Post-reimbursement Study to Follow Spinal Neurostimulator Devices for Pain Therapy (French SCS Registry) (SME)
|ClinicalTrials.gov Identifier: NCT01778426|
Recruitment Status : Completed
First Posted : January 29, 2013
Last Update Posted : September 23, 2016
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.
|Condition or disease|
|Chronic Pain Syndrome|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||414 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||Post-reimbursement Study to Follow Spinal Neurostimulator Devices for Pain Therapy|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
Patients with Medtronic neurostimulator
Patients suffering from chronic neuropathic pain syndrome implanted (first implant or replacements) with a Medtronic neurostimulator.
- PainStim Efficacy [ Time Frame: 2 years ]Evaluate the percentage of patients with 50% decrease in the NPRS (Numeric Pain Rating Scale) score of the predominant pain over 2 years following SCS implant in first implant patients
- Safety [ Time Frame: 2 years ]Report all adverse device effects and procedure related adverse events over 2 years following SCS implant.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01778426
|Hôpital Foch - 40 rue Worth|
|Suresnes, France, 92151|
|Study Chair:||Marie-Christine DJIAN, MD||Hôpital Saint Anne, Paris|