chronische hardnekkige pijn in romp en/of ledematen Chronic pain
Conditions
Interventions
SCS trial stimulation
Anatomical lead placement
Spinal Cord Stimulation
Targeted lead placement
Trial stimulation
Sponsors
St. Jude Medical
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Patient is indicated for SCS therapy in accordance with the approved labeling. 2. Patient*s pain profile indicates appropriate lead placement would be at one or more levels from T7 to T10, to achieve pain coverage. 3. Patient has a baseline score on the NRS *6 over the past 24 hours for *average overall pain* specific to the area(s) of chronic pain that will be treated with spinal cord stimulation. 4. Patient is considered by the Study Investigator as a candidate for implantation of a spinal cord stimulator system according to the system Instructions for Use. 5. Patient is >18 years of age at the time of enrollment. 6. Patient is willing to adhere to the study requirements, including compliance with and completion of all study visits. 7. Patient has signed and received a copy of the EC/IRB approved informed consent.
Exclusion criteria
Exclusion criteria: 1. Patient currently has a spinal cord stimulation system implanted. 2. Patient has previously failed a spinal cord stimulation therapy (either trial system evaluation or permanent system implant). 3. Patient has a primary diagnosis of Peripheral Vascular Disease (PVD), Angina Pectoris, or Chronic Migraine. 4. Patient is scheduled to undergo an on-the-table trial evaluation (aka all-in-one procedure). 5. Patient is scheduled to be implanted with (a) surgical paddle trial lead(s). 6. Patient is currently participating in another clinical investigation with an active treatment arm. 7. Patient is unable to read and/or write.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the qualification rate for permanent system implant at the end of the initial trial evaluation period Qualification for permanent system implant is defined by a composite in which a subject meets all of the following conditions: * >50% patient reported pain relief (PRP) at the end of the trial evaluation * The trial evaluation period lasted for a minimum of 3 days * Physician recommends subject for permanent system implant * Subject reports a willingness to pursue a permanent system implant Subjects are not qualified for permanent system implant if they meet both of the following: * *50% PRP (patient reported pain relief) at the end of the trial evaluation * Trial evaluation period lasted for a minimum of 5 days | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint is the rate of physician preference for anatomic placement versus targeted placement at the end of the study. | — |
Countries
Austria, Canada, Germany, Italy, Netherlands, Sweden, United Kingdom, United States of America
Outcome results
None listed