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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01778426
First Posted: January 29, 2013
Last Update Posted: September 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medtronic Bakken Research Center
Information provided by (Responsible Party):
Medtronic International Trading Sarl
January 24, 2013
January 29, 2013
September 23, 2016
January 2012
June 2016   (Final data collection date for primary outcome measure)
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
PainStim Efficacy [ Time Frame: 2 years ]
Evaluate the percentage of patients with 50% decrease in the VAS (Visual Analogic Scale) score over 2 years following SCS implant in first implant patients
Complete list of historical versions of study NCT01778426 on ClinicalTrials.gov Archive Site
Safety [ Time Frame: 2 years ]
Report all adverse device effects and procedure related adverse events over 2 years following SCS implant.
Same as current
Not Provided
Not Provided
 
Post-reimbursement Study to Follow Spinal Neurostimulator Devices for Pain Therapy (French SCS Registry)
Post-reimbursement Study to Follow Spinal Neurostimulator Devices for Pain Therapy

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.

Not Provided
Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
2 Years
Not Provided
Non-Probability Sample
All patients implanted (first implant or replacements) with a Medtronic neurostimulator in selected French sites .
Chronic Pain Syndrome
Not Provided
Patients with Medtronic neurostimulator
Patients suffering from chronic neuropathic pain syndrome implanted (first implant or replacements) with a Medtronic neurostimulator.
Not Provided
 
Completed
414
June 2016
June 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01778426
1051
No
Not Provided
Not Provided
Medtronic International Trading Sarl
Medtronic International Trading Sarl
Medtronic Bakken Research Center
Study Chair: Marie-Christine DJIAN, MD Hôpital Saint Anne, Paris
Medtronic International Trading Sarl
September 2016
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