Algovita Spinal Cord Stimulation System Hi-Fi Study

Nuvectra20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Chronic Pain

Interventions

Ultra-high pulse width stimulationDEVICE

Algovita Spinal Cord Stimulation System with associated components

Traditional pulse width stimulationDEVICE

Algovita Spinal Cord Stimulation System with associated components

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (10)

Pain Institute of Southern Arizona

Tucson, Arizona, United States

Newport Beach Headache & Pain

Newport Beach, California, United States

Summit Pain Alliance

Santa Rosa, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: From Permanent Implant through Week 25

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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Spinal Diagnostics & Pain Management

Colorado Springs, Colorado, United States

Mid-America PolyClinic & Interventional Pain Management Specialists

Overland Park, Kansas, United States

WK River Cities Clinical Research Center

Shreveport, Louisiana, United States

Brigham & Women's Hospital

Chestnut Hill, Massachusetts, United States

Adena Spine Center

Chillicothe, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Comprehensive Spine Center at Rhode Island Hospital

Providence, Rhode Island, United States

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: From Permanent Implant through Month 24