Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Curonix LLC
With
Amphia ziekenhuis, Oosterhout, The Netherlands
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Appropriate Freedom SCS candidate as affirmed by study investigator
Candidate has a stable spine not suitable for further surgery as confirmed by physician
18 years of age or older (no upper age limit)
Diagnosis of failed back surgery syndrome (FBSS) characterized by chronic, intractable pain of the legs, back, or both legs and back
At least 6 months since last surgical procedure on the spine
Average score of 60mm or greater on a VAS scale (Scale of 0 to 100, where 0 equals no pain and 100 equals worst possible pain)
Pain duration of at least 6 months
Expected lifespan of at least two years
Able to comply with study requirements
Gives informed consent for study participation
You may not be if
A consistent VAS score of 100 over the past 24 hours as established at Visit 1
A co-existing condition that could increase the risk of SCS implantation (e.g., severe cardiac or respiratory disorders, coagulation disorder) or planned surgery within the study duration that could be compromised by SCS (e.g., diathermy)
Pregnant or planning to become pregnant
Known or suspected substance abuse within the last 2 years
Major psychiatric disorder (untreated or refractory to treatment) in the investigators opinion
Cognitive and/or behavioral issues that could impair study participation, (e.g., unreliability; defective memory; noncompliance in taking medications or keeping appointments; or impaired orientation to time, place, and events)
Documented allergy to Freedom SCS material components
Co-existing pain condition or participation in another clinical study that could confound the results of this study
History of another implanted medical device (e.g., explanted spinal cord stimulator, peripheral nerve stimulation, sacral nerve stimulator, pacemaker, or intrathecal drug delivery)
