Clinical Trial: Trial Comparing Treatment With SInergy™ System to Conservative Treatment for Chronic Sacroiliac Joint Pain
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Randomized Controlled Trial Comparing Cooled Radiofrequency Denervation to Conservative Treatment as a Treatment for Sacroiliac Joint Pain Using the SInergy™ Syste
Brief Summary: The purpose of this study is to evaluate the effectiveness of cooled radiofrequency denervation of the sacroiliac region using the SInergy System compared to conservative treatment in the treatment of sacroiliac joint pain.
Detailed Summary:
Sponsor: Baylis Medical Company
Current Primary Outcome: Pain status change for sacroiliac region pain intensity assessed using visual analogue scale (VAS) [ Time Frame: 12 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change in bodily pain evaluated using SF-36 Bodily Pain [ Time Frame: 12 months ]
- Change in physical functioning evaluated using SF-36 Physical Function [ Time Frame: 12 months ]
- Change in disability evaluated using Oswestry Disability Index 2.0 [ Time Frame: 12 months ]
- Change in quality of life using the Assessment of Quality of Life (AQOL) [ Time Frame: 12 months ]
Original Secondary Outcome: Same as current
Information By: Baylis Medical Company
Dates:
Date Received: July 6, 2010
Date Started: July 2010
Date Completion:
Last Updated: May 3, 2013
Last Verified: May 2013
