Assessing the long-term efficacy, complications, revision rates and final explantation of the device
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 Type
OBSERVATIONAL
Enrollment
106
All patients included must have been implanted with the neurostimulator Precision
Hospitals implanting the neurostimulator Precision
Multiple Locations, France
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.
Time frame: 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.
Time frame: 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% 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
Time frame: 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.
Time frame: 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)
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: From baseline until the end of the study at 24 months