Algovita Post-Market Clinical Study: Spinal Cord Stimulation to Treat Chronic Pain
- Conditions
- Chronic Pain
- Registration Number
- NCT02373540
- Lead Sponsor
- Nuvectra
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 91
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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).
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.
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.
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.
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.
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.
Trial Locations
- Locations (18)
Relieve Pain Center
🇺🇸San Diego, California, United States
Summit Healthcare Pain Clinic Associates
🇺🇸Show Low, Arizona, United States
Coastal Pain and Spinal Diagnostics
🇺🇸Carlsbad, California, United States
Samaritan Center for Medical Research
🇺🇸Los Gatos, California, United States
Restore Orthopedics and Spine Center
🇺🇸Orange, California, United States
Spine & Nerve Diagnostic Center
🇺🇸Roseville, California, United States
Vitamed Research
🇺🇸Rancho Mirage, California, United States
South Florida Clinical Research
🇺🇸South Miami, Florida, United States
Nona Medical Arts
🇺🇸Orlando, Florida, United States
Ephraim McDowell Regional Medical Center
🇺🇸Danville, Kentucky, United States
Nevada Advanced Pain Specialists
🇺🇸Reno, Nevada, United States
Brigham and Women's Hospital
🇺🇸Chestnut Hill, Massachusetts, United States
OMNI Pain and Precision Medicine
🇺🇸Utica, New York, United States
Garden State Pain Control
🇺🇸Clifton, New Jersey, United States
Pennsylvania Pain and Spine
🇺🇸Chalfont, Pennsylvania, United States
St. Luke's University Health Network
🇺🇸Bethlehem, Pennsylvania, United States
Universitatksklinikum Dusseldorf
🇩🇪Dusseldorf, Germany
NCN-Neurochirurgische Praxis Neuss
🇩🇪Neuss, Germany