Failed Back Surgery Syndrome
Conditions
Keywords
Spinal cord stimulation, interview
Brief summary
This is a prospective study in which the investigators will describe individual goals of patients with Failed Back Surgery Syndrome, who will be treated with spinal cord stimulation.
Interventions
OTHERinterview regarding goals
interview regarding goals
Sponsors
Medtronic
Moens Maarten
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Chronic pain as a result of FBSS that exists for at least 6 months with a pain intensity 5 or higher measured on numeric rating scale (NRS) * FBSS patients suitable for SCS * Age \> 18 years * Native Dutch or French speeking patients
Exclusion criteria
* Expected inability of patients to receive or properly operate the spinal cord stimulation system * History of coagulation disorders, lupus erythematosus, diabetic neuropathy, rheumatoid arthritis or morbus Bechterew * Active malignancy * Addiction to any of the following drugs, alcohol (5E/day) and/or medication * Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by investigator * Immune deficiency (HIV positive, immunosuppressiva, etc.) * Life expectancy \< 1 year * Local infection or other skin disorder at site of incision * Pregnancy * Other implanted active medical device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Goals and expectations towards spinal cord stimulation | Before spinal cord stimulation implantation | Individual goals and expectations regarding the treatment with spinal cord stimulation will be explored during an interview |
Countries
Belgium
Outcome results
None listed