Follow-up of Post-spinal Implantable Neurostimulator PRECISION®

Completed

• Conditions: Chronic Refractory Neuropathic Pain; Ischemic Peripheral Pain
• Interventions: Device: Neurostimulator Precision

• Registration Number: NCT02208999
• Lead Sponsor: Cemka-Eval

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

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-08-01
• Study First Submitted QC: 2014-08-01
• Study First Posted: 2014-08-05
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Results First Submitted: 2019-06-14
• Status Verified: 2019-11
• Results First Submitted QC: 2019-11-05
• Last Update Submitted: 2019-11-05
• Results First Posted: 2019-11-06
• Last Update Posted: 2019-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neurostimulator Precision	Neurostimulator Precision	Patients implanted or reimplanted with the neurostimulator Precision

Primary Outcome Measures

Name	Time	Method
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.	From baseline until the end of the study at 24 months.	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.
Average Pain Score Over the Last 8 Days, Evaluated by Numerical Scale at 1 Year, and at 2 Years.	From baseline until the end of the study at 24 months.	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Implanted Patients (de Novo Implants) With an Improvement of at Least 30% of the Overall Average Pain, Evaluated by Numerical Scale	From baseline until the end of the study at 24 months	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
Patients' Opinion on the Evolution of Pain	From baseline until the end of the study at 24 months	- Pain relief compared to what the patient with a de novo implant, felt before the implantation at 12 months and at 24 months.
Evolution of Quality of Life (SF-12) - Physical Score	From baseline until the end of the study at 24 months	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.
Percentage of Patients With Anxiety and Depression Disorders	From baseline until the end of the study at 24 months	Evolution of the rate of patients with anxiety and depression disorders at12 and 24 months.
Patients' Willingness to Restart the Treatment	From baseline until the end of the study at 24 months	Patients' willingness to restart the treatment at 12 months and at 24 months.
Evolution of Quality of Life (SF-12) - Mental Score	From baseline until the end of the study at 24 months	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.
Evolution of the Use of Level 3 Analgesics	From baseline until the end of the study at 24 months	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
Evolution of the Use of Other Pain Treatments	From baseline until the end of the study at 24 months	Rate of primary implanted patients who took at least one analgesic treatment at each follow-up (at 1 year and at 2 years)

Trial Locations

Locations (1)

Hospitals implanting the neurostimulator Precision; 🇫🇷 Multiple Locations, France