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Budget Allocation Decision by Sponsor
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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
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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 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). | Post treatment at 3, 6 and 12 months |
| 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). | Post treatment at 3, 6 and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Chronic Pain Patients
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska Universitetssjukhuset | Gothenburg | Sweden | ||||
| Akademiska sjukhuest |
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| ID | Title | Description |
|---|---|---|
| FG000 | All Enrolled Subjects | All subjects enrolled into the study with intent to treat with the Axium Neurostimulator |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Enrolled Subjects | All subjects enrolled into the study with intent to treat with the Axium Neurostimulator |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 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). | Differences in participants over time is due to early withdrawals and missing data | Posted | Mean | Standard Deviation | units on a scale | Post treatment at 3, 6 and 12 months |
|
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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 | All Enrolled Subjects | All subjects enrolled into the study with intent to treat with the Axium Neurostimulator |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post-dural puncture headache | Injury, poisoning and procedural complications | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| IPG Pocket Pain | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roni Diaz | St. Jude Medical | +1 972 309 8601 | RDiaz@sjm.com |
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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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| Uppsala |
| Sweden |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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). | Differences in participants over time is due to early withdrawals and missing data | Posted | Mean | Standard Deviation | units on a scale | Post treatment at 3, 6 and 12 months |
|
|
|
| 1 |
| 41 |
| 7 |
| 41 |
| High Lead Impedance | Investigations | Non-systematic Assessment |
|
| Loss of Stimulation | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Lead Severed | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Pain at Incision Site | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Arrhythmia and Irregularities | Cardiac disorders | Non-systematic Assessment |
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| Back Pain | General disorders | Non-systematic Assessment |
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| Erythema or Drainage or Inflammation | General disorders | Non-systematic Assessment |
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| Fever | General disorders | Non-systematic Assessment |
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| Gluteal muscle pain | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Upper Extremities Pain | General disorders | Non-systematic Assessment |
|
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| 6-Month Visit |
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| 12-Month Visit |
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