Chronic Pain
Conditions
Brief summary
08-SMI-2012 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. 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 DRG 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 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 trial 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 |
|---|---|---|
| Pain Relief- Change in VAS Pain Intensity From Baseline to Post Implantation | Post implantation at; 1, 3, 6, 12 and 24 months | The visual analog is a widely accepted measure of pain intensity. VAS scale ranges from 0 to 10, where 0 is the minimum and 10 is the maximum score. A higher score indicates greater pain intensity (listed below are some citations to illustrate this point). An increase in VAS scores conveys an increase in pain. Jensen, Mark P., Connie Chen, and Andrew M. Brugger. Interpretation of visual analog scale ratings and change scores: a reanalysis of two clinical trials of postoperative pain. The Journal of pain 4.7 (2003): 407-414. MPQ, M. (2011). Measures of adult pain. Arthritis Care Res., 63, S240-S252. Hawker, G. A., Mian, S., Kendzerska, T., & French, M. (2011). Measures of adult pain: Visual analog scale for pain (vas pain), numeric rating scale for pain (nrs pain), mcgill pain questionnaire (mpq), short-form mcgill pain questionnaire (sf-mpq), chronic pain grade scale (cpgs), short form-36 bodily pain scale (sf-36 bps), and measure of intermittent and constant osteoarthritis pain. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treated Subjects All subjects recruited and treated with the Axium Neurostimulator.
Implantation with the commercially available Axium Neurostimulator. | 135 |
| Total | 135 |
Baseline characteristics
| Characteristic | Treated Subjects |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 13 Participants |
| Age, Categorical Between 18 and 65 years | 122 Participants |
| Age, Continuous | 49 years |
| Height | 160 cm |
| Race/Ethnicity, Customized Race Afro-Caribbean | 1 Participants |
| Race/Ethnicity, Customized Race Asian | 1 Participants |
| Race/Ethnicity, Customized Race Caucasian/White | 130 Participants |
| Region of Enrollment United Kingdom | 135 participants |
| Sex: Female, Male Female | 58 Participants |
| Sex: Female, Male Male | 77 Participants |
| Weight | 81 kg |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 135 |
| other Total, other adverse events | 35 / 135 |
| serious Total, serious adverse events | 4 / 135 |
Outcome results
Primary
Pain Relief- Change in VAS Pain Intensity From Baseline to Post Implantation
The visual analog is a widely accepted measure of pain intensity. VAS scale ranges from 0 to 10, where 0 is the minimum and 10 is the maximum score. A higher score indicates greater pain intensity (listed below are some citations to illustrate this point). An increase in VAS scores conveys an increase in pain. Jensen, Mark P., Connie Chen, and Andrew M. Brugger. Interpretation of visual analog scale ratings and change scores: a reanalysis of two clinical trials of postoperative pain. The Journal of pain 4.7 (2003): 407-414. MPQ, M. (2011). Measures of adult pain. Arthritis Care Res., 63, S240-S252. Hawker, G. A., Mian, S., Kendzerska, T., & French, M. (2011). Measures of adult pain: Visual analog scale for pain (vas pain), numeric rating scale for pain (nrs pain), mcgill pain questionnaire (mpq), short-form mcgill pain questionnaire (sf-mpq), chronic pain grade scale (cpgs), short form-36 bodily pain scale (sf-36 bps), and measure of intermittent and constant osteoarthritis pain.
Time frame: Post implantation at; 1, 3, 6, 12 and 24 months
Population: Subject attrition reduced the number of participating and analyzable subjects at all subsequent visits post-implant.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treated Subjects | Pain Relief- Change in VAS Pain Intensity From Baseline to Post Implantation | 6-Month Visit | 4.7 cm | Standard Deviation 2.6 |
| Treated Subjects | Pain Relief- Change in VAS Pain Intensity From Baseline to Post Implantation | Baseline | 7.5 cm | Standard Deviation 1.7 |
| Treated Subjects | Pain Relief- Change in VAS Pain Intensity From Baseline to Post Implantation | 1-Month Visit | 4.4 cm | Standard Deviation 2.8 |
| Treated Subjects | Pain Relief- Change in VAS Pain Intensity From Baseline to Post Implantation | 3-Month Visit | 5.2 cm | Standard Deviation 2.5 |
| Treated Subjects | Pain Relief- Change in VAS Pain Intensity From Baseline to Post Implantation | 12-Month Visit | 4.9 cm | Standard Deviation 2.8 |
| Treated Subjects | Pain Relief- Change in VAS Pain Intensity From Baseline to Post Implantation | 24-Month Visit | 4.4 cm | Standard Deviation 2.8 |