High-density in Spinal Cord Stimulation: Virtual Expert Registry (Discover)
28 de janeiro de 2021 atualizado por: Moens Maarten, Universitair Ziekenhuis Brussel
This is a prospective, multi-center, observational follow-up study observing the effectiveness of high density spinal cord stimulation in patients with failed back surgery syndrome patients with back and leg pain.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
DISCOVER will measure the effectiveness of high-density spinal cord stimulation for treatment of chronic back and leg pain.
Identification of clinical effective parameters concerning location of active electrodes, frequency, pulse duration, amplitude and battery consumption are, besides safety, the major outcome parameters of this study.
Tipo de estudo
Observacional
Inscrição (Real)
272
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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Brussel, Bélgica
- UZ Brussel
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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
18 anos a 65 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
Patients with chronic back and leg pain (due to Failed Back Surgery Syndrome) who either received SCS or have not sufficient pain reduction with traditional parameters or patients with chronic back and leg pain who are candidate for SCS will receive HD SCS.
Descrição
Inclusion Criteria:
- Failed Back Surgery Syndrome patients (FBSS) with insufficient pain reduction with conventional SCS or FBSS patients suitable for SCS
- Age > 18 years
- Chronic pain as a result of FBSS that exists for at least 6 months with a pain intensity 5 or higher measured on numeric rating scale (NRS)
- Patient has been informed of the study procedures and has given written informed consent
- Patient willing to comply with study protocol including attending the study visits
Exclusion Criteria:
- Expected inability of patients to receive or properly operate the spinal cord stimulation system
- History of coagulation disorders, lupus erythematosus, diabetic neuropathy, rheumatoid arthritis or morbus Bechterew
- Active malignancy
- Addiction to any of the following drugs, alcohol (5E/day) and/or medication
- Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by investigator
- Immune deficiency (HIV positive, immunosuppressiva, etc.)
- Life expectancy < 1 year
- Local infection or other skin disorder at site of incision
- Pregnancy
- Other implanted active medical device
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
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
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spinal cord stimulation
Failed back surgery syndrome patients will receive high density spinal cord stimulation
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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 with the Numeric Rating Scale (NRS)
Prazo: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
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The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
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Pain relief by pain medication
Prazo: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
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Questionnaire regarding the amount of pain relief by pain medication
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The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
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The abilities in daily living
Prazo: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
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The functional abilities will be assessed with the Oswestry Low Back Pain Questionnaire.
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The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
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The current health status
Prazo: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
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The health status will be observed with the Euroqol (EQ-5D-5L) questionnaire.
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The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
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Subjective sleep quality
Prazo: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
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Subjective sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI).
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The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
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Patient's satisfaction
Prazo: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
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Patient's satisfaction with the stimulation will be assessed with a 5 item Likert scale
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The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Pain area coverage
Prazo: The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
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The patient has to draw the areas of pain coverage on a body shape figure
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The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
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Paresthesia threshold
Prazo: The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
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Patient indicates the threshold at which he experiences paresthesia
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The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
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HD stim parameters
Prazo: The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
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Questionnaire towards the clinician regarding the ideal high density parameters for this patient
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The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
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Battery efficiency of the neurostimulator
Prazo: The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
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The battery usage will be measured by frequencies to recharge the battery.
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The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
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AdaptiveStim use (in case of Restore Sensor)
Prazo: The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
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Acquire information on activity from the internal diary; amount of times that patients need to fit the ideal parameters themselves
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The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
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MRI need
Prazo: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
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Questionnaire regarding the need for MR scans for other medical conditions
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The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Song Z, Meyerson BA, Linderoth B. High-Frequency (1 kHz) Spinal Cord Stimulation-Is Pulse Shape Crucial for the Efficacy? A Pilot Study. Neuromodulation. 2015 Dec;18(8):714-20. doi: 10.1111/ner.12344. Epub 2015 Sep 6.
- Sweet J, Badjatiya A, Tan D, Miller J. Paresthesia-Free High-Density Spinal Cord Stimulation for Postlaminectomy Syndrome in a Prescreened Population: A Prospective Case Series. Neuromodulation. 2016 Apr;19(3):260-7. doi: 10.1111/ner.12357. Epub 2015 Oct 20.
- Goudman L, Rigoard P, Billot M, De Smedt A, Roulaud M, Consortium D, Moens M; Discover Consortium. Spinal Cord Stimulation-Naive Patients vs Patients With Failed Previous Experiences With Standard Spinal Cord Stimulation: Two Distinct Entities or One Population? Neuromodulation. 2023 Jan;26(1):157-163. doi: 10.1016/j.neurom.2022.04.037. Epub 2022 May 10.
- Goudman L, De Smedt A, Eldabe S, Rigoard P, Linderoth B, De Jaeger M, Moens M; Discover Consortium. High-dose spinal cord stimulation for patients with failed back surgery syndrome: a multicenter effectiveness and prediction study. Pain. 2021 Feb 1;162(2):582-590. doi: 10.1097/j.pain.0000000000002035.
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
1 de junho de 2016
Conclusão Primária (Real)
8 de dezembro de 2020
Conclusão do estudo (Real)
8 de dezembro de 2020
Datas de inscrição no estudo
Enviado pela primeira vez
26 de maio de 2016
Enviado pela primeira vez que atendeu aos critérios de CQ
26 de maio de 2016
Primeira postagem (Estimativa)
1 de junho de 2016
Atualizações de registro de estudo
Última Atualização Postada (Real)
1 de fevereiro de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
28 de janeiro de 2021
Última verificação
1 de janeiro de 2021
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- Discover1
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