Post-reimbursement Study to Follow Spinal Neurostimulator Devices for Pain Therapy (French SCS Registry)

Study Overview
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Brief Summary
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Observational study to evaluate the long term efficacy of Spinal Cord Stimulation (SCS) over 2 years following SCS implant. This study is requested by French Health Authorities for reimbursement renewal, to maintain reimbursement for SCS in approved indication in France.

Official Title
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Post-reimbursement Study to Follow Spinal Neurostimulator Devices for Pain Therapy

Conditions
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Chronic Pain Syndrome

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient indicated for Spinal Cord Stimulation (pain therapy) Patient implanted for less than 3 months or hospitalized for the implant of a Medtronic neurostimulator including: primary implant with Spinal Cord Stimulation indication and positive test of stimulation or device replacement of a Medtronic neurostimulator used for Pain Therapy Evaluation of usual pain in the back, upper and lower limbs using a visual analogic scale must be available for the 3 days preceding implant. Treatments must also be available Patient read and signed the data release form Exclusion Criteria: Patient declined participation Patient is not available for follow up Stimulation of other body part than spinal
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 |
| --- | --- |
| Patients with Medtronic neurostimulator<br>Patients suffering from chronic neuropathic pain syndrome implanted (first implant or replacements) with a Medtronic neurostimulator. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With at Least 50% Pain Relief in the Area of Predominant Pain at 2 Years | Percentage of primo-implanted subjects who responded to the treatment, where response was defined as a pain relief of at least 50% in the area with predominant pain intensity from baseline to two years follow-up. Pain intensity was assessed using an 11-point (0-10) Numeric Pain Rating Scale (NPRS) ranging from 0 (no pain) to 10 (maximum pain possible). | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With at Least 50% Pain Relief in the Area of Non-predominant Pain | Percentage of primo-implanted subjects who responded to the treatment, where response was defined as a pain relief of at least 50% in the area with non-predominant pain intensity at 1 and 2 years follow-up, compared to baseline. Pain intensity was assessed using an 11-point (0-10) Numeric Pain Rating Scale (NPRS) ranging from 0 (no pain) to 10 (maximum pain possible). | 1 year and 2 years | 
| Percentage of Subjects With at Least 50% Pain Relief in the Area of Predominant Pain at 1 Year | Percentage of primo-implanted subjects who responded to the treatment, where response was defined as a pain relief of at least 50% in the area with predominant pain intensity from baseline to one year follow-up. Pain intensity was assessed using an 11-point (0-10) Numeric Pain Rating Scale (NPRS) ranging from 0 (no pain) to 10 (maximum pain possible). | 1 year | 
| Concomitant Pain Relief Medication | Percentage of primo-implanted subjects taking pain relief medication at baseline, 1 and 2 years. | Baseline, 1 and 2 years | 
| Dose of Analgesics Level 3 (Morphinics) | Dose of analgesics level 3 (morphinics) summarized as equivalent morphine dose at baseline, 1 and 2 years. | Baseline, 1 and 2 years | 
| Patient Satisfaction | Percentage of primo-implanted subjects satisfied with the treatment 1 and 2 years after implantation (defined as indicating pain relief improvement, daily life improvement, rather satisfied with the treatment, or would agree to the treatment again). | 1 and 2 years | 
| Return to Work | Percentage of subjects being invalid at inclusion and active at 1 and 2 years. | 1 and 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic neuropathic pain syndrome, Spinal Cord Stimulation, Painstim devices, Efficacy, Safety