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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)
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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 |
|---|---|---|
| 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). | Baseline, 3, 6 and 12 Months |
| 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). | 3, 6 and 12-Month Visits |
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Inclusion Criteria:
Exclusion Criteria:
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Patients suffering from chronic pain post discectomy surgery
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Antonius Ziekenhuis | Nieuwegein | Netherlands |
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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 | 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). | Differences in participants over time is due to early withdrawals and missing data | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3, 6 and 12 Months |
|
All adverse events reported spontaneously by the subject or observed by the investigator or his staff were recorded from the time of enrollment to study completion or early withdrawal.
All-cause mortality was not assessed in this study.
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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 |
|---|---|---|---|---|---|
| Abdominal pain | Hepatobiliary disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| IPG Pocket Pain | Injury, poisoning and procedural complications |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roni Diaz | St. Jude Medical | +19723098601 | rdiaz@sjm.com |
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| ID | Term |
|---|---|
| D055111 | Failed Back Surgery Syndrome |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001416 | Back Pain |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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). | Differences in participants over time is due to early withdrawals and missing data | Posted | Count of Participants | Participants | 3, 6 and 12-Month Visits |
|
|
|
| 0 |
| 0 |
| 1 |
| 22 |
| 7 |
| 22 |
| Buzzing noise in left ear | Ear and labyrinth disorders |
|
| Fall | Injury, poisoning and procedural complications |
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| Irritated ganglion | Nervous system disorders |
|
| Loss of stimulation | Injury, poisoning and procedural complications |
|
| Wound Infection | Infections and infestations |
|
| Dural puncture | Injury, poisoning and procedural complications |
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| Hematoma/Infection | Injury, poisoning and procedural complications |
|
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| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
|
| 12-Month Visit |
|
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