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

Medtronic

Status: Completed

Conditions: Chronic Pain Syndrome

Study type: Observational

Funder types: Industry

Identifiers

NCT01778426

1051

Details and patient eligibility

About

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.

Enrollment: 414 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

414 participants in 1 patient group

Patients with Medtronic neurostimulator

Description:

Patients suffering from chronic neuropathic pain syndrome implanted (first implant or replacements) with a Medtronic neurostimulator.