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.

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.