N/A
N=106
Follow-up of Post-spinal Implantable Neurostimulator PRECISION®
Chronic Refractory Neuropathic Pain · Ischemic Peripheral Pain
Bottom Line
View on ClinicalTrials.gov: NCT02208999 ↗Enrolled (actual)
106
Serious AEs
21.7%
Results posted
Nov 2019
Primary outcome: Primary: Percentage of Implanted Patients (de Novo Implants) With an Improvement of at Least 50% of the Overall Average Pain Over the Last 8 Days, Evaluated by Numerical Scale at the First Follow-up Visit, at 1 Year, and 2 Years. — 34.5; 35.7 percentage of patients
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Neurostimulator Precision (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cemka-Eval
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Implanted Patients (de Novo Implants) With an Improvement of at Least 50% of the Overall Average Pain Over the Last 8 Days, Evaluated by Numerical Scale at the First Follow-up Visit, at 1 Year, and 2 Years. |
34.5; 35.7 | — |
| PRIMARY Average Pain Score Over the Last 8 Days, Evaluated by Numerical Scale at 1 Year, and at 2 Years. |
4.5; 4.9 | — |
| SECONDARY Percentage of Implanted Patients (de Novo Implants) With an Improvement of at Least 30% of the Overall Average Pain, Evaluated by Numerical Scale |
53.7; 53.6; 54.5; 51.4; 46.3; 40.6 | — |
| SECONDARY Patients' Opinion on the Evolution of Pain |
49; 55 | — |
| SECONDARY Evolution of the Use of Other Pain Treatments |
42; 54 | — |
| SECONDARY Evolution of Quality of Life (SF-12) - Physical Score |
30; 38 | — |
| SECONDARY Patients' Willingness to Restart the Treatment |
45; 57 | — |
| SECONDARY Percentage of Patients With Anxiety and Depression Disorders |
38.9; 45.6 | — |
| SECONDARY Evolution of Quality of Life (SF-12) - Mental Score |
16; 17 | — |
| SECONDARY Evolution of the Use of Level 3 Analgesics |
67.9; 55.6 | — |
Summary
Assessing the long-term efficacy, complications, revision rates and final explantation of the device
Eligibility Criteria
Inclusion Criteria
- Adult patient receiving spinal implantation of a neurostimulator PRECISION ® ( primary implantation or reimplantation)
Exclusion Criteria
- Refusal of patient
- Patient whose long-term monitoring will not be possible
Data sourced from ClinicalTrials.gov (NCT02208999). 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.