Trial Outcomes & Findings for A Post Market Evaluation of Chronic intractaBle paIN and the Efficacy of drG stimulatiOn in the Nordic Region (NCT NCT02346643)

Last Updated: 2019-02-04

Results Overview

Assessed by Change in Pain Intensity on a Visual Analogue Scale (VAS) from Pre-Treatment Baseline. 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

TERMINATED

Target enrollment

41 participants

Primary outcome timeframe

Post treatment at 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	41
Overall Study Received Trial System	29
Overall Study Received Permanent System	31
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	35

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Post Market Evaluation of Chronic intractaBle paIN and the Efficacy of drG stimulatiOn in the Nordic Region

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Enrolled Subjects n=41 Participants All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
Age, Continuous	47 years n=99 Participants
Sex: Female, Male Female	27 Participants n=99 Participants
Sex: Female, Male Male	14 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	41 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment Sweden	41 participants n=99 Participants

PRIMARY outcome

Timeframe: Post treatment at 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 n=31 Participants All subjects treated with the Axium implantable neurostimulator
Pain Intensity in Primary Region of Pain Baseline	7.6 units on a scale Standard Deviation 1.3
Pain Intensity in Primary Region of Pain 3-Month Visit	4.9 units on a scale Standard Deviation 2.4
Pain Intensity in Primary Region of Pain 6-Month Visit	5.3 units on a scale Standard Deviation 2.7
Pain Intensity in Primary Region of Pain 12-Month Visit	4.8 units on a scale Standard Deviation 2.8

PRIMARY outcome

Timeframe: Post treatment at 3, 6 and 12 months

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

Assessed by Change in Pain Intensity on a Visual Analogue Scale (VAS) from Pre-Treatment Baseline 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).

Outcome measures

Outcome measures
Measure	Subjected Treated With the Permanent n=31 Participants All subjects treated with the Axium implantable neurostimulator
Pain Intensity in Overall Pain 6-Month Visit	5.4 units on a scale Standard Deviation 2.8
Pain Intensity in Overall Pain 12-Month Visit	5.6 units on a scale Standard Deviation 2.3
Pain Intensity in Overall Pain 3-Month Visit	5.3 units on a scale Standard Deviation 2.3
Pain Intensity in Overall Pain Baseline	7.5 units on a scale Standard Deviation 1.5

Adverse Events

All Enrolled Subjects

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	All Enrolled Subjects n=41 participants at risk All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
Injury, poisoning and procedural complications Post-dural puncture headache	2.4% 1/41 • Number of events 1

Other adverse events

Other adverse events
Measure	All Enrolled Subjects n=41 participants at risk All subjects enrolled into the study with intent to treat with the Axium Neurostimulator
Injury, poisoning and procedural complications IPG Pocket Pain	2.4% 1/41 • Number of events 1
Investigations High Lead Impedance	2.4% 1/41 • Number of events 1
Injury, poisoning and procedural complications Loss of Stimulation	4.9% 2/41 • Number of events 2
Injury, poisoning and procedural complications Lead Severed	2.4% 1/41 • Number of events 1
Injury, poisoning and procedural complications Pain at Incision Site	4.9% 2/41 • Number of events 2
Cardiac disorders Arrhythmia and Irregularities	2.4% 1/41 • Number of events 1
General disorders Back Pain	2.4% 1/41 • Number of events 1
General disorders Erythema or Drainage or Inflammation	4.9% 2/41 • Number of events 2
General disorders Fever	2.4% 1/41 • Number of events 1
Injury, poisoning and procedural complications Gluteal muscle pain	2.4% 1/41 • Number of events 1
General disorders Upper Extremities Pain	2.4% 1/41 • Number of events 1

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