Clinical trial NCT02208999: Follow-up of Post-spinal Implantable Neurostimulator PRECISION®
Official title: Two-years Follow-up of Post-spinal Implantable Neurostimulator PRECISION®
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Refractory Neuropathic Pain
Ischemic Peripheral Pain
Keywords: medullary neurostimulation
pain
Precision
rechargeable
implantable
Lead sponsor: Cemka-Eval
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2014-08-05
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All implanted patients (primary implementation and reimplantation) with the neurostimulator PRECISION ®, during the inclusion period (1 year).

Brief summary: Assessing the long-term efficacy, complications, revision rates and final explantation of the device

Detailed description: 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

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

Primary outcomes:
measure: 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.
timeFrame: From baseline until the end of the study at 24 months.
measure: Average Pain Score Over the Last 8 Days, Evaluated by Numerical Scale at 1 Year, and at 2 Years.
timeFrame: From baseline until the end of the study at 24 months.
Secondary outcomes:
measure: Percentage of Implanted Patients (de Novo Implants) With an Improvement of at Least 30% of the Overall Average Pain, Evaluated by Numerical Scale
timeFrame: From baseline until the end of the study at 24 months
measure: Patients' Opinion on the Evolution of Pain
timeFrame: From baseline until the end of the study at 24 months
measure: Evolution of the Use of Other Pain Treatments
timeFrame: From baseline until the end of the study at 24 months
measure: Evolution of Quality of Life (SF-12) - Physical Score
timeFrame: From baseline until the end of the study at 24 months
measure: Patients' Willingness to Restart the Treatment
timeFrame: From baseline until the end of the study at 24 months
measure: Percentage of Patients With Anxiety and Depression Disorders
timeFrame: From baseline until the end of the study at 24 months
measure: Evolution of Quality of Life (SF-12) - Mental Score
timeFrame: From baseline until the end of the study at 24 months
measure: Evolution of the Use of Level 3 Analgesics
timeFrame: From baseline until the end of the study at 24 months
Other outcomes:
Locations:
city: Multiple Locations
country: France
facility: Hospitals implanting the neurostimulator Precision
Study officials:
affiliation: Boston Scientific Corporation
name: Elisabeth Dr Mouton, MD
role: STUDY_DIRECTOR
References: