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The Principal investigator retired without replacement. Only one patient was enrolled and completed the entire study without adverse events.
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25-SMI-2014 is a post market observational, questionnaire based study to assess the effectiveness of the Axium neurostimulator as a treatment for chronic post surgical groin pain. Within is also a nested feasibility study to assess the clinical utility of a Quantitive Sensory Testing (QST) protocol in the management of the described study group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treated Subjects | All subjects recruited into the main study treated with the Axium neurostimulator |
| |
| QST Group | A sub-set of the main study group who also consent to take part in the Quantitative Sensory Testing based feasibility study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation with the commercially available Axium neurostimulator | Device |
| ||
| QST Testing |
| Measure | Description | Time Frame |
|---|---|---|
| Main Study: Pain Relief - Assessed be Change in Pain Intensity from Pre-Treatment Baseline | Post implantation at; 1, 3 and 6 months | |
| Feasibility Study: To determine subject acceptance of the described QST methodology and protocol; assessed using a 5 point Likert scale | Baseline then Post implantation at; 1, 3 and 6 months |
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Main Study
Inclusion Criteria:
Exclusion Criteria:
Additional Criteria for nested feasibility study
Additional Inclusion Criteria
Additional Exclusion Criteria
1. For sub-study participation only: pain conditions [aside from the post surgical groin pain to be treated], extensive scar tissue, skin conditions, or sensorimotor abnormalities in the areas for QST assessments: the painful groin, the contralateral groin, the ipsilateral arm, and the contralateral hand
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Chronic Post Surgical Groin Pain Patients
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Antonius Ziekenhuis | Nieuwegein | Netherlands |
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| Procedure |
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