Trial Outcomes & Findings for A Post Market Study to Assess the Spinal Modulation Neurostimulator System for Chronic Intractable Pain (NCT NCT02335502)

Last Updated: 2019-02-04

Results Overview

The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 10 cm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. The values range from 0 (minimum pain) to 10 (maximum pain).

Recruitment status

COMPLETED

Target enrollment

66 participants

Primary outcome timeframe

3, 6 and 12-Months

Results posted on

2019-02-04

Participant Flow

Participant milestones

Participant milestones
Measure	All Enrolled Subjects All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
Overall Study STARTED	66
Overall Study Received Trial System	65
Overall Study Receiving Permanent System	56
Overall Study COMPLETED	49
Overall Study NOT COMPLETED	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Post Market Study to Assess the Spinal Modulation Neurostimulator System for Chronic Intractable Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Enrolled Subjects n=66 Participants All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
Age, Continuous	52 years n=93 Participants
Sex: Female, Male Female	42 Participants n=93 Participants
Sex: Female, Male Male	24 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants
Race (NIH/OMB) White	65 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment Netherlands	66 participants n=93 Participants

PRIMARY outcome

Timeframe: 3, 6 and 12-Months

Population: Differences in participants over time is due to early withdrawals and missing data

Outcome measures

Outcome measures
Measure	Subjected Treated With the Permanent Implantable Axium System n=56 Participants All subjects treated with the Axium implantable neurostimulator
Change in Pain Intensity for Overall Pain From Pre-treatment Baseline Baseline	7.4 units on a scale Standard Deviation 1.41
Change in Pain Intensity for Overall Pain From Pre-treatment Baseline 3-Months	3.9 units on a scale Standard Deviation 2.63
Change in Pain Intensity for Overall Pain From Pre-treatment Baseline 6-Months	4.5 units on a scale Standard Deviation 2.84
Change in Pain Intensity for Overall Pain From Pre-treatment Baseline 12-Months	4.7 units on a scale Standard Deviation 2.87

PRIMARY outcome

Timeframe: Baseline and End of Trial Visit

Population: All subjects treated with the Axium implantable neurostimulator who completed their end of trial visit.

Percent of subjects with at least a 50% reduction from the baseline pain VAS to the end of trial period VAS. The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 100 mm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level.

Outcome measures

Outcome measures
Measure	Subjected Treated With the Permanent Implantable Axium System n=47 Participants All subjects treated with the Axium implantable neurostimulator
Percentage of Subjects With at Least 50% Pain Reduction >= 50% Pain Reduction	29 Participants
Percentage of Subjects With at Least 50% Pain Reduction < 50% Pain Reduction	18 Participants

Adverse Events

All Enrolled Subjects

Serious events: 8 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Enrolled Subjects n=66 participants at risk All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
Injury, poisoning and procedural complications Dural puncture	1.5% 1/66 • Number of events 1 • All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded from the time of enrollment to study completion or early withdrawal.
Injury, poisoning and procedural complications Hematoma/Infection	1.5% 1/66 • Number of events 1 • All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded from the time of enrollment to study completion or early withdrawal.
Infections and infestations Infection	6.1% 4/66 • Number of events 4 • All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded from the time of enrollment to study completion or early withdrawal.
Injury, poisoning and procedural complications Motor deficit-transient	1.5% 1/66 • Number of events 1 • All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded from the time of enrollment to study completion or early withdrawal.
Nervous system disorders Return of symptoms/worsening of disease state	1.5% 1/66 • Number of events 1 • All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded from the time of enrollment to study completion or early withdrawal.

Other adverse events

Other adverse events
Measure	All Enrolled Subjects n=66 participants at risk All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
Injury, poisoning and procedural complications Hematoma (became SAE)	1.5% 1/66 • Number of events 1 • All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded from the time of enrollment to study completion or early withdrawal.
Infections and infestations Infection	1.5% 1/66 • Number of events 1 • All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded from the time of enrollment to study completion or early withdrawal.
Infections and infestations Infection (became SAE)	1.5% 1/66 • Number of events 1 • All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded from the time of enrollment to study completion or early withdrawal.
Injury, poisoning and procedural complications Loss of stimulation	3.0% 2/66 • Number of events 2 • All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded from the time of enrollment to study completion or early withdrawal.
Injury, poisoning and procedural complications Pain at IPG site	3.0% 2/66 • Number of events 2 • All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded from the time of enrollment to study completion or early withdrawal.
Injury, poisoning and procedural complications Spinal tap headache	1.5% 1/66 • Number of events 1 • All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded from the time of enrollment to study completion or early withdrawal.

Additional Information

Roni Diaz

St. Jude Medical

Phone: +19723098601

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60