Chronic Pain
Conditions
Keywords
spinal cord stimulation, chronic pain, failed back surgery syndrome
Brief summary
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.
Interventions
Sponsors
Bright Research Partners
Nuvectra
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent reduction in targeted pain compared to baseline | 6 Month Follow-up Visit | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent change in targeted pain intensity compared to baseline | 1, 3, 6, 12, 18, and 24 Month Follow-up Visits | 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. |
| Change in disability compared to baseline | 1, 3, 6, 12, 18, and 24 Month Follow-up Visits | 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. |
| Change in quality of life compared to baseline | 1, 3, 6, 12, 18, and 24 Month Follow-up Visits | Change from baseline in quality of life as measured by EQ-5D, a standardized measure of health status. |
| Percent reduction in targeted pain compared to baseline | 1, 3, 12, 18, and 24 Month Follow-up Visits | 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. |
| Rate of device-related and/or procedure-related Adverse Events (AEs) | From Implant through 24 Month Follow-up Visit | To record the rate of device-related and/or procedure-related Adverse Events (AEs). |
| Rate of surgical intervention of the SCS system | From Implant through 24 Month Follow-up Visit | To record the rate of surgical intervention of the SCS system. |
| Willingness to undergo procedure again | 1, 3, 6, 12, 18, and 24 Month Follow-up Visits | To record the participants willingness to undergo the procedure again using a question (yes/no) if the participant would be willing to undergo the procedure again. |
Countries
Germany, United States
Outcome results
None listed