Chronische pijnklachten Chronic Pain
Conditions
Interventions
Sponsors
St. Jude Medical
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Subject has chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome and intractable low back and leg pain. 2. Subject has a score of 6 or higher on the NRS for average pain specific to the area(s) of chronic pain being treated over the past 24 hours at the baseline visit. 3. Subject is considered by the Investigator as a candidate for implantation of a spinal cord stimulator system according to the system Instructions For Use. 4. Subject is 18 years of age or older at the time of enrollment. 5. Subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all study visits. 6. Subject has signed and received a copy of the Ethics Committee/Institutional Review Board (EC/IRB) approved informed consent.
Exclusion criteria
Exclusion criteria: 1. Subject currently has a spinal cord stimulation system implanted. 2. Subject has previously failed SCS therapy (either trial system evaluation or permanent implant). 3. Subject has a primary diagnosis of Peripheral Vascular Disease (PVD), Angina Pectoris, or Chronic Migraine. 4. Subject has or plans to have a Peripheral Nerve Stimulation system (PNS), Peripheral Nerve field Stimulation system (PNfS), Dorsal Root Ganglion system (DRG), or implantable infusion pump. 5. Subject is currently participating in another clinical investigation with an active treatment arm. 6. Subject unable to read and/or write.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective is to evaluate sustainable pain relief with a multiple waveform enabled neurostimulator. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives are to evaluate the psychosocial and functional responses to burst and tonic stimulation. | — |
Countries
Denmark, Finland, Germany, Italy, Netherlands, Spain, Switzerland, United Kingdom, United States of America
Outcome results
None listed