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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated subjects | All subjects recruited and treated with the Axium Neurostimulator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation with the commercially available Axium Neurostimulator | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Post implantation at; 1, 3, 6, 12 and 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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Chronic Pain Patients
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| Name | Affiliation | Role |
|---|---|---|
| S ElDabe, Prof | James Cook University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James Cook University Hospital | Middlesbrough | TS4 3BW | United Kingdom |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treated Subjects | All subjects recruited and treated with the Axium Neurostimulator. Implantation with the commercially available Axium Neurostimulator. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treated Subjects | All subjects recruited and treated with the Axium Neurostimulator. Implantation with the commercially available Axium Neurostimulator. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Subject attrition reduced the number of participating and analyzable subjects at all subsequent visits post-implant. | Posted | Mean | Standard Deviation | cm | Post implantation at; 1, 3, 6, 12 and 24 months |
Adverse Event data collected from the time subject is enrolled (upon informed consent) through 6 months follow-up or withdrawal, whichever occurred first.
Adverse Event - untoward medical occurrence, unintended disease/injury, untoward clinical sign whether or not related to the investigational device. Serious criteria: AE that led to death, serious deterioration subject health or fetal distress, death or congenital abnormality/birth defect.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treated Subjects | All subjects treated with the Axium Neurostimulator. | 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain/discomfort in target area | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain/discomfort at IPG site | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robyn Capobianco | Abbott | 512-286-4274 | robyn.capobianco@abbott.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 13, 2014 | Aug 23, 2024 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | 3 subjects did not disclose their race | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Weight was not available for 7 subjects. | Mean | Full Range | kg |
|
| Height | Height not available for 2 subjects. | Mean | Full Range | cm |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Treated Subjects | All subjects who receive the Axium neurostimulator |
|
|
| 135 |
| 4 |
| 135 |
| 35 |
| 135 |
| Abcess at lead site | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Leg pain and numbness | General disorders | Systematic Assessment |
|
| Loss of stimulation | Product Issues | Systematic Assessment |
|
| Lead migration | Product Issues | Systematic Assessment |
|
| IPG migration | Product Issues | Systematic Assessment |
|
| Increasing pain in target area | General disorders | Systematic Assessment |
|
| Painful/unpleasant stimulation | General disorders | Systematic Assessment |
|
| Pain/discomfort at IPG site and pain in leg | General disorders | Systematic Assessment |
|
| Cerebral spinal fluid leakage | Surgical and medical procedures | Systematic Assessment |
|
| Lead impedance out of range | Product Issues | Systematic Assessment |
|
| Skin erosion | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Foreign object in epidural space | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Loss of stimulation | Product Issues | Systematic Assessment |
|
| Pocket infection | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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