Chronic pain as a result of FBSS chronic nerve pain failed back surgery syndrome
Conditions
Interventions
one group will recieve spinal anesthesia during implantation of de electrodes,
the other group recieves local anaesthesia with sedation.
Sponsors
Elisabeth-Tweesteden ziekenhuis
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: • Subject has been diagnosed with chronic, intractable leg and/or back pain (NPRS >= 6), FBSS, which has been refractory to conservative therapy for at least 6 months. • Subject has been approved by the Investigator to undergo a trial of SCS implantation. • Subject is an appropriate candidate for the surgical procedures required for SCS based on the clinical judgment of the implanting physician. • Subject is on a stable dose (no new, discontinued, or changes in dose) of all prescribed pain medication for at least 30 days prior to baseline evaluation. • Subject is willing and capable of giving written informed consent. • Subject is willing and able to comply with study-related requirements, procedures, and visits. • Subject is at least 18 years of age
Exclusion criteria
Exclusion criteria: • Subject has a medical condition or pain in area(s) that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator. • Subject is not an SCS candidate due to anatomical or structural findings and/or changes which would benefit from surgical intervention as determined by the Investigator. • Subject has evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance with intervention and/or ability to evaluate treatment outcomes as determined by the Investigator. • Subject who has had another neuromodulation system. • Subject has a condition currently requiring or likely to require the use of MRI or diathermy. • Subject is not a good surgical candidate (e.g., has an uncontrolled coagulation disorder, bleeding diathesis, progressive peripheral vascular disease, uncontrolled diabetes mellitus, or cannot come off anticoagulant therapy for procedure). • Subject is concomitantly participating in another clinical study unless pre-approved by the principal investigator. • Subject is involved in a process (e.g., involved in an injury claim under current litigation) in which pain relief may be considered detrimental (i.e., secondary gains).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Subject experience will be evaluated using a numerical pain rating scale (NPRS) to assess the degree of pain/discomfort during the lead implantation procedure. A clinically meaningful difference in NPRS is set at two points on the NPRS scale (0-10) | — |
Secondary
| Measure | Time frame |
|---|---|
| • To evaluate the difference in amount of medication for sedation required, including additional pain medication. Dosages administered will be captured during procedure. • Physician and patient satisfaction will be evaluated using a 5-point Likert scale. • The effects of spinal and local anaesthesia on ECAP generation will be assessed in the following ways. These evaluations will take place intra-operatively, post-operatively in the recovery room ( | — |
Countries
Netherlands
Outcome results
None listed