Peripheral Neuropathy
Conditions
Brief summary
10-SMI-2012 is a post market observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of peripheral neuropathy
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. Peripheral neuropathy 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. Average baseline pain rating of 60 mm on the Visual Analog Scale in the primary region of pain 6. In the opinion of the Investigator, the subject is psychologically appropriate for the implantation for an active implantable medical device 7. 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 implanted cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump 6. Subject is unable to operate the device 7. Subjects currently has an active infection 8. Subject has, in the opinion of the Investigator, a medical comorbidity that contraindicates placement of an active medical device 9. Subject has participated in another clinical investigation within 30 days that may confound the outcomes of the current study as determined by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity for Overall Pain From Pre-treatment Baseline | Baseline, 3, 6 and 12-Month Visits | 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). |
| Percentage of Subjects With at Least 50% Pain Reduction | 3, 6 and 12-Month Visits | Percent of subjects with at least a 50% reduction. 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
Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Enrolled Subjects All subjects enrolled into the study with intent to treat with the Axium Neurostimulator | 33 |
| Total | 33 |
Baseline characteristics
| Characteristic | All Enrolled Subjects |
|---|---|
| Age, Continuous | 51 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 | 0 Participants |
| Race (NIH/OMB) White | 33 Participants |
| Region of Enrollment Germany | 33 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 33 |
| other Total, other adverse events | 5 / 33 |
| serious Total, serious adverse events | 8 / 33 |
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 pain) to 10 (maximum pain).
Time frame: Baseline, 3, 6 and 12-Month Visits
Population: Differences in participants over time is due to early withdrawals and missing data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subjected Treated With the Permanent Implantable Axium System | Change in Pain Intensity for Overall Pain From Pre-treatment Baseline | Baseline | 7.4 units on a scale | Standard Deviation 1.7 |
| Subjected Treated With the Permanent Implantable Axium System | Change in Pain Intensity for Overall Pain From Pre-treatment Baseline | 3-Month Visit | 4.0 units on a scale | Standard Deviation 2.6 |
| Subjected Treated With the Permanent Implantable Axium System | Change in Pain Intensity for Overall Pain From Pre-treatment Baseline | 6-Month Visit | 3.4 units on a scale | Standard Deviation 2.5 |
| Subjected Treated With the Permanent Implantable Axium System | Change in Pain Intensity for Overall Pain From Pre-treatment Baseline | 12-Month Visit | 3.8 units on a scale | Standard Deviation 2.5 |
Primary
Percentage of Subjects With at Least 50% Pain Reduction
Percent of subjects with at least a 50% reduction. 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: 3, 6 and 12-Month Visits
Population: Differences in participants over time is due to early withdrawals and missing data
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subjected Treated With the Permanent Implantable Axium System | Percentage of Subjects With at Least 50% Pain Reduction | 3-Month Visit | 13 Participants |
| Subjected Treated With the Permanent Implantable Axium System | Percentage of Subjects With at Least 50% Pain Reduction | 6-Month Visit | 14 Participants |
| Subjected Treated With the Permanent Implantable Axium System | Percentage of Subjects With at Least 50% Pain Reduction | 12-Month Visit | 8 Participants |