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

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ClinicalTrials.gov Identifier: NCT01778426
Recruitment Status : Completed
First Posted : January 29, 2013
Last Update Posted : September 23, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease
Chronic Pain Syndrome

Study Design

Study Type : Observational [Patient Registry]
Actual Enrollment : 414 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Post-reimbursement Study to Follow Spinal Neurostimulator Devices for Pain Therapy
Study Start Date : January 2012
Primary Completion Date : June 2016
Study Completion Date : June 2016
Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Safety [ Time Frame: 2 years ]
    Report all adverse device effects and procedure related adverse events over 2 years following SCS implant.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients implanted (first implant or replacements) with a Medtronic neurostimulator in selected French sites .
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01778426


Locations
France
Hôpital Foch - 40 rue Worth
Suresnes, France, 92151
Sponsors and Collaborators
Medtronic International Trading Sarl
Medtronic Bakken Research Center
Investigators
Study Chair: Marie-Christine DJIAN, MD Hôpital Saint Anne, Paris
More Information

Responsible Party: Medtronic International Trading Sarl
ClinicalTrials.gov Identifier: NCT01778426     History of Changes
Other Study ID Numbers: 1051
First Posted: January 29, 2013    Key Record Dates
Last Update Posted: September 23, 2016
Last Verified: September 2016

Keywords provided by Medtronic International Trading Sarl:
Chronic neuropathic pain syndrome
Spinal Cord Stimulation
Painstim devices
Efficacy
Safety

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms