20-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 post surgical pain
Study Type
OBSERVATIONAL
Enrollment
30
Implantation with Axium DRG Neurostimulator
Academisch Medisch Centrum
Amsterdam, Netherlands
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).
Time frame: Baseline, 3, 6, 12 and 24-Month Visits
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).
Time frame: 3, 6, 12 and 24-Month Visits
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