Chronic Refractory Neuropathic PainPRECISIONNCT02208999
Follow-up of Post-spinal Implantable Neurostimulator PRECISION®
An observational study of Chronic Refractory Neuropathic Pain and Ischemic Peripheral Pain, run by Cemka-Eval at 1 site in France.
Trial summary
Assessing the long-term efficacy, complications, revision rates and final explantation of the device Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Refractory Neuropathic Pain, Ischemic Peripheral Pain
- What is being tested?
- Neurostimulator Precision
- Type of treatment
- Medical device
- How many people
- 106 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2013to Dec 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All implanted patients (primary implementation and reimplantation) with the neurostimulator PRECISION ®, during the inclusion period (1 year).
Who may be able to join
- Adult patient receiving spinal implantation of a neurostimulator PRECISION ® ( primary implantation or reimplantation)
Who cannot join
- Refusal of patient
- Patient whose long-term monitoring will not be possible
Trial locations and contacts
1 site in 1 country.
France1 site
Hospitals implanting the neurostimulator Precision
Multiple Locations
About this study
Official title: Two-years Follow-up of Post-spinal Implantable Neurostimulator PRECISION®
Assessing the long-term efficacy, complications, revision rates and final explantation of the device
Read the 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
- Being tested
- Neurostimulator Precision
- Keywords
- medullary neurostimulation, pain, Precision, rechargeable, implantable
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurostimulator PrecisionDevice
All patients included must have been implanted with the neurostimulator Precision
| Study group | Role | What they receive |
|---|---|---|
| Neurostimulator Precision | Patients implanted or reimplanted with the neurostimulator Precision Receives: Device: Neurostimulator Precision |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From baseline until the end of the study at 24 months.
Secondary outcomes (8)
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
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: From baseline until the end of the study at 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2014 (estimated)
- Study startDec 2013
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Refractory Neuropathic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cemka-Eval
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Elisabeth Dr Mouton, MD, Study director, Boston Scientific Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02208999
- Sponsor's protocol ID
- 2011045
- Other IDs
- 913018
- Acronym
- PRECISION
- Status last verified
- Nov 2019
- First submitted
- 1 Aug 2014
- Last updated
- 6 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- Individual data sharing
- No: Individual participant data will not be shared; Only aggregated data will be communicated
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-years Follow-up of Post-spinal Implantable Neurostimulator PRECISION®
- ClinicalTrials.gov ID
- NCT02208999
- Acronym / sponsor ID
- PRECISION / 2011045
- Keywords
- medullary neurostimulation, pain, Precision, rechargeable, implantable
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Cemka-EvalUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- Dec 2013 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 5 Aug 2014 (estimated)
- Results
- Posted 6 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurostimulator Precision | – | Device: Neurostimulator PrecisionPatients implanted or reimplanted with the neurostimulator Precision |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All implanted patients (primary implementation and reimplantation) with the neurostimulator PRECISION ®, during the inclusion period (1 year).
Key inclusion criteria (1 listed)
- Adult patient receiving spinal implantation of a neurostimulator PRECISION ® ( primary implantation or reimplantation)
Key exclusion criteria (2 listed)
- Refusal of patient
- Patient whose long-term monitoring will not be possible
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurostimulator PrecisionAll patients included must have been implanted with the neurostimulator Precision | Device | Neurostimulator Precision |
Primary outcome
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.
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.
8 secondary outcomes
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
Patients' Opinion on the Evolution of Pain
Time frame: From baseline until the end of the study at 24 months
Evolution of the Use of Other Pain Treatments
Time frame: From baseline until the end of the study at 24 months
Evolution of Quality of Life (SF-12) - Physical Score
Time frame: From baseline until the end of the study at 24 months
Patients' Willingness to Restart the Treatment
Time frame: From baseline until the end of the study at 24 months
Percentage of Patients With Anxiety and Depression Disorders
Time frame: From baseline until the end of the study at 24 months
Evolution of Quality of Life (SF-12) - Mental Score
Time frame: From baseline until the end of the study at 24 months
Evolution of the Use of Level 3 Analgesics
Time frame: From baseline until the end of the study at 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Individual participant data will not be shared; Only aggregated data will be communicated
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth Dr Mouton, MD study director
Boston Scientific Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Refractory Neuropathic Pain and Ischemic Peripheral Pain, run by Cemka-Eval at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: From baseline until the end of the study at 24 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2019.