Trial Outcomes & Findings for A Post Market Cohort to Assess the Performance of the Spinal Modulation Neurostimulator System for the Management of Chronic Neuropathic Pain of the Foot and/or Lower Leg (NCT NCT02335489)

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) to 10 (maximum).

Recruitment status

TERMINATED

Target enrollment

10 participants

Primary outcome timeframe

Baseline, 3, 6 and12-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 for the Management of Chronic Neuropathic Pain of the Foot and/or Lower Leg
Overall Study STARTED	10
Overall Study Received Trial System	9
Overall Study Receiving Permanent System	8
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	All Enrolled Subjects All subjects enrolled into the study with intent to treat with the Axium Neurostimulator for the Management of Chronic Neuropathic Pain of the Foot and/or Lower Leg
Overall Study Sponsor terminated study	4
Overall Study Lost to Follow-up	1
Overall Study Withdrawal by Subject	2
Overall Study Physician Decision	2
Overall Study Lack of Efficacy	1

Baseline Characteristics

A Post Market Cohort to Assess the Performance of the Spinal Modulation Neurostimulator System for the Management of Chronic Neuropathic Pain of the Foot and/or Lower Leg

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Enrolled Subjects n=10 Participants All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
Age, Continuous	54 years n=99 Participants
Sex: Female, Male Female	7 Participants n=99 Participants
Sex: Female, Male Male	3 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	9 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants
Region of Enrollment Belgium	10 Participants n=99 Participants

PRIMARY outcome

Timeframe: Baseline, 3, 6 and12-Months

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

Outcome measures

Outcome measures
Measure	All Enrolled Subjects n=8 Participants All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
Change in Pain Intensity for Overall Pain From Pre-treatment Baseline Baseline	8.0 units on a scale Standard Deviation 1.5
Change in Pain Intensity for Overall Pain From Pre-treatment Baseline 3-Months	4.7 units on a scale Standard Deviation 3.2
Change in Pain Intensity for Overall Pain From Pre-treatment Baseline 6-Months	6.4 units on a scale Standard Deviation 2.3
Change in Pain Intensity for Overall Pain From Pre-treatment Baseline 12-Months	5.4 units on a scale Standard Deviation 0.3

Adverse Events

All Enrolled Subjects

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Enrolled Subjects n=10 participants at risk All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
Musculoskeletal and connective tissue disorders Central disc hernia at L5-S1 and discreet bulging at L4-L5	10.0% 1/10 • 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=10 participants at risk All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
Injury, poisoning and procedural complications Headache and nausea	10.0% 1/10 • 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: +1 972 309 8601

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60