Follow-up of Post-spinal Implantable Neurostimulator PRECISION®

Study Overview
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Brief Summary
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Assessing the long-term efficacy, complications, revision rates and final explantation of the device

Detailed Description
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Longitudinal study with a follow-up of 2 years in patients implanted with the Precision neurostimulator. This study will describe the characterisrics of the patients, of the implantation and will assess the long-term efficacy, complications, revision rates and final explantation of the device

Official Title
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Two-years Follow-up of Post-spinal Implantable Neurostimulator PRECISION®

Conditions
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Chronic Refractory Neuropathic Pain, Ischemic Peripheral Pain

Intervention / Treatment
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* Device: Neurostimulator Precision


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Neurostimulator Precision<br>Patients implanted or reimplanted with the neurostimulator Precision | Device: Neurostimulator Precision<br>* All patients included must have been implanted with the neurostimulator Precision<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Percentage of patients (de novo implants) having a reduction of usual pain over the past 8 days of at least 50% at 12 and 24 months. The pain was measured with a numerical scale from 0 to 10 (0 = no pain and 10 = most intense pain). This data has been provided by 71 patients at 1 year and by 70 patients at 2 years. | From baseline until the end of the study at 24 months. | 
| Average Pain Score Over the Last 8 Days, Evaluated by Numerical Scale at 1 Year, and at 2 Years. | The pain was evaluated with a numerical scale from 0 to 10. 0 = no pain and 10 = most intense pain. This data has been provided by 71 patients at 1 year and by 70 patients at 2 years. | From baseline until the end of the study at 24 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Implanted Patients (de Novo Implants) With an Improvement of at Least 30% of the Overall Average Pain, Evaluated by Numerical Scale | Percentage of implanted patients (de novo implants) with an improvement of at least 30% at 12 and 24 months after inclusion for: pain at the present time usual pain over the past 8 days the most severe pain in the last 8 days | From baseline until the end of the study at 24 months | 
| Patients' Opinion on the Evolution of Pain | - Pain relief compared to what the patient with a de novo implant, felt before the implantation at 12 months and at 24 months. | From baseline until the end of the study at 24 months | 
| Evolution of the Use of Other Pain Treatments | Rate of primary implanted patients who took at least one analgesic treatment at each follow-up (at 1 year and at 2 years) | From baseline until the end of the study at 24 months | 
| Evolution of Quality of Life (SF-12) - Physical Score | Percentage of de novo patients with an increase of SF-12 (Short-Form health survey) physical score at 12 and 24 months. An increase of this score indicates an improvement in physical quality of life. | From baseline until the end of the study at 24 months | 
| Patients' Willingness to Restart the Treatment | Patients' willingness to restart the treatment at 12 months and at 24 months. | From baseline until the end of the study at 24 months | 
| Percentage of Patients With Anxiety and Depression Disorders | Evolution of the rate of patients with anxiety and depression disorders at12 and 24 months. | From baseline until the end of the study at 24 months | 
| Evolution of Quality of Life (SF-12) - Mental Score | Percentage of de novo patients with an increase of SF-12 (Short-Form health survey) mental score at 12 and 24 months. An increase of this score indicates an improvement in mental quality of life. | From baseline until the end of the study at 24 months | 
| Evolution of the Use of Level 3 Analgesics | Mean posology of level 3 analgesics at each follow-up (at 1 year and at 2 years). The posology was estimated in oral morphine equivalent dosage. At 1 year, 14 patients had a level 3 analgesic and at 2 years 18 patients had this type of analgesic. The posology was available for respectively 4 and 16 patients | From baseline until the end of the study at 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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medullary neurostimulation, pain, Precision, rechargeable, implantable