N/A
Completed N=402
Post-reimbursement Study to Follow Spinal Neurostimulator Devices for Pain Therapy (French SCS Registry)
Chronic Pain Syndrome
Source: ClinicalTrials.gov NCT01778426 ↗
Enrolled (actual)
402
Serious AEs
22.1%
Results posted
Nov 2018
Primary outcomePrimary: Percentage of Subjects With at Least 50% Pain Relief in the Area of Predominant Pain at 2 Years — 59.1 Percentage of responders
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With at Least 50% Pain Relief in the Area of Predominant Pain at 2 Years |
59.1 | — |
| SECONDARY Percentage of Subjects With at Least 50% Pain Relief in the Area of Non-predominant Pain |
46.9; 46.5 | — |
| SECONDARY Percentage of Subjects With at Least 50% Pain Relief in the Area of Predominant Pain at 1 Year |
60.7 | — |
| SECONDARY Concomitant Pain Relief Medication |
59.1; 43.3; 43.9; 61.1; 35.4; 36.4 | — |
| SECONDARY Dose of Analgesics Level 3 (Morphinics) |
90.2; 102.6; 100.3 | — |
| SECONDARY Patient Satisfaction |
89.9; 89.3; 82.0; 81.8; 89.9; 91.4 | — |
| SECONDARY Return to Work |
8; 15 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01778426). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.