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

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Pain
• Intervention / Treatment: Device: Ultra-high pulse width stimulation; Device: Traditional pulse width stimulation

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ultra-high pulse width; Ultra-high pulse width stimulation using the Algovita System	Device: Ultra-high pulse width stimulation; Algovita Spinal Cord Stimulation System with associated components
Active Comparator: Traditional pulse width; Traditional pulse width stimulation using the Algovita System	Device: Traditional pulse width stimulation; Algovita Spinal Cord Stimulation System with associated components

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of targeted pain reduction compared to baseline in each treatment arm	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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of targeted pain reduction compared to baseline in each treatment arm	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	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	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	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	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	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	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	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	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	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	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	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	Rate of surgical re-intervention of the SCS system for participants with a permanent implant.	From Permanent Implant through Month 24

Collaborators and Investigators

• Sponsor: Nuvectra
• Collaborators: Bright Research Partners
• Investigators: Study Director: Ben Tranchina, Nuvectra

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2018
• Primary Completion (Actual): April 27, 2020
• Study Completion (Actual): April 27, 2020

Study Registration Dates

• First Submitted: July 26, 2018
• First Submitted That Met QC Criteria: August 7, 2018
• First Posted (Actual): August 9, 2018

Study Record Updates

• Last Update Posted (Actual): March 11, 2021
• Last Update Submitted That Met QC Criteria: March 9, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: CLRE 1092

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes