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

This study has been completed.
Medtronic Bakken Research Center
Information provided by (Responsible Party):
Medtronic International Trading Sarl Identifier:
First received: January 24, 2013
Last updated: September 22, 2016
Last verified: September 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.

Chronic Pain Syndrome

Study Type: Observational [Patient Registry]
Study Design: 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

Further study details as provided by Medtronic International Trading Sarl:

Primary Outcome Measures:
  • PainStim Efficacy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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:
  • Safety [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Report all adverse device effects and procedure related adverse events over 2 years following SCS implant.

Enrollment: 414
Study Start Date: January 2012
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Patients with Medtronic neurostimulator
Patients suffering from chronic neuropathic pain syndrome implanted (first implant or replacements) with a Medtronic neurostimulator.


Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
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 .

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01778426

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

Responsible Party: Medtronic International Trading Sarl Identifier: NCT01778426     History of Changes
Other Study ID Numbers: 1051 
Study First Received: January 24, 2013
Last Updated: September 22, 2016
Health Authority: France: The Commission nationale de l’informatique et des libertés
France: Haute Autorité de Santé Transparency Commission
France: Conseil National de l'Ordre des Médecins

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

Additional relevant MeSH terms:
Chronic Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms processed this record on December 07, 2016