Trial Outcomes & Findings for A Multi-centre Observational Study of the Axium Neurostimulator as a Treatment for Chronic Pain (NCT NCT02169401)

Last Updated: 2024-11-14

Results Overview

The visual analog is a widely accepted measure of pain intensity. VAS scale ranges from 0 to 10, where 0 is the minimum and 10 is the maximum score. A higher score indicates greater pain intensity (listed below are some citations to illustrate this point). An increase in VAS scores conveys an increase in pain. Jensen, Mark P., Connie Chen, and Andrew M. Brugger. "Interpretation of visual analog scale ratings and change scores: a reanalysis of two clinical trials of postoperative pain." The Journal of pain 4.7 (2003): 407-414. MPQ, M. (2011). Measures of adult pain. Arthritis Care Res., 63, S240-S252. Hawker, G. A., Mian, S., Kendzerska, T., \& French, M. (2011). Measures of adult pain: Visual analog scale for pain (vas pain), numeric rating scale for pain (nrs pain), mcgill pain questionnaire (mpq), short-form mcgill pain questionnaire (sf-mpq), chronic pain grade scale (cpgs), short form-36 bodily pain scale (sf-36 bps), and measure of intermittent and constant osteoarthritis pain.

Recruitment status

COMPLETED

Target enrollment

135 participants

Primary outcome timeframe

Post implantation at; 1, 3, 6, 12 and 24 months

Results posted on

2024-11-14

Participant Flow

Participant milestones

Participant milestones
Measure	Treated Subjects All subjects recruited and treated with the Axium Neurostimulator. Implantation with the commercially available Axium Neurostimulator.
Overall Study STARTED	135
Overall Study COMPLETED	108
Overall Study NOT COMPLETED	27

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

3 subjects did not disclose their race

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treated Subjects n=135 Participants All subjects recruited and treated with the Axium Neurostimulator. Implantation with the commercially available Axium Neurostimulator.
Age, Categorical <=18 years	0 Participants n=135 Participants
Age, Categorical Between 18 and 65 years	122 Participants n=135 Participants
Age, Categorical >=65 years	13 Participants n=135 Participants
Age, Continuous	49 years n=135 Participants
Sex: Female, Male Female	58 Participants n=135 Participants
Sex: Female, Male Male	77 Participants n=135 Participants
Race/Ethnicity, Customized Race · Caucasian/White	130 Participants n=132 Participants • 3 subjects did not disclose their race
Race/Ethnicity, Customized Race · Asian	1 Participants n=132 Participants • 3 subjects did not disclose their race
Race/Ethnicity, Customized Race · Afro-Caribbean	1 Participants n=132 Participants • 3 subjects did not disclose their race
Region of Enrollment United Kingdom	135 participants n=135 Participants
Weight	81 kg n=128 Participants • Weight was not available for 7 subjects.
Height	160 cm n=133 Participants • Height not available for 2 subjects.

PRIMARY outcome

Timeframe: Post implantation at; 1, 3, 6, 12 and 24 months

Population: Subject attrition reduced the number of participating and analyzable subjects at all subsequent visits post-implant.

Outcome measures

Outcome measures
Measure	Treated Subjects n=135 Participants All subjects who receive the Axium neurostimulator
Pain Relief- Change in VAS Pain Intensity From Baseline to Post Implantation Baseline	7.5 cm Standard Deviation 1.7
Pain Relief- Change in VAS Pain Intensity From Baseline to Post Implantation 1-Month Visit	4.4 cm Standard Deviation 2.8
Pain Relief- Change in VAS Pain Intensity From Baseline to Post Implantation 3-Month Visit	5.2 cm Standard Deviation 2.5
Pain Relief- Change in VAS Pain Intensity From Baseline to Post Implantation 6-Month Visit	4.7 cm Standard Deviation 2.6
Pain Relief- Change in VAS Pain Intensity From Baseline to Post Implantation 12-Month Visit	4.9 cm Standard Deviation 2.8
Pain Relief- Change in VAS Pain Intensity From Baseline to Post Implantation 24-Month Visit	4.4 cm Standard Deviation 2.8

Adverse Events

Treated Subjects

Serious events: 4 serious events

Other events: 35 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Treated Subjects n=135 participants at risk All subjects treated with the Axium Neurostimulator.
General disorders Pain/discomfort in target area	0.74% 1/135 • Number of events 1 • Adverse Event data collected from the time subject is enrolled (upon informed consent) through 6 months follow-up or withdrawal, whichever occurred first. Adverse Event - untoward medical occurrence, unintended disease/injury, untoward clinical sign whether or not related to the investigational device. Serious criteria: AE that led to death, serious deterioration subject health or fetal distress, death or congenital abnormality/birth defect.
Skin and subcutaneous tissue disorders Abcess at lead site	0.74% 1/135 • Number of events 1 • Adverse Event data collected from the time subject is enrolled (upon informed consent) through 6 months follow-up or withdrawal, whichever occurred first. Adverse Event - untoward medical occurrence, unintended disease/injury, untoward clinical sign whether or not related to the investigational device. Serious criteria: AE that led to death, serious deterioration subject health or fetal distress, death or congenital abnormality/birth defect.
General disorders Leg pain and numbness	0.74% 1/135 • Number of events 1 • Adverse Event data collected from the time subject is enrolled (upon informed consent) through 6 months follow-up or withdrawal, whichever occurred first. Adverse Event - untoward medical occurrence, unintended disease/injury, untoward clinical sign whether or not related to the investigational device. Serious criteria: AE that led to death, serious deterioration subject health or fetal distress, death or congenital abnormality/birth defect.
Product Issues Loss of stimulation	0.74% 1/135 • Number of events 1 • Adverse Event data collected from the time subject is enrolled (upon informed consent) through 6 months follow-up or withdrawal, whichever occurred first. Adverse Event - untoward medical occurrence, unintended disease/injury, untoward clinical sign whether or not related to the investigational device. Serious criteria: AE that led to death, serious deterioration subject health or fetal distress, death or congenital abnormality/birth defect.

Other adverse events

Other adverse events
Measure	Treated Subjects n=135 participants at risk All subjects treated with the Axium Neurostimulator.
General disorders Pain/discomfort at IPG site	11.1% 15/135 • Number of events 15 • Adverse Event data collected from the time subject is enrolled (upon informed consent) through 6 months follow-up or withdrawal, whichever occurred first. Adverse Event - untoward medical occurrence, unintended disease/injury, untoward clinical sign whether or not related to the investigational device. Serious criteria: AE that led to death, serious deterioration subject health or fetal distress, death or congenital abnormality/birth defect.
Product Issues Lead migration	5.2% 7/135 • Number of events 7 • Adverse Event data collected from the time subject is enrolled (upon informed consent) through 6 months follow-up or withdrawal, whichever occurred first. Adverse Event - untoward medical occurrence, unintended disease/injury, untoward clinical sign whether or not related to the investigational device. Serious criteria: AE that led to death, serious deterioration subject health or fetal distress, death or congenital abnormality/birth defect.
Product Issues IPG migration	1.5% 2/135 • Number of events 2 • Adverse Event data collected from the time subject is enrolled (upon informed consent) through 6 months follow-up or withdrawal, whichever occurred first. Adverse Event - untoward medical occurrence, unintended disease/injury, untoward clinical sign whether or not related to the investigational device. Serious criteria: AE that led to death, serious deterioration subject health or fetal distress, death or congenital abnormality/birth defect.
General disorders Increasing pain in target area	0.74% 1/135 • Number of events 1 • Adverse Event data collected from the time subject is enrolled (upon informed consent) through 6 months follow-up or withdrawal, whichever occurred first. Adverse Event - untoward medical occurrence, unintended disease/injury, untoward clinical sign whether or not related to the investigational device. Serious criteria: AE that led to death, serious deterioration subject health or fetal distress, death or congenital abnormality/birth defect.
General disorders Painful/unpleasant stimulation	1.5% 2/135 • Number of events 2 • Adverse Event data collected from the time subject is enrolled (upon informed consent) through 6 months follow-up or withdrawal, whichever occurred first. Adverse Event - untoward medical occurrence, unintended disease/injury, untoward clinical sign whether or not related to the investigational device. Serious criteria: AE that led to death, serious deterioration subject health or fetal distress, death or congenital abnormality/birth defect.
General disorders Pain/discomfort at IPG site and pain in leg	0.74% 1/135 • Number of events 1 • Adverse Event data collected from the time subject is enrolled (upon informed consent) through 6 months follow-up or withdrawal, whichever occurred first. Adverse Event - untoward medical occurrence, unintended disease/injury, untoward clinical sign whether or not related to the investigational device. Serious criteria: AE that led to death, serious deterioration subject health or fetal distress, death or congenital abnormality/birth defect.
Surgical and medical procedures Cerebral spinal fluid leakage	0.74% 1/135 • Number of events 1 • Adverse Event data collected from the time subject is enrolled (upon informed consent) through 6 months follow-up or withdrawal, whichever occurred first. Adverse Event - untoward medical occurrence, unintended disease/injury, untoward clinical sign whether or not related to the investigational device. Serious criteria: AE that led to death, serious deterioration subject health or fetal distress, death or congenital abnormality/birth defect.
Product Issues Lead impedance out of range	0.74% 1/135 • Number of events 1 • Adverse Event data collected from the time subject is enrolled (upon informed consent) through 6 months follow-up or withdrawal, whichever occurred first. Adverse Event - untoward medical occurrence, unintended disease/injury, untoward clinical sign whether or not related to the investigational device. Serious criteria: AE that led to death, serious deterioration subject health or fetal distress, death or congenital abnormality/birth defect.
Skin and subcutaneous tissue disorders Skin erosion	0.74% 1/135 • Number of events 1 • Adverse Event data collected from the time subject is enrolled (upon informed consent) through 6 months follow-up or withdrawal, whichever occurred first. Adverse Event - untoward medical occurrence, unintended disease/injury, untoward clinical sign whether or not related to the investigational device. Serious criteria: AE that led to death, serious deterioration subject health or fetal distress, death or congenital abnormality/birth defect.
Musculoskeletal and connective tissue disorders Foreign object in epidural space	0.74% 1/135 • Number of events 1 • Adverse Event data collected from the time subject is enrolled (upon informed consent) through 6 months follow-up or withdrawal, whichever occurred first. Adverse Event - untoward medical occurrence, unintended disease/injury, untoward clinical sign whether or not related to the investigational device. Serious criteria: AE that led to death, serious deterioration subject health or fetal distress, death or congenital abnormality/birth defect.
Product Issues Loss of stimulation	2.2% 3/135 • Number of events 3 • Adverse Event data collected from the time subject is enrolled (upon informed consent) through 6 months follow-up or withdrawal, whichever occurred first. Adverse Event - untoward medical occurrence, unintended disease/injury, untoward clinical sign whether or not related to the investigational device. Serious criteria: AE that led to death, serious deterioration subject health or fetal distress, death or congenital abnormality/birth defect.
Skin and subcutaneous tissue disorders Pocket infection	0.74% 1/135 • Number of events 1 • Adverse Event data collected from the time subject is enrolled (upon informed consent) through 6 months follow-up or withdrawal, whichever occurred first. Adverse Event - untoward medical occurrence, unintended disease/injury, untoward clinical sign whether or not related to the investigational device. Serious criteria: AE that led to death, serious deterioration subject health or fetal distress, death or congenital abnormality/birth defect.

Additional Information

Robyn Capobianco

Abbott

Phone: 512-286-4274

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60