This study is an interventional, observatory single center trial investigating the functional connectivity of the electrical brain activity in high frequency/high density spinal cord stimulation in failed back surgery syndrome patients with back and leg pain.
Based on the reimbursement rules in Belgium, a trial implantation of 4 weeks is necessary before implanting the definitive neurostimulator. The definitive neurostimulator will be implanted minimum 4 weeks after the trial implantation, when the patient reports more than 50% pain reduction and/or more than 50% reduction in pain medication. Patients who are included in this study will have four extra study visits at the University Hospital Brussels. The first assessment will take place during the week prior to surgery, the second minimal one month after definitive implantation of the stimulator. The assessments consist of filling in the Pittsburgh Sleep Quality Index (PSQI) and the Pain Catastrophizing Scale (PCS) and recording brain activity before and during the pain protocol. Additionally, patients will wear an Actiwatch for measuring sleep patterns and fill in a VAS diary (back and leg pain separately), one month before the baseline assessment and one month before the second assessment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
UZ Brussel
Brussels, Vlaams Brabant, Belgium
Functional connectivity
EEG recordings to measure functional connectivity in the brain
Time frame: The change between baseline and 1 month after definitive implantation of the neurostimulator
Functioning of the descending inhibitory pathway
Functioning of the descending pathway will be measured with the conditioned pain modulation paradigm by using electrical stimulation and cold water
Time frame: The change between baseline and 1 month after definitive implantation of the neurostimulator
Visual Analogue Scale (VAS) pain diary
Time frame: Three times every day (morning, afternoon and evening), starting 1 month before baseline measurements up to the second measurement 1 month after definitive implantation of the neurostimulator (at study completion).
Objective sleep quality will be measured using the Actiwatch spectrum plus (Respironics).
This compact and lightweight electronic device similar in size to a wristwatch is worn on the non-dominant hand, and measures and records sleep quality
Time frame: The difference between 1 month before baseline measurements and 1 month before the second measurement (1 month after definitive implantation).
Pain Catastrophizing
Pain catastrophizing is assess be using the 'pain catastrophizing scale'.
Time frame: The change between baseline and 1 month after definitive implantation of the neurostimulator
Subjective sleep quality
Subjective sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI).
Time frame: The change between baseline and 1 month after definitive implantation of the neurostimulator
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