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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
Results First Posted : November 29, 2018
Last Update Posted : November 29, 2018
Sponsor:
Collaborator:
Medtronic Bakken Research Center
Information provided by (Responsible Party):
MedtronicNeuro

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 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
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

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



Primary Outcome Measures :
  1. Percentage of Subjects With at Least 50% Pain Relief in the Area of Predominant Pain at 2 Years [ Time Frame: 2 years ]
    Percentage of primo-implanted subjects who responded to the treatment, where response was defined as a pain relief of at least 50% in the area with predominant pain intensity from baseline to two years follow-up. Pain intensity was assessed using an 11-point (0-10) Numeric Pain Rating Scale (NPRS) ranging from 0 (no pain) to 10 (maximum pain possible).


Secondary Outcome Measures :
  1. Percentage of Subjects With at Least 50% Pain Relief in the Area of Non-predominant Pain [ Time Frame: 1 year and 2 years ]
    Percentage of primo-implanted subjects who responded to the treatment, where response was defined as a pain relief of at least 50% in the area with non-predominant pain intensity at 1 and 2 years follow-up, compared to baseline. Pain intensity was assessed using an 11-point (0-10) Numeric Pain Rating Scale (NPRS) ranging from 0 (no pain) to 10 (maximum pain possible).

  2. Percentage of Subjects With at Least 50% Pain Relief in the Area of Predominant Pain at 1 Year [ Time Frame: 1 year ]
    Percentage of primo-implanted subjects who responded to the treatment, where response was defined as a pain relief of at least 50% in the area with predominant pain intensity from baseline to one year follow-up. Pain intensity was assessed using an 11-point (0-10) Numeric Pain Rating Scale (NPRS) ranging from 0 (no pain) to 10 (maximum pain possible).

  3. Concomitant Pain Relief Medication [ Time Frame: Baseline, 1 and 2 years ]
    Percentage of primo-implanted subjects taking pain relief medication at baseline, 1 and 2 years.

  4. Dose of Analgesics Level 3 (Morphinics) [ Time Frame: Baseline, 1 and 2 years ]
    Dose of analgesics level 3 (morphinics) summarized as equivalent morphine dose at baseline, 1 and 2 years.

  5. Patient Satisfaction [ Time Frame: 1 and 2 years ]
    Percentage of primo-implanted subjects satisfied with the treatment 1 and 2 years after implantation (defined as indicating "pain relief improvement," "daily life improvement," "rather satisfied with the treatment," or "would agree to the treatment again").

  6. Return to Work [ Time Frame: 1 and 2 years ]
    Percentage of subjects being invalid at inclusion and active at 1 and 2 years.



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Ages Eligible for Study:   Child, Adult, Older Adult
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

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
MedtronicNeuro
Medtronic Bakken Research Center
Investigators
Study Chair: Marie-Christine DJIAN, MD Hôpital Saint Anne, Paris

Additional Information:

Responsible Party: MedtronicNeuro
ClinicalTrials.gov Identifier: NCT01778426     History of Changes
Other Study ID Numbers: 1051
First Posted: January 29, 2013    Key Record Dates
Results First Posted: November 29, 2018
Last Update Posted: November 29, 2018
Last Verified: May 2018

Keywords provided by MedtronicNeuro:
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