Treatment for chronic pain Failed Back Surgery Syndrome
Conditions
Interventions
During the operative procedure standard Radio Frequency (RF) needles will be
used to transiently stimulate the nerve roots believed to carry sensory nerve
fibres that innervate the patients painful
Sponsors
Sint Antonius Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subject has been included for implantation according to standard criteria from the Dutch Neuromodulation Society 2. Chronic refractory pain as a result of post-laminectomy syndrome (FBSS) for at least 6 months 3. Subject is 18 years or older 4. Subject is able and willing to comply with the protocol and follow-up 5. Subject is fluent in the Dutch language 6. Subject is able to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Subject is under 18 years old 2. Subject is pregnant or nursing 3. Subject is unable to operate the EvokeTM SCS System 4. Subject is an unsuitable candidate for SCS
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study parameter, successful ECAP guided lead placement, will be determined at the end of phase 1, 2 (if applicable) and 3 (if applicable). The study will be considered a success if phase 3 is completed and passes the test for phase three. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following parameters will be measured as secondary study parameters: 1. Neurophysiological characterisations Recorded ECAP signals will be analysed after the procedure in the OR to describe their morphology and propagation characteristics - these parameters describe the type and physiology of the nerves activated by the epidural leads and nerve root stimulus 2. Patient reported outcomes (collected at baseline, 3-, 6- and 12-months follow-up). These will be collected via an online set of questionnaires including: • Health related quality of life (EQ-5D-5L) • Brief Pain Inventory (BPI) • Pain Detect • Oswestry Disability Index (ODI) • Hospital Anxiety and Depression Scale 2.1 (HADS) • Patient Global Impression of Change (PGIC) 3,4,5 and 7: Device data concerning programming parameters after initial programming and at follow-ups (contacts used, pulse width, stimulation frequency and amplitude etc.) will be collected to assess: if the best candidate electrodes identified in the operating room are used post operatively (3). This same device data will be used to assess; if and how initial programs change over time (4), to describe the programming parameters used (5), if ECAPs can still be recorded at long-term follow up visits, and if there are any detectable neurophysiological changes over time (7). 6. Procedural times will be captured on paper/electronic forms and programming time will be derived from the device data captured on the Clinical Interface | — |
Countries
Netherlands
Outcome results
None listed