A Post Market Observational Cohort Study to Assess the Performance of the Spinal Modulation Dorsal Root Ganglion Stimulator System for the Management of Chronic Post Surgical Pain
Sponsor study identifier
observational
30
1 country
1
Study Start
June 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2017
Actual (reported)Study Completion
February 2017
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2013
Date type not reportedThis date has not been verified as actual or estimated.
January 7, 2015
Actual (reported)January 9, 2015
Actual (reported)February 2017
Actual (reported)February 2017
Actual (reported)April 29, 2019
Actual (reported)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, 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).
3, 6, 12 and 24-Month Visits
All eligible subjects recruited and treated with the Axium Neurostimulator
Implantation with Axium DRG Neurostimulator
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patient suffering from chronic post surgical pain
Academisch Medisch Centrum
Amsterdam, Netherlands
30 participants (actual enrollment reported by the registry).
First Submitted
January 7, 2015
First Posted
January 9, 2015
Study Start
June 2013
Date type not reportedThis date has not been verified as actual or estimated.
Does a Multimodal no-Compression Suture Technique of the Intercostal Space Reduce Chronic Post-Thoracotomy Pain?
Contact the study team to confirm eligibility.
Primary Completion
February 2017
Actual (reported)Study Completion
February 2017
Actual (reported)Last Updated
April 29, 2019
Results First Posted
April 29, 2019
Record last verified: 2019-01
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Source: ClinicalTrials.gov.
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