Chronic Neuropathic Pain
Conditions
Brief summary
14-SMI-2013 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of neuropathic pain of the foot and/or lower limb
Interventions
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is at least 18 years old 2. Subject is able and willing to comply with the follow-up schedule and protocol 3. Chronic, intractable pain in the foot and/or lower leg for at least 6 months 4. Failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and interventional pain procedures for chronic pain 5. Minimum baseline pain rating of 60 mm on the Visual Analog Scale in the primary region of pain 6. Subject is able to provide written informed consent
Exclusion criteria
1. Female subject of childbearing potential is pregnant/nursing, plans to become pregnant or is unwilling to use approved birth control 2. Escalating or changing pain condition within the past month as evidenced by investigator examination 3. Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days 4. Subject has had radiofrequency treatment of an intended target Dorsal Root Ganglion within the past 3 months 5. Subject currently has an active implantable device including implantable cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump 6. Subject is unable to operate the device 7. Subjects with indwelling devices that may pose an increased risk of infection 8. Subjects currently has an active infection 9. Subject has participated in another clinical investigation within 30 days 10. Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation 11. Subject has been diagnosed with cancer in the past 2 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity for Overall Pain From Pre-treatment Baseline | Baseline, 3, 6 and12-Months | 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). |
Countries
Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Enrolled Subjects All subjects enrolled into the study with intent to treat with the Axium Neurostimulator | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Sponsor terminated study | 4 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | All Enrolled Subjects |
|---|---|
| Age, Continuous | 54 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Region of Enrollment Belgium | 10 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 10 |
| serious Total, serious adverse events | 1 / 10 |
Outcome results
Primary
Change in Pain Intensity for Overall Pain 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) to 10 (maximum).
Time frame: Baseline, 3, 6 and12-Months
Population: Differences in participants over time is due to early withdrawals and missing data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Enrolled Subjects | Change in Pain Intensity for Overall Pain From Pre-treatment Baseline | Baseline | 8.0 units on a scale | Standard Deviation 1.5 |
| All Enrolled Subjects | Change in Pain Intensity for Overall Pain From Pre-treatment Baseline | 12-Months | 5.4 units on a scale | Standard Deviation 0.3 |
| All Enrolled Subjects | Change in Pain Intensity for Overall Pain From Pre-treatment Baseline | 3-Months | 4.7 units on a scale | Standard Deviation 3.2 |
| All Enrolled Subjects | Change in Pain Intensity for Overall Pain From Pre-treatment Baseline | 6-Months | 6.4 units on a scale | Standard Deviation 2.3 |