Chronic Pain
Conditions
Brief summary
04-SMI-2012 is post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of chronic, intractable pain.
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 thoracic, lumbar and/or sacral distribution(s) 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. 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 8. Subject speaks Dutch or English
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. Patient has pain only or primarily within a cervical dermatomal distribution 7. Subject is unable to operate the device 8. Subjects with indwelling devices that may pose an increased risk of infection 9. Subjects currently has an active infection 10. Subject has, in the opinion of the Investigator, a medical comorbidity that contraindicates placement of an active medical device 11. Subject has participated in another clinical investigation within 30 days 12. Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation 13. 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 | 3, 6 and 12-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 pain) to 10 (maximum pain). |
| Percentage of Subjects With at Least 50% Pain Reduction | Baseline and End of Trial Visit | Percent of subjects with at least a 50% reduction from the baseline pain VAS to the end of trial period VAS. The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 100 mm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level. |
Countries
Netherlands
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Enrolled Subjects All subjects enrolled into the study with intent to treat with the Axium Neurostimulator | 66 |
| Total | 66 |
Baseline characteristics
| Characteristic | All Enrolled Subjects |
|---|---|
| Age, Continuous | 52 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 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 | 65 Participants |
| Region of Enrollment Netherlands | 66 participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 66 |
| serious Total, serious adverse events | 8 / 66 |
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: 3, 6 and 12-Months
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 1.41 |
| Subjected Treated With the Permanent Implantable Axium System | Change in Pain Intensity for Overall Pain From Pre-treatment Baseline | 3-Months | 3.9 units on a scale | Standard Deviation 2.63 |
| Subjected Treated With the Permanent Implantable Axium System | Change in Pain Intensity for Overall Pain From Pre-treatment Baseline | 6-Months | 4.5 units on a scale | Standard Deviation 2.84 |
| Subjected Treated With the Permanent Implantable Axium System | Change in Pain Intensity for Overall Pain From Pre-treatment Baseline | 12-Months | 4.7 units on a scale | Standard Deviation 2.87 |
Primary
Percentage of Subjects With at Least 50% Pain Reduction
Percent of subjects with at least a 50% reduction from the baseline pain VAS to the end of trial period VAS. The Visual Analog Scale (VAS) is self-administered instrument assessing average pain intensity. Subjects rated their pain on a horizontal line, 100 mm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher pain level.
Time frame: Baseline and End of Trial Visit
Population: All subjects treated with the Axium implantable neurostimulator who completed their end of trial visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Subjected Treated With the Permanent Implantable Axium System | Percentage of Subjects With at Least 50% Pain Reduction | >= 50% Pain Reduction | 29 Participants |
| Subjected Treated With the Permanent Implantable Axium System | Percentage of Subjects With at Least 50% Pain Reduction | < 50% Pain Reduction | 18 Participants |