Phase
Condition
N/ATreatment
Spinal Cord Stimulation
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients with severe chronic pain (> 5 on numeric rating scale, NRS) for at least 6months due to FBSS (PSPS T2) and suitable for treatment with DTM SCS according tothe treating physician
Age > 18 years
Patient has been informed of the study procedures and has given written informedconsent
Patient willing to comply with study protocol including attending the study visits
Exclusion
Exclusion Criteria:
Expected inability of the patient to receive or properly operate the spinal cordstimulation system
History of coagulation disorder, lupus erythematosus, diabetic neuropathy,rheumatoid arthritis, or morbus Bechterew
Active malignancy
Addiction to drugs, alcohol (>5 units per day) and/or medication
Evidence of an active disruptive psychiatric disorder or other known condition thatmay impact perception of pain, compliance to the intervention, and/or ability toevaluate treatment outcome as determined by investigator
Immune deficiency (e.g. HIV positive, immunosuppressive treatment)
Life expectancy < 1 year
Local infection or any other skin disorder at site of incision
Pregnancy
Other implanted active medical device
Study Design
Connect with a study center
Universitair Ziekenhuis Brussel
Jette, Brussel 1090
BelgiumActive - Recruiting
ZNA
Antwerpen,
BelgiumActive - Recruiting
AZ Sint-Jan Brugge-Oostende
Brugge,
BelgiumActive - Recruiting
AZ Sint-Lucas Brugge
Brugge,
BelgiumActive - Recruiting
Jessa Ziekenhuis
Hasselt,
BelgiumActive - Recruiting
AZ Groeninge
Kortrijk,
BelgiumActive - Recruiting
UZ Leuven
Leuven,
BelgiumActive - Recruiting
Heilig Hart Ziekenhuis Lier
Lier,
BelgiumActive - Recruiting
Centre Hospitalier Régional (CHR) de la Citadelle
Liège,
BelgiumActive - Recruiting
AZ Sint-Maarten
Mechelen,
BelgiumActive - Recruiting
AZ Delta
Roeselare,
BelgiumActive - Recruiting
Vitaz
Sint-Niklaas,
BelgiumActive - Recruiting
AZ Turnhout
Turnhout,
BelgiumActive - Recruiting
GZA
Wilrijk,
BelgiumActive - Recruiting
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