Chronic Pain
Conditions
Brief summary
The objective of this multicountry, multicentre, prospective study is to evaluate the long-term clinical effectiveness, safety, and performance of the Evoke System in the treatment of chronic pain of the trunk and/or limbs in a real-world population.
Interventions
A spinal cord stimulation system that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude
Sponsors
Saluda Medical Pty Ltd
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Eligible for therapy according to the Evoke System indications for use statement and labelling requirements * Willing and capable of giving informed consent and able to comply with study-related requirements, procedures, and visits * Baseline VAS pain rating ≥60 mm in the primary area of pain
Exclusion criteria
* No further
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Visual Analogue Scale (VAS) Pain | 3-months post-implant | Visual Analogue Scale (VAS) to rate pain intensity (0mm \[no pain\] to 100mm \[worst pain imaginable\]) |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of device- and procedure-related adverse events | through 60-months post-implant |
| Measurement of ECAPs by the Evoke SCS System | through 60-months post-implant |
Countries
Belgium, Germany, Netherlands, United Kingdom
Outcome results
None listed