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

MedtronicNeuro414 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

414

Conditions

Chronic Pain Syndrome

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Hôpital Foch - 40 rue Worth

Suresnes, France

Outcomes

Primary Outcomes

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).

Time frame: 2 years

Secondary Outcomes

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).

Time frame: 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).

Time frame: 1 year

Concomitant Pain Relief Medication

Percentage of primo-implanted subjects taking pain relief medication at baseline, 1 and 2 years.

Time frame: 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.

Data from ClinicalTrials.gov

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