Failed Back Surgery Syndrome
Conditions
Keywords
High density spinal cord stimulation, Virtual expert registry
Brief summary
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
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.
Interventions
DEVICEspinal cord stimulation
Sponsors
Medtronic
Universitair Ziekenhuis Brussel
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient's satisfaction | The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months. | Patient's satisfaction with the stimulation will be assessed with a 5 item Likert scale |
| 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 | The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months. | Questionnaire regarding the amount of pain relief by pain medication |
| The abilities in daily living | The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months. | The functional abilities will be assessed with the Oswestry Low Back Pain Questionnaire. |
| The current health status | The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months. | The health status will be observed with the Euroqol (EQ-5D-5L) questionnaire. |
| Subjective sleep quality | The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months. | Subjective sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain area coverage | The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months. | The patient has to draw the areas of pain coverage on a body shape figure |
| Paresthesia threshold | The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months. | Patient indicates the threshold at which he experiences paresthesia |
| HD stim parameters | The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months. | Questionnaire towards the clinician regarding the ideal high density parameters for this patient |
| Battery efficiency of the neurostimulator | The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months. | The battery usage will be measured by frequencies to recharge the battery. |
| AdaptiveStim use (in case of Restore Sensor) | The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months. | Acquire information on activity from the internal diary; amount of times that patients need to fit the ideal parameters themselves |
| MRI need | The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months. | Questionnaire regarding the need for MR scans for other medical conditions |
Countries
Belgium
Outcome results
None listed