Failed Back Surgery Syndrome
Conditions
Brief summary
18-SMI-2013 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of chronic pain following lumbar discectomy (Failed Back Surgery Syndrome)
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 pain following surgical lumbar discectomy 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 subjects primary area of pain 6. Subject is able to provide written informed consent
Exclusion criteria
1. Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the study 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. 12. Subject has an anatomical spinal abnormality which is anticipated to require further surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain Intensity for Overall Pain From Pre-treatment Baseline | 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 | 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
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 | 22 |
| Total | 22 |
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 | 1 Participants |
| Race (NIH/OMB) White | 21 Participants |
| Region of Enrollment Netherlands | 22 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 7 / 22 |
| serious Total, serious adverse events | 1 / 22 |
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 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 | 7.7 units on a scale | Standard Deviation 1.1 |
| Subjected Treated With the Permanent Implantable Axium System | Change in Pain Intensity for Overall Pain From Pre-treatment Baseline | 3-Month Visit | 2.9 units on a scale | Standard Deviation 3 |
| Subjected Treated With the Permanent Implantable Axium System | Change in Pain Intensity for Overall Pain From Pre-treatment Baseline | 6-Month Visit | 2.6 units on a scale | Standard Deviation 3.6 |
| Subjected Treated With the Permanent Implantable Axium System | Change in Pain Intensity for Overall Pain From Pre-treatment Baseline | 12-Month Visit | 2.4 units on a scale | Standard Deviation 2.9 |
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 | 9 Participants |
| Subjected Treated With the Permanent Implantable Axium System | Percentage of Subjects With at Least 50% Pain Reduction | 6-Month Visit | 8 Participants |
| Subjected Treated With the Permanent Implantable Axium System | Percentage of Subjects With at Least 50% Pain Reduction | 12-Month Visit | 7 Participants |