High-density in Spinal Cord Stimulation: Virtual Expert Registry

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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High-density in Spinal Cord Stimulation: Virtual Expert Registry

Conditions
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Failed Back Surgery Syndrome

Intervention / Treatment
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* Device: spinal cord stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Failed Back Surgery Syndrome patients (FBSS) with insufficient pain reduction with conventional SCS or FBSS patients suitable for SCS Age > 18 years 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) Patient has been informed of the study procedures and has given written informed consent Patient willing to comply with study protocol including attending the study visits 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| spinal cord stimulation<br>Failed back surgery syndrome patients will receive high density spinal cord stimulation | Device: spinal cord stimulation<br> <br> * Other names: high density spinal cord stimulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity with the Numeric Rating Scale (NRS) |  | 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 | 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. | 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. | 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). | 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 | The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain area coverage | The patient has to draw the areas of pain coverage on a body shape figure | 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 | 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 | 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. | 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 | 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 | The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High density spinal cord stimulation, Virtual expert registry