Algovita Spinal Cord Stimulation System Hi-Fi Study

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Chronic Pain

Intervention / Treatment
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* Device: Ultra-high pulse width stimulation
* Device: Traditional pulse width stimulation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: During the Treatment Phase of the study, all subjects will receive both treatments under a crossover design. Subjects will undergo 12 weeks of treatment in each group with a 1-week washout between groups.
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 |