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High-density in Spinal Cord Stimulation: Virtual Expert Registry (Discover)

28. januar 2021 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Faktiske)

272

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Belgia
      • Brussel, Belgia
        • UZ Brussel

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 65 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
spinal cord stimulation
Failed back surgery syndrome patients will receive high density spinal cord stimulation
Enhet: spinal cord stimulation
Andre navn:
  • high density spinal cord stimulation

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pain intensity with the Numeric Rating Scale (NRS)
Tidsramme: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
Pain relief by pain medication
Tidsramme: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
Questionnaire regarding the amount of pain relief by pain medication
The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
The abilities in daily living
Tidsramme: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
The functional abilities will be assessed with the Oswestry Low Back Pain Questionnaire.
The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
The current health status
Tidsramme: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
The health status will be observed with the Euroqol (EQ-5D-5L) questionnaire.
The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
Subjective sleep quality
Tidsramme: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
Subjective sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI).
The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
Patient's satisfaction
Tidsramme: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
Patient's satisfaction with the stimulation will be assessed with a 5 item Likert scale
The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pain area coverage
Tidsramme: The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
The patient has to draw the areas of pain coverage on a body shape figure
The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
Paresthesia threshold
Tidsramme: The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
Patient indicates the threshold at which he experiences paresthesia
The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
HD stim parameters
Tidsramme: The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
Questionnaire towards the clinician regarding the ideal high density parameters for this patient
The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
Battery efficiency of the neurostimulator
Tidsramme: The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
The battery usage will be measured by frequencies to recharge the battery.
The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
AdaptiveStim use (in case of Restore Sensor)
Tidsramme: The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
Acquire information on activity from the internal diary; amount of times that patients need to fit the ideal parameters themselves
The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
MRI need
Tidsramme: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
Questionnaire regarding the need for MR scans for other medical conditions
The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Universitair Ziekenhuis Brussel

Samarbeidspartnere

Medtronic

Publikasjoner og nyttige lenker

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Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juni 2016

Primær fullføring (Faktiske)

8. desember 2020

Studiet fullført (Faktiske)

8. desember 2020

Datoer for studieregistrering

Først innsendt

26. mai 2016

Først innsendt som oppfylte QC-kriteriene

26. mai 2016

Først lagt ut (Anslag)

1. juni 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. februar 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. januar 2021

Sist bekreftet

1. januar 2021

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Discover1

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