This is a prospective, multi-center, observational follow-up study observing the effectiveness of high density spinal cord stimulation in patients with failed back surgery syndrome patients with back and leg pain.
DISCOVER will measure the effectiveness of high-density spinal cord stimulation for treatment of chronic back and leg pain. Identification of clinical effective parameters concerning location of active electrodes, frequency, pulse duration, amplitude and battery consumption are, besides safety, the major outcome parameters of this study.
Study Type
OBSERVATIONAL
Enrollment
272
UZ Brussel
Brussels, Belgium
Pain intensity with the Numeric Rating Scale (NRS)
Time frame: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
Pain relief by pain medication
Questionnaire regarding the amount of pain relief by pain medication
Time frame: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
The abilities in daily living
The functional abilities will be assessed with the Oswestry Low Back Pain Questionnaire.
Time frame: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
The current health status
The health status will be observed with the Euroqol (EQ-5D-5L) questionnaire.
Time frame: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
Subjective sleep quality
Subjective sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI).
Time frame: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
Patient's satisfaction
Patient's satisfaction with the stimulation will be assessed with a 5 item Likert scale
Time frame: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
Pain area coverage
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The patient has to draw the areas of pain coverage on a body shape figure
Time frame: The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
Paresthesia threshold
Patient indicates the threshold at which he experiences paresthesia
Time frame: The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
HD stim parameters
Questionnaire towards the clinician regarding the ideal high density parameters for this patient
Time frame: The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
Battery efficiency of the neurostimulator
The battery usage will be measured by frequencies to recharge the battery.
Time frame: The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
AdaptiveStim use (in case of Restore Sensor)
Acquire information on activity from the internal diary; amount of times that patients need to fit the ideal parameters themselves
Time frame: The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
MRI need
Questionnaire regarding the need for MR scans for other medical conditions
Time frame: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.