- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03622866
Algovita Spinal Cord Stimulation System Hi-Fi Study
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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Arizona
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Tucson, Arizona, Vereinigte Staaten, 85712
- Pain Institute of Southern Arizona
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California
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Newport Beach, California, Vereinigte Staaten, 92660
- Newport Beach Headache & Pain
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Santa Rosa, California, Vereinigte Staaten, 95401
- Summit Pain Alliance
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Colorado
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Colorado Springs, Colorado, Vereinigte Staaten, 80919
- Spinal Diagnostics & Pain Management
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Kansas
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Overland Park, Kansas, Vereinigte Staaten, 66210
- Mid-America PolyClinic & Interventional Pain Management Specialists
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Louisiana
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Shreveport, Louisiana, Vereinigte Staaten, 71105
- WK River Cities Clinical Research Center
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Massachusetts
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Chestnut Hill, Massachusetts, Vereinigte Staaten, 02467
- Brigham & Women's Hospital
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Ohio
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Chillicothe, Ohio, Vereinigte Staaten, 45601
- Adena Spine Center
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Cleveland, Ohio, Vereinigte Staaten, 44195
- Cleveland Clinic Foundation
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Rhode Island
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Providence, Rhode Island, Vereinigte Staaten, 02903
- Comprehensive Spine Center at Rhode Island Hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Crossover-Aufgabe
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Aktiver Komparator: Ultra-high pulse width
Ultra-high pulse width stimulation using the Algovita System
|
Algovita Spinal Cord Stimulation System with associated components
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Aktiver Komparator: Traditional pulse width
Traditional pulse width stimulation using the Algovita System
|
Algovita Spinal Cord Stimulation System with associated components
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Effectiveness of targeted pain reduction compared to baseline in each treatment arm
Zeitfenster: 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
Zeitfenster: From Permanent Implant through Week 25
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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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Effectiveness of targeted pain reduction compared to baseline in each treatment arm
Zeitfenster: 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
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Effectiveness of back and/or leg pain reduction compared to baseline in each treatment arm
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
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Clinician Global Impression of Change score in each treatment arm
Zeitfenster: Weeks 12 and 25, and Months 12, 18 and 24
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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).
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Weeks 12 and 25, and Months 12, 18 and 24
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Change in disability compared to baseline in each treatment arm
Zeitfenster: Weeks 12 and 25, and Months 12, 18 and 24
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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.
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Weeks 12 and 25, and Months 12, 18 and 24
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Change in quality of life compared to baseline in each treatment arm
Zeitfenster: Weeks 12 and 25, and Months 12, 18 and 24
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The change from baseline in quality of life as measured by the EQ-5D-5L, a standardized measure of health status.
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Weeks 12 and 25, and Months 12, 18 and 24
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Change in patient activity per the Pain Disability Index score in each treatment arm
Zeitfenster: 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
Zeitfenster: 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
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Participant satisfaction per the subject satisfaction survey outcome in each treatment arm
Zeitfenster: 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.
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Weeks 12 and 25, and Months 12, 18 and 24
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Evaluation of trial success rates
Zeitfenster: From Trial Implant to End of Trail
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The percentage of participants that have a successful trial phase, defined as at least a 50 percent reduction in targeted pain compared to baseline.
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From Trial Implant to End of Trail
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Rate of surgical re-intervention of the SCS system
Zeitfenster: From Permanent Implant through Month 24
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Rate of surgical re-intervention of the SCS system for participants with a permanent implant.
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From Permanent Implant through Month 24
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Studienleiter: Ben Tranchina, Nuvectra
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CLRE 1092
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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