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

Completed

Conditions: Chronic Pain Syndrome

Registration Number: NCT01778426

Lead Sponsor: MedtronicNeuro

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 414

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With at Least 50% Pain Relief in the Area of Predominant Pain at 2 Years	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).

Secondary Outcome Measures

Name	Time	Method
Dose of Analgesics Level 3 (Morphinics)	Baseline, 1 and 2 years	Dose of analgesics level 3 (morphinics) summarized as equivalent morphine dose at baseline, 1 and 2 years.
Return to Work	1 and 2 years	Percentage of subjects being invalid at inclusion and active at 1 and 2 years.
Percentage of Subjects With at Least 50% Pain Relief in the Area of Predominant Pain at 1 Year	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).
Patient Satisfaction	1 and 2 years	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").
Percentage of Subjects With at Least 50% Pain Relief in the Area of Non-predominant Pain	1 year and 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 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).
Concomitant Pain Relief Medication	Baseline, 1 and 2 years	Percentage of primo-implanted subjects taking pain relief medication at baseline, 1 and 2 years.