Algovita Post-Market Clinical Study: Spinal Cord Stimulation to Treat Chronic Pain

Nuvectra91 enrolled

Overview

The purpose of this study is to obtain real-world clinical outcome data for the Algovita Spinal Cord Stimulation system when used, on-label, according to the applicable directions for use.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Chronic Pain

Interventions

Algovita Spinal Cord Stimulation systemDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient is eligible for SCS therapy according to the Algovita SCS system Indications for Use statement * Patient had successful Algovita SCS system stimulation trial with an Algovita SCS system and will be implanted with a permanent Algovita SCS system; prior approval must be obtained from the Sponsor if another SCS system was used for the stimulation trial * Patient is willing and able to sign an IRB/EC approved informed consent, and in the United States, a Privacy Protection Authorization, as required Exclusion Criteria: * Patient is contraindicated for an Algovita SCS system * Patient has a cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or complete study assessments * Patient has a life expectancy of less than 2 years * Patient is participating in another clinical study that would confound data analysis * Patient has a coexisting pain condition that might confound pain ratings

Locations (18)

Summit Healthcare Pain Clinic Associates

Show Low, Arizona, United States

Coastal Pain and Spinal Diagnostics

Carlsbad, California, United States

Outcomes

Primary Outcomes

Percent reduction in targeted pain compared to baseline

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.

Time frame: 6 Month Follow-up Visit

Secondary Outcomes

Percent reduction in targeted pain compared to baseline

Time frame: 1, 3, 12, 18, and 24 Month Follow-up Visits

Percent change in targeted pain intensity compared to baseline

Percent reduction or actual reduction from baseline in targeted pain intensity, 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: 1, 3, 6, 12, 18, and 24 Month Follow-up Visits

Change in disability compared to baseline

Change from baseline in disability as measured by Oswestry Disability Index (ODI). The Oswestry Disability Index is scored between 0 and 100 with higher scores indicating a greater disability.

Time frame: 1, 3, 6, 12, 18, and 24 Month Follow-up Visits

Change in quality of life compared to baseline

Change from baseline in quality of life as measured by EQ-5D, a standardized measure of health status.

Time frame: 1, 3, 6, 12, 18, and 24 Month Follow-up Visits

Willingness to undergo procedure again

Data from ClinicalTrials.gov

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