At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Institutional Review Board of Tri-Service General Hospital, National Defense Medical Center
In Brief
An observational study evaluating Cone beam computed tomography for Failed Back Surgery Syndrome and Spinal Stenosis. Completed, enrolled 30 participants across 1 site.
Detailed Summary
Conventional epidurography (CE) is thought to have insufficient usefulness on percutaneous epidural adhesiolysis (PEA). The investigators aimed to evaluate the association between the outcome of PEA and three dimensional-rotational epidurography (3D-RE). The investigators performed 30 PEA in 26 patients, and evaluated their post-PEA image findings. Two independent clinicians categorized and recorded the occurrence of contrast at intra-canal ventral and extra-foraminal regions on CE; and contrast at dorsal canal (DC), ventral canal (VC), dorsal foramen (DF), and ventral foramen (VF) on 3D-RE. Reproducibility was assessed using intra-class correlation coefficients (ICCs). The symptom relief after one month for the patients receiving PEA and the contrast distribution patterns of CE and 3D-RE and were determined.
Study Details
Timeline
Interventions
The contrast agent (Omnipaque, GE Healthcare, Ireland) was instilled to confirm the epidural space. With use of a calibrated angiographic C-arm system and a postprocessing workstation, we acquired volume data sets from two dimensional digital projection images obtained to reconstruct the 3D-RE during a C-arm rotation around the patient axis.