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.
Study Type
OBSERVATIONAL
Enrollment
1
St Antonius Ziekenhuis
Nieuwegein, Netherlands
Main Study: Pain Relief - Assessed be Change in Pain Intensity from Pre-Treatment Baseline
Time frame: 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
Time frame: Baseline then Post implantation at; 1, 3 and 6 months
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