Chronic Pain
Conditions
Brief summary
11-SMI-2013 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of intractable, chronic 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 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 VAS 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 or plans to become pregnant during the study duration 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 DRG within the past 3 months 5. Subject currently has an active implantable device including ICD, 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 participated in another clinical investigation within 30 days 9. Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation 10. Subject has been diagnosed with cancer in the past 2 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity in Primary Region of Pain | Post treatment at 3, 6 and 12 months | Assessed by Change in Pain Intensity on a Visual Analogue Scale (VAS) 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). |
| Pain Intensity in Overall Pain | Post treatment at 3, 6 and 12 months | Assessed by Change in Pain Intensity on a Visual Analogue Scale (VAS) 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). |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Enrolled Subjects All subjects enrolled into the study with intent to treat with the Axium Neurostimulator | 41 |
| Total | 41 |
Baseline characteristics
| Characteristic | All Enrolled Subjects |
|---|---|
| Age, Continuous | 47 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 | 41 Participants |
| Region of Enrollment Sweden | 41 participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 41 |
| serious Total, serious adverse events | 1 / 41 |
Outcome results
Primary
Pain Intensity in Overall Pain
Assessed by Change in Pain Intensity on a Visual Analogue Scale (VAS) 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: Post treatment at 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 | Pain Intensity in Overall Pain | Baseline | 7.5 units on a scale | Standard Deviation 1.5 |
| Subjected Treated With the Permanent | Pain Intensity in Overall Pain | 3-Month Visit | 5.3 units on a scale | Standard Deviation 2.3 |
| Subjected Treated With the Permanent | Pain Intensity in Overall Pain | 6-Month Visit | 5.4 units on a scale | Standard Deviation 2.8 |
| Subjected Treated With the Permanent | Pain Intensity in Overall Pain | 12-Month Visit | 5.6 units on a scale | Standard Deviation 2.3 |
Primary
Pain Intensity in Primary Region of Pain
Assessed by Change in Pain Intensity on a Visual Analogue Scale (VAS) 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: Post treatment at 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 | Pain Intensity in Primary Region of Pain | 12-Month Visit | 4.8 units on a scale | Standard Deviation 2.8 |
| Subjected Treated With the Permanent | Pain Intensity in Primary Region of Pain | Baseline | 7.6 units on a scale | Standard Deviation 1.3 |
| Subjected Treated With the Permanent | Pain Intensity in Primary Region of Pain | 3-Month Visit | 4.9 units on a scale | Standard Deviation 2.4 |
| Subjected Treated With the Permanent | Pain Intensity in Primary Region of Pain | 6-Month Visit | 5.3 units on a scale | Standard Deviation 2.7 |