Status:
COMPLETED
Goal Setting in SCS Patients: a Qualitative Review
Lead Sponsor:
Moens Maarten
Collaborating Sponsors:
Medtronic
Conditions:
Failed Back Surgery Syndrome
Eligibility:
All Genders
18+ years
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2019
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03761316
Start Date
December 1 2018
End Date
March 31 2019
Last Update
April 17 2019
Active Locations (1)
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1
UZ Brussel
Jette, Brussels Capital, Belgium, 1090