High-density in Spinal Cord Stimulation: Virtual Expert Registry (Discover)
28 janvier 2021 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Réel)
272
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Brussel, Belgique
- UZ Brussel
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
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.
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
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spinal cord stimulation
Failed back surgery syndrome patients will receive high density spinal cord stimulation
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Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Pain intensity with the Numeric Rating Scale (NRS)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Pain area coverage
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 juin 2016
Achèvement primaire (Réel)
8 décembre 2020
Achèvement de l'étude (Réel)
8 décembre 2020
Dates d'inscription aux études
Première soumission
26 mai 2016
Première soumission répondant aux critères de contrôle qualité
26 mai 2016
Première publication (Estimation)
1 juin 2016
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
1 février 2021
Dernière mise à jour soumise répondant aux critères de contrôle qualité
28 janvier 2021
Dernière vérification
1 janvier 2021
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Discover1
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