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Vectors Post Market: A Study to Assess Pain Relief Using Spinal Cord Stimulation

13. oktober 2020 oppdatert av: MedtronicNeuro

Vectors Post Market: A Study to Assess Pain Relief Using Spinal Cord Stimulation (SCS) With High Dose (HD) Stimulation Parameters

This is a prospective, single-arm, multi-center study evaluating the efficacy of spinal cord stimulation (SCS) therapy for pain relief using high dose (HD) stimulation parameters delivered to neural targets identified during current commercial trial stimulation procedures. The study will evaluate changes in back and leg pain from baseline to 3, 6, and 12 months.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

175

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

  • Forente stater
    • California
      • La Mesa, California, Forente stater, 91942-8901
        • Pain Consultants of San Diego
      • Orange, California, Forente stater, 92868
        • Restore Orthopedics and Spine Center
    • Delaware
      • Wilmington, Delaware, Forente stater, 19803
        • Center for Interventional Pain and Spine
    • Georgia
      • Stockbridge, Georgia, Forente stater, 30281-5023
        • Pain Care
    • Maryland
      • Oxon Hill, Maryland, Forente stater, 20745
        • National Spine and Pain
    • Michigan
      • Wyoming, Michigan, Forente stater, 49519
        • Michigan Pain Consultants
    • Nevada
      • Henderson, Nevada, Forente stater, 89052
        • Comprehensive and Interventional Pain Management
    • New Jersey
      • Voorhees, New Jersey, Forente stater, 08043-3512
        • The Pain Management Center
    • New York
      • Rochester, New York, Forente stater, 14618
        • University of Rochester Neurosurgery Partners Pain Management
    • North Carolina
      • Huntersville, North Carolina, Forente stater, 28078
        • Carolinas Pain Center
    • Ohio
      • Columbus, Ohio, Forente stater, 43210
        • The Ohio State University Wexner Medical CEnter
    • Pennsylvania
      • Allentown, Pennsylvania, Forente stater, 18103
        • Lehigh Valley Healthcare Network
      • Bethlehem, Pennsylvania, Forente stater, 18015
        • Saint Luke's Neurosurgical Associates
      • Sewickley, Pennsylvania, Forente stater, 15134
        • Pain Diagnostics and Interventional Care
      • Trevose, Pennsylvania, Forente stater, 19053
        • Delaware Valley Pain and Spine Institute
    • South Carolina
      • Charleston, South Carolina, Forente stater, 29406
        • Lowcountry Orthopaedics/Coastal Carolina Research Center
      • Spartanburg, South Carolina, Forente stater, 29303
        • Carolina Center for Advanced Management of Pain
    • Texas
      • Tyler, Texas, Forente stater, 75701
        • Precision Spine Care
    • Virginia
      • Roanoke, Virginia, Forente stater, 24014
        • Carilion Clinic Roanoke Memorial Hospital
    • Washington
      • Spokane, Washington, Forente stater, 99201
        • Northwest Pain Care

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 og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Candidate per labeling for an SCS system as an aid in the management of chronic, intractable low back and leg pain
  • Presence of low back and leg pain
  • Moderate to crippled disability due to pain
  • Stable pain medications for back and leg pain for at least 28 days prior to enrollment
  • Willing and able to not increase pain medications through the 3-Month visit

Exclusion Criteria:

  • Previously trialed or implanted with stimulator or intrathecal drug delivery system
  • Current diagnosis of moderate to severe central lumbar spinal stenosis
  • Major psychiatric comorbidity or other progressive diseases
  • Serious drug-related behavioral issues
  • Pregnant or planning on becoming pregnant
  • Unable to achieve supine position

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Treated
Enrolled subjects who are implanted with a spinal cord stimulation system that is activated.
Enhet: Spinal Cord Stimulation System
Implanted neurostimulation system (neurostimulator and leads) with high dose stimulation parameters.
Andre navn:
  • Medtronic RestoreSensor SureScan MRI neurostimulation system
  • Medtronic Intellis AdaptiveStim neurostimulation system

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Overall Pain Intensity on the Visual Analog Scale (0-100)
Tidsramme: Baseline to 3 months

Demonstrate a significant improvement in overall pain intensity as measured by the Visual Analog Scale (VAS).

The VAS ranges from 0 (no pain) to 100 (worst pain imaginable). The change in overall pain intensity is calculated as the Baseline VAS minus the 3-month VAS, where a positive value indicates an improvement (ie, reduction) in pain from Baseline to 3 months. Higher values represent a larger reduction (ie, greater improvement) in pain.

The change in overall pain intensity as measured by the VAS can range from -100 (worsening in pain from 0 at baseline to 100 at 3 months) to 100 (improvement in pain from 100 at baseline to 0 at 3 months). It should be noted that while the change in VAS can range from -100 to 100, no subjects had a VAS of 0 at baseline, as the presence of pain was required for eligibility for inclusion in the study.
Baseline to 3 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall Pain Efficacy Responder Rate
Tidsramme: Baseline to 3 months

Characterize the overall pain efficacy responder rate, where the responder rate is the percentage of subjects who experience at least a 50% improvement in overall pain, as measured by the Visual Analog Scale (VAS).

The VAS ranges from 0 (no pain) to 100 (worst pain imaginable). The percent improvement for each subject was calculated as [100*(Baseline VAS - 3-month VAS)/Baseline VAS], where a positive number represents an improvement, and the larger the number the greater the percent improvement. If the percent improvement from baseline to 3 months was at least 50%, the subject was considered a responder.

The percentage of subjects who experience at least a 50% improvement in overall pain can range from 0% (no responders) to 100% (all responders).
Baseline to 3 months
Low Back Pain Efficacy Responder Rate
Tidsramme: Baseline to 3 months

Characterize the low back pain efficacy responder rate, where the responder rate is the percentage of subjects who experience at least a 50% improvement in low back pain, as measured by the Visual Analog Scale (VAS).

The VAS ranges from 0 (no pain) to 100 (worst pain imaginable). The percent improvement for each subject was calculated as [100*(Baseline VAS - 3-month VAS)/Baseline VAS], where a positive number represents an improvement, and the larger the number the greater the percent improvement. If the percent improvement from baseline to 3 months was at least 50%, the subject was considered a responder.

The percentage of subjects who experience at least a 50% improvement in low back pain can range from 0% (no responders) to 100% (all responders).
Baseline to 3 months
Leg Pain Efficacy Responder Rate
Tidsramme: Baseline to 3 months

Characterize the leg pain efficacy responder rate, where the responder rate is the percentage of subjects who experience at least a 50% improvement in leg pain, as measured by the Visual Analog Scale (VAS).

The VAS ranges from 0 (no pain) to 100 (worst pain imaginable). The percent improvement for each subject was calculated as [100*(Baseline VAS - 3-month VAS)/Baseline VAS], where a positive number represents an improvement, and the larger the number the greater the percent improvement. If the percent improvement from baseline to 3 months was at least 50%, the subject was considered a responder.

The percentage of subjects who experience at least a 50% improvement in leg pain can range from 0% (no responders) to 100% (all responders).
Baseline to 3 months

Samarbeidspartnere og etterforskere

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

Sponsor

MedtronicNeuro

Etterforskere

  • Studieleder: Vectors Post Market Clinical Research Study Team, Medtronic Restorative Therapies, Pain Therapy

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

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 (Faktiske)

30. november 2017

Primær fullføring (Faktiske)

4. februar 2019

Studiet fullført (Faktiske)

21. oktober 2019

Datoer for studieregistrering

Først innsendt

14. november 2017

Først innsendt som oppfylte QC-kriteriene

15. november 2017

Først lagt ut (Faktiske)

17. november 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. november 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. oktober 2020

Sist bekreftet

1. oktober 2020

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • MDT17053

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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