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OpenTrials
Completed

NCT Number: NCT02208999

Follow-up of Post-spinal Implantable Neurostimulator PRECISION®

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

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Key information

Conditions

Chronic Refractory Neuropathic Pain Ischemic Peripheral Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospitals implanting the neurostimulator Precision

Multiple Locations, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neurostimulator Precision

Device

All patients included must have been implanted with the neurostimulator Precision

Primary outcomes

  1. 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.

    Time frame: 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.

  2. Average Pain Score Over the Last 8 Days, Evaluated by Numerical Scale at 1 Year, and at 2 Years.

    Time frame: 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 outcomes

  1. Percentage of Implanted Patients (de Novo Implants) With an Improvement of at Least 30% of the Overall Average Pain, Evaluated by Numerical Scale

    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% 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

  2. Patients' Opinion on the Evolution of Pain

    Time frame: 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.

  3. Evolution of the Use of Other Pain Treatments

    Time frame: 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)

  4. Evolution of Quality of Life (SF-12) - Physical Score

    Time frame: 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.

  5. Patients' Willingness to Restart the Treatment

    Time frame: From baseline until the end of the study at 24 months

    Patients' willingness to restart the treatment at 12 months and at 24 months.

  6. Percentage of Patients With Anxiety and Depression Disorders

    Time frame: 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.

  7. Evolution of Quality of Life (SF-12) - Mental Score

    Time frame: 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.

  8. Evolution of the Use of Level 3 Analgesics

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Cemka-Eval

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Official study title

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

Acronym: PRECISION

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Aug 5, 2014
Registry last updated
Nov 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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