal (tipo 1 ou 2).
- (2) Lesão nervosa localizada.
- A área da dor neuropática na(s) perna(s) deve ser o componente de dor dominante.
- Idades compreendidas entre os 18 e os 60 anos.
- Tentativa prévia de tratamento conservador padrão (ou cirúrgico).
- Uso de opioides dentro dos limites permitidos no momento do implante (dose diária de opioides <50 mg OMEQ).
- Disposição para participar ativamente no pacote de tratamento.
- Residir a uma distância razoável de viagem de Oslo.
- Proficiência na compreensão do norueguês oral e escrito, essencial para beneficiar do programa que depende de compreensão mútua, conversa matizada e expressão emocional, que são dependentes da língua.
- Capacidade cognitiva para dar consentimento informado.
- Capacidade para dominar os aspetos técnicos do sistema SCS (mudar programas no comando remoto).
Critérios de exclusão:
- Atualmente a passar pelo processo de reclamação de benefícios de saúde (por exemplo, pensões de invalidez do NAV (Administração do Trabalho e Bem-Estar da Noruega).
- Apresentar um distúrbio psicológico ou psiquiátrico que possa afetar a eficácia do tratamento.
- Condições de dor crónica generalizada.
- Outras condições de dor na área afetada, como osteoartrite.
- Gravidez.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Pacote de tratamento
Pacote de tratamento consistindo em estimulação da medula espinhal mais reabilitação multidisciplinar
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A intervenção é um pacote de tratamento que consiste em estimulação da medula espinhal mais reabilitação multidisciplinar.
A reabilitação multidisciplinar consiste em terapia de exercício, terapia cognitiva e programação individualizada do dispositivo SCS.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Pain intensity in leg(s)
Prazo: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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Assessed using an 11-point Numeric Rating Scale (NRS 0-10) for leg pain the last 24 hours, where 0 = "no pain" and 10 = "worst imaginable pain." Higher scores indicate more severe pain. MCID: decrease of ≥2 points. Measured three times per week during the single-case experimental design phases: baseline (A1), SCS+rehabilitation intervention (B1/B2), and follow-up (FU) . |
From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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Physical function (PROMIS-29)
Prazo: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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Assessed using the PROMIS-29 Physical Function domain T-score (mean 50, SD 10 in the reference population).
Higher scores indicate better physical function.
MCID: increase of ≥5 T-score points.
Measured three times per week during the single-case experimental design phases: baseline (A1), SCS+rehabilitation intervention (B1/B2), and follow-up (FU) .
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From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Pain intensity in the lower back
Prazo: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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Assessed using an 11-point Numeric Rating Scale (NRS 0-10) for lower back pain the last 24 hours, where 0 = "no pain" and 10 = "worst imaginable pain." Higher scores indicate more severe pain. MCID: decrease of ≥2 points. Measured three times per week during the single-case experimental design phases: baseline (A1), SCS+rehabilitation intervention (B1/B2), and follow-up (FU) |
From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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Pain interference (PROMIS-29)
Prazo: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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Assessed using the PROMIS-29 Pain Interference domain T-score. Higher scores indicate more interference of pain with daily activities. Improvement is defined as a decrease of ≥5 T-score points (MCID). Assessed once a week at baseline (A1), during SCS+rehabilitation (B1/B2), and at follow-up (FU). |
From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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Pain intensity (PROMIS-29)
Prazo: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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Assessed using an 11-point Numeric Rating Scale (NRS 0-10) for pain intensity last 7 days in PROMIS-29, where 0 = "no pain" and 10 = "worst imaginable pain." Higher scores indicate more severe pain. MCID: decrease of ≥2 points. Assessed at baseline (A1), during SCS+rehabilitation (B1/B2), and at follow-up (FU). |
From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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Physical function (6-min-walk test)
Prazo: Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
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Functional walking capacity is assessed using the Six-Minute Walk Test (6MWT). Distance walked in 6 minutes on a flat course is recorded in meters; higher distances indicate better walking capacity. Assessed pre-implantation, end of SCS+rehabilitation (end of B2), and at follow-up (FU). |
Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
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Physical function (sit-to-stand test)
Prazo: Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
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Lower limb functional strength and endurance are assessed with a Sit-to-Stand Test, recorded as number of repetitions in a fixed time.
More repetitions indicate better performance.
Assessed pre-implantation, end of SCS+rehabilitation (end of B2), and at follow-up (FU).
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Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
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Physical function (stair test)
Prazo: Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
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Functional mobility is assessed using a Stair test (ST; time to climb 18 stairs 3 times; lower times indicate better function). Assessed pre-implantation, end of SCS+rehabilitation (end of B2), and at follow-up (FU). |
Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
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Physical activity (MET-minutes per week)
Prazo: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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Physical activity is assessed as metabolic equivalent (MET) minutes per week, calculated from reported frequency and duration of activities (International Physical Activity Questionnaire (IPAQ)). Higher values indicate greater weekly physical activity. Assessed once per week during baseline (A1), SCS+rehabilitation (B1/B2), and follow-up (FU) within the single-case experimental design. |
From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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Health-related quality of life (EQ-5D index)
Prazo: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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EQ-5D-5L index score (range 0-1; higher scores indicate better health-related quality of life). Assessed once a week at baseline (A1), during SCS+rehabilitation (B1/B2), and at follow-up (FU). |
From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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Health-related quality of life (EQ-5D-5L VAS)
Prazo: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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EQ-5D Visual Analogue Scale (EQ-5D VAS; 0-100; higher scores indicate better health-related quality of life). Assessed once a week at baseline (A1), during SCS+rehabilitation (B1/B2), and at follow-up (FU). |
From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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Depression symptoms (PROMIS-29)
Prazo: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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PROMIS Depression scale (T-score; mean 50, SD 10 in U.S. population; higher scores indicate greater symptom severity).
Improvement is defined as a decrease of ≥5 T-score points (MCID).
Assessed once a week at baseline (A1), during SCS+rehabilitation (B1/B2), and at follow-up (FU).
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From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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Social participation (PROMIS-29)
Prazo: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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PROMIS Ability to Participate in Social Roles and Activities short form, reported as a T-score (higher scores indicate better function). MCID: increase of ≥5 T-score points. Assessed once a week at baseline (A1), during SCS+rehabilitation (B1/B2), and at follow-up (FU). |
From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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Fatigue (PROMIS-29)
Prazo: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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Assessed using the PROMIS-29 Fatigue domain T-score. Higher scores indicate greater fatigue. Improvement is defined as a decrease of ≥5 T-score points (MCID). Assessed once a week at baseline (A1), during SCS+rehabilitation (B1/B2), and at follow-up (FU). |
From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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Sleep disturbance (PROMIS-29)
Prazo: From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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Assessed using the PROMIS-29 Sleep Disturbance domain T-score. Higher scores indicate more sleep problems. Improvement is defined as a decrease of ≥5 T-score points (MCID). Assessed once a week at baseline (A1), during SCS+rehabilitation (B1/B2), and at follow-up (FU). |
From baseline through 12 weeks after start of SCS+rehabilitation and during a 5-week period approximately 6 months after implantation.
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Opioid and Analgesic Use
Prazo: Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
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Total opioid consumption quantified as milligrams of oral morphine equivalents (OMEQ) per day; non-opioid analgesics quantified in milligrams per day per medication. Assessed pre-implantation, end of SCS+rehabilitation (end of B2), and at follow-up (FU). |
Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
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Return to work
Prazo: Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
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Return to work status, quantified as hours worked per week (higher values indicate greater work participation). Assessed pre-implantation, end of SCS+rehabilitation (end of B2), and at follow-up (FU). |
Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
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Fear of movement (Tampa Scale)
Prazo: Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
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Fear of movement is assessed using the Tampa Scale for Kinesiophobia (TSK). Higher scores indicate greater fear of movement. Improvement is defined as a decrease of >6 points. Assessed pre-implantation, end of SCS+rehabilitation (end of B2), and at follow-up (FU). |
Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
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Patient-specific functioning
Prazo: Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
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Patient-Specific Functional Scale (PSFS), up to five activities selected in cooperation with personnel, rated 0-10 (higher scores indicate better function; average score reported). Assessed once a week at baseline (A1), during SCS+rehabilitation (B1/B2), and at follow-up (FU). |
Pre-implantation, at end of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
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Patient satisfaction
Prazo: End of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
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Patient Global Impression of Change (PGIC), 7-point Likert scale (1 = "very much worse" to 7 = "very much improved").
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End of 12-week SCS+rehabilitation, and at approximately 6 months after implantation.
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Lars-Petter Granan, Ph.D, Department of pain management and research, Oslo university hospital
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Dor
- Manifestações Neurológicas
- Doenças do Sistema Nervoso
- Doenças Neuromusculares
- Doenças do Sistema Nervoso Periférico
- Condições Patológicas, Sinais e Sintomas
- Sinais e sintomas
- Neuralgia
- Terapêutica
- Atendimento ao paciente
- Serviços de Saúde
- Instalações de saúde Força e serviços de trabalho
- Terapia comportamental
- Psicoterapia
- Disciplinas e atividades comportamentais
- Cuidados posteriores
- Continuidade do atendimento ao paciente
- Terapia de estimulação elétrica
- Terapia cognitivo -comportamental
- Terapia de aceitação e compromisso
- Reabilitação
- Modalidades de fisioterapia
- Estimulação da medula espinhal
Outros números de identificação do estudo
- 942321
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Os dados individuais dos participantes para todas as variáveis recolhidas, gerados durante o estudo e totalmente documentados num dicionário de dados anexo (detalhando nomes de variáveis, códigos, valores, unidades e derivações), ficarão disponíveis mediante pedido fundamentado de investigadores qualificados após a publicação. O acesso será restrito a investigadores qualificados que submetam uma candidatura e obtenham aprovação do comité de ética relevante e da autoridade de proteção de dados.
Os identificadores diretos e indiretos - incluindo nomes, datas exatas e outros riscos de reidentificação - serão sistematicamente removidos ou transformados (como ajustar datas por índice para manter intervalos enquanto se impede a ligação), garantindo que o conjunto de dados suporte análises secundárias robustas enquanto mantém a privacidade dos participantes.
Está prevista a publicação do protocolo do estudo.
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