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

13. oktober 2020 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

175

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

MedtronicNeuro

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

30. november 2017

Primær færdiggørelse (Faktiske)

4. februar 2019

Studieafslutning (Faktiske)

21. oktober 2019

Datoer for studieregistrering

Først indsendt

14. november 2017

Først indsendt, der opfyldte QC-kriterier

15. november 2017

Først opslået (Faktiske)

17. november 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. november 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. oktober 2020

Sidst verificeret

1. oktober 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MDT17053

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

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