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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

414 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2016-06-30

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.

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Detailed Description

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Conditions

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Chronic Pain Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with Medtronic neurostimulator

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

No interventions assigned to this group

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