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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain Syndrome

• Study Type: Observational
• Enrollment (Actual): 414

Contacts and Locations

Study Locations

• France
  • Suresnes, France, 92151
    • Hôpital Foch - 40 rue Worth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients implanted (first implant or replacements) with a Medtronic neurostimulator in selected French sites .

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects With at Least 50% Pain Relief in the Area of Predominant Pain at 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).	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects With at Least 50% Pain Relief in the Area of Non-predominant Pain	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).	1 year and 2 years
Percentage of Subjects With at Least 50% Pain Relief in the Area of Predominant Pain at 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).	1 year
Concomitant Pain Relief Medication	Percentage of primo-implanted subjects taking pain relief medication at baseline, 1 and 2 years.	Baseline, 1 and 2 years
Dose of Analgesics Level 3 (Morphinics)	Dose of analgesics level 3 (morphinics) summarized as equivalent morphine dose at baseline, 1 and 2 years.	Baseline, 1 and 2 years
Patient Satisfaction	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").	1 and 2 years
Return to Work	Percentage of subjects being invalid at inclusion and active at 1 and 2 years.	1 and 2 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: January 24, 2013
• First Submitted That Met QC Criteria: January 24, 2013
• First Posted (Estimate): January 29, 2013

Study Record Updates

• Last Update Posted (Actual): November 29, 2018
• Last Update Submitted That Met QC Criteria: May 11, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Spinal Cord Stimulation; Chronic neuropathic pain syndrome; Painstim devices
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 1051