Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Algovita Spinal Cord Stimulation System Hi-Fi Study

9 marzo 2021 aggiornato da: Nuvectra

Clinical Trial Comparing Ultra-High Versus Traditional Pulse Widths Using the ALGOVITA® SCS System High Fidelity Stimulation in the Treatment of Persistent or Recurrent Back and/or Leg Pain Following Spinal Surgery

The objective of this study is to obtain post-market clinical outcome data for the Algovita SCS System when used on-label, according to the applicable directions for use, using high fidelity tonic stimulation at either ultra-high pulse width or traditional pulse width for the treatment of persistent or recurrent back and/or leg pain following spinal surgery.

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

20

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Arizona
      • Tucson, Arizona, Stati Uniti, 85712
        • Pain Institute of Southern Arizona
    • California
      • Newport Beach, California, Stati Uniti, 92660
        • Newport Beach Headache & Pain
      • Santa Rosa, California, Stati Uniti, 95401
        • Summit Pain Alliance
    • Colorado
      • Colorado Springs, Colorado, Stati Uniti, 80919
        • Spinal Diagnostics & Pain Management
    • Kansas
      • Overland Park, Kansas, Stati Uniti, 66210
        • Mid-America PolyClinic & Interventional Pain Management Specialists
    • Louisiana
      • Shreveport, Louisiana, Stati Uniti, 71105
        • WK River Cities Clinical Research Center
    • Massachusetts
      • Chestnut Hill, Massachusetts, Stati Uniti, 02467
        • Brigham & Women's Hospital
    • Ohio
      • Chillicothe, Ohio, Stati Uniti, 45601
        • Adena Spine Center
      • Cleveland, Ohio, Stati Uniti, 44195
        • Cleveland Clinic Foundation
    • Rhode Island
      • Providence, Rhode Island, Stati Uniti, 02903
        • Comprehensive Spine Center at Rhode Island Hospital

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Patients with FBSS defined as persistent or recurrent back and/or leg pain despite one or more anatomically successful back surgeries for the same original pain.
  • Age 18-75 years old at consent.
  • Targeted pain intensity of ≥ 5 out of 10 on the Baseline visit NRS.
  • ODI score of 41-80 out of 100 at the Baseline visit.
  • Appropriate candidate for the surgical procedure and Algovita SCS therapy based on the clinical judgment of the investigator and the Algovita Instructions for Provider (IFP) in the Nuvectra product manuals.
  • On stable pain medications for at least 28 days prior to consent. Stable is defined as no new or discontinued pain medications and no changes to total daily dose of any pain medications.
  • Willing and capable of providing informed consent.
  • Willing and able of complying with the study-related requirements, procedures, and visits.
  • Speaks English as a primary language (as the Algovita patient manuals are only currently available in English).
  • Has adequate cognitive ability to use the subject devices (e.g., PPC, PoP), as determined by the investigator.

Exclusion Criteria:

  • Has a medical/psychological/psychiatric condition/disorder that could interfere with study procedures as determined by the investigator.
  • Has a coexisting pain condition that might confound pain ratings, as determined by the investigator.
  • Has a condition currently requiring or likely to require the use of MRI or diathermy.
  • Has an existing drug pump, SCS System, or other active implantable device.
  • Has any prior SCS experience.
  • Pregnant or planning to become (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile, or be at least 2 years postmenopausal).
  • For subjects with diabetes, HbA1c ≥ 8.5% as measured at the Baseline visit (or within the 3 months prior to the Baseline visit).
  • Participating in another clinical trial that could affect the outcomes or requirements of this study as determined by the investigator.
  • Involved in an injury claim under current litigation or have a pending or approved workers compensation claim.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Ultra-high pulse width
Ultra-high pulse width stimulation using the Algovita System
Dispositivo: Ultra-high pulse width stimulation
Algovita Spinal Cord Stimulation System with associated components
Comparatore attivo: Traditional pulse width
Traditional pulse width stimulation using the Algovita System
Dispositivo: Traditional pulse width stimulation
Algovita Spinal Cord Stimulation System with associated components

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Effectiveness of targeted pain reduction compared to baseline in each treatment arm
Lasso di tempo: Week 25

The percentage of participants who experience at least a 50 percent reduction in targeted pain from baseline, as assessed by Numeric Rating Scale (NRS). The Numeric Rating Scale (NRS) will range from 0 to 10 with a higher score indicating a higher level of pain.

Effectiveness will be compared both descriptively and statistically between the two randomized treatment groups using crossover analysis methods.
Week 25
Rate of serious study-related adverse events (AEs) in each treatment arm
Lasso di tempo: From Permanent Implant through Week 25
The rate of serious study-related AEs. Study-related AEs are defined as any device, procedure and therapy/stimulation-related AEs.
From Permanent Implant through Week 25

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Effectiveness of targeted pain reduction compared to baseline in each treatment arm
Lasso di tempo: Week 12 and Months 12, 18 and 24
The percentage of participants who experience at least a 50 percent reduction in targeted pain as assessed by Numeric Rating Scale (NRS). The Numeric Rating Scale (NRS) will range from 0 to 10 with a higher score indicating a higher level of pain.
Week 12 and Months 12, 18 and 24
Effectiveness of back and/or leg pain reduction compared to baseline in each treatment arm
Lasso di tempo: Weeks 12 and 25, and Months 12, 18 and 24
The percentage of participants who experience at least a 50 percent reduction in back and/or leg pain as assessed by Numeric Rating Scale (NRS). The Numeric Rating Scale (NRS) will range from 0 to 10 with a higher score indicating a higher level of pain.
Weeks 12 and 25, and Months 12, 18 and 24
Effectiveness of targeted, back and/or leg pain reduction compared to baseline in each treatment arm
Lasso di tempo: Weeks 12 and 25, and Months 12, 18 and 24
The percentage of participants who experience at least a 50 percent reduction in targeted, back and/or leg pain as assessed by a Visual Analog Scale (VAS). The Visual Analog Scale (VAS) will range from 0 mm (no pain) to 100 mm (worst pain imaginable). A higher score indicates a higher level of pain.
Weeks 12 and 25, and Months 12, 18 and 24
Change in targeted, back and/or leg pain compared to baseline in each treatment arm
Lasso di tempo: Weeks 12 and 25, and Months 12, 18 and 24
The mean change and percent change from baseline in targeted, back and/or leg pain as assessed by a Numeric Rating Scale (NRS). The Numeric Rating Scale (NRS) will range from 0 to 10 with a higher score indicating a higher level of pain.
Weeks 12 and 25, and Months 12, 18 and 24
Change in targeted, back and/or leg pain compared to baseline in each treatment arm
Lasso di tempo: Weeks 12 and 25, and Months 12, 18 and 24
The mean change and percent change from baseline in targeted, back and/or leg pain as assessed by a Visual Analog Scale (VAS). The Visual Analog Scale (VAS) will range from 0 mm (no pain) to 100 mm (worst pain imaginable). A higher score indicates a higher level of pain.
Weeks 12 and 25, and Months 12, 18 and 24
Clinician Global Impression of Change score in each treatment arm
Lasso di tempo: Weeks 12 and 25, and Months 12, 18 and 24
The Investigator's assessment of change in the overall status of the participant using the standard Clinician Global Impression of Change ranging from 1 (very much improved) to 7 (very much worse).
Weeks 12 and 25, and Months 12, 18 and 24
Change in disability compared to baseline in each treatment arm
Lasso di tempo: Weeks 12 and 25, and Months 12, 18 and 24
The change from baseline in disability as measured by the Oswestry Disability Index. The Oswestry Disability Index is scored between 0 and 100 with higher scores indicating a greater disability.
Weeks 12 and 25, and Months 12, 18 and 24
Change in quality of life compared to baseline in each treatment arm
Lasso di tempo: Weeks 12 and 25, and Months 12, 18 and 24
The change from baseline in quality of life as measured by the EQ-5D-5L, a standardized measure of health status.
Weeks 12 and 25, and Months 12, 18 and 24
Change in patient activity per the Pain Disability Index score in each treatment arm
Lasso di tempo: Weeks 12 and 25, and Months 12, 18 and 24
The change from baseline in patient activity as measured by the Pain Disability Index score. The Pain Disability Index is a self-report asking participants to rate how much pain interferes in seven areas of life activity using a 0 (no disability) to 10 (total disability) numeric rating scale.
Weeks 12 and 25, and Months 12, 18 and 24
Patient Global Impression of Change score in each treatment arm
Lasso di tempo: Weeks 12 and 25, and Months 12, 18 and 24
The participant's assessment of change in their overall status using the standard Patient Global Impression of Change ranging from 1 (very much improved) to 7 (very much worse).
Weeks 12 and 25, and Months 12, 18 and 24
Participant satisfaction per the subject satisfaction survey outcome in each treatment arm
Lasso di tempo: Weeks 12 and 25, and Months 12, 18 and 24
Participant satisfaction using a subject satisfaction survey (5 point Likert scale format) ranging from very satisfied to very dissatisfied.
Weeks 12 and 25, and Months 12, 18 and 24
Evaluation of trial success rates
Lasso di tempo: From Trial Implant to End of Trail
The percentage of participants that have a successful trial phase, defined as at least a 50 percent reduction in targeted pain compared to baseline.
From Trial Implant to End of Trail
Rate of surgical re-intervention of the SCS system
Lasso di tempo: From Permanent Implant through Month 24
Rate of surgical re-intervention of the SCS system for participants with a permanent implant.
From Permanent Implant through Month 24

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Nuvectra

Collaboratori

Bright Research Partners

Investigatori

  • Direttore dello studio: Ben Tranchina, Nuvectra

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

2 novembre 2018

Completamento primario (Effettivo)

27 aprile 2020

Completamento dello studio (Effettivo)

27 aprile 2020

Date di iscrizione allo studio

Primo inviato

26 luglio 2018

Primo inviato che soddisfa i criteri di controllo qualità

7 agosto 2018

Primo Inserito (Effettivo)

9 agosto 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

11 marzo 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 marzo 2021

Ultimo verificato

1 marzo 2021

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CLRE 1092

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

prodotto fabbricato ed esportato dagli Stati Uniti

Sì

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Dolore cronico

Prove cliniche su Ultra-high pulse width stimulation

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Bahrain

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

3
Sottoscrivi