Follow-up of Post-spinal Implantable Neurostimulator PRECISION®

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02208999

Acronym

PRECISION

Enrollment

106

Registered

2014-08-05

Start date

2013-12-31

Completion date

2017-12-31

Last updated

2019-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Refractory Neuropathic Pain, Ischemic Peripheral Pain

Keywords

medullary neurostimulation, pain, Precision, rechargeable, implantable

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

Interventions

DEVICENeurostimulator Precision

All patients included must have been implanted with the neurostimulator Precision

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)
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.
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.
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
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
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' 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.

Countries

France

Participant flow

Recruitment details

Recruitment between December 3, 2015 and October 21, 2015 in 7 French clinical centers

Pre-assignment details

No pre-assignment details

Participants by arm

Arm	Count
Implanted Patients 91 patients de novo implanted with the neurostimulator Precision.	91
Reimplanted Patients 15 patients had a replacement with the neurostimulator Precision.	15
Total	106

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Lost to Follow-up	1

Baseline characteristics

Characteristic	Implanted Patients	Total	Reimplanted Patients
Age, Continuous	49.5 years STANDARD_DEVIATION 11	49.8 years STANDARD_DEVIATION 10.8	51.7 years STANDARD_DEVIATION 9.6
Duration of pain before implant	68.0 Months STANDARD_DEVIATION 68.5	75.4 Months STANDARD_DEVIATION 75.8	118.8 Months STANDARD_DEVIATION 101.6
Electrode insertion pathways Laminectomy	16 Participants	24 Participants	8 Participants
Electrode insertion pathways Percutaneous	73 Participants	79 Participants	6 Participants
Electrode insertion pathways Percutaneous + laminectomy	1 Participants	2 Participants	1 Participants
History of pain surgery	71 Participants	84 Participants	13 Participants
Indication Irreducible chronic neuropathic pain	85 Participants	100 Participants	15 Participants
Indication Peripheral ischaemic pain	2 Participants	2 Participants	0 Participants
% of patients with a test phase before final implantation	86 Participants	95 Participants	9 Participants
Pain location Bilateral pain	34 Participants	44 Participants	10 Participants
Pain location Unilateral pain	56 Participants	61 Participants	5 Participants
Percentage reduction in pain during the test phase	69.2 percentage STANDARD_DEVIATION 13.8	68.8 percentage STANDARD_DEVIATION 13.6	63.8 percentage STANDARD_DEVIATION 11.9
Race and Ethnicity Not Collected	—	0 Participants	—
Region of Enrollment France	91 participants	106 participants	15 participants
Sex: Female, Male Female	41 Participants	46 Participants	5 Participants
Sex: Female, Male Male	50 Participants	60 Participants	10 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	2 / 106	0 / 106
other Total, other adverse events	5 / 106	1 / 106
serious Total, serious adverse events	36 / 106	10 / 106

Outcome results

Primary

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.

Population: Implanted patients (de novo implants)

Arm	Measure	Group	Value (MEAN)
Implanted Patients (de Novo Implants)	Average Pain Score Over the Last 8 Days, Evaluated by Numerical Scale at 1 Year, and at 2 Years.	Average pain score for the past 8 days at 2 years	4.9 units on a scale
Implanted Patients (de Novo Implants)	Average Pain Score Over the Last 8 Days, Evaluated by Numerical Scale at 1 Year, and at 2 Years.	Average pain score for the past 8 days at 1 year	4.5 units on a scale

Primary

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.

Population: Implanted patients (de novo implants)

Arm	Measure	Group	Value (NUMBER)
Implanted Patients (de Novo Implants)	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.	% patients with pain reduction >= 50% at &1 year	34.5 percentage of patients
Implanted Patients (de Novo Implants)	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.	% patients with pain reduction >= 50% at 2 years	35.7 percentage of patients

Secondary

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.