National Harbor, Md.—A minimally invasive interventional pain procedure for the treatment of lumbar spinal stenosis has shown statistically significant efficacy and a strong safety profile at one year, according to the results of a new prospective, multicenter study.
The MILD surgical procedure reduces the degree of central canal stenosis by removing ligament and small amounts of lamina using a fluoroscopically guided, percutaneously placed cannula. The procedure is performed under local anesthesia with moderate sedation. According to the investigators, led by Timothy Deer, MD, of the Center for Pain Relief, Charleston, W. Va., the dearth of data at one year for spine procedures speaks to the importance of the new study.
The trial’s results included data for 170 procedures performed in the first phase of the MILD trial (N=58), completed last year. Improved outcomes in the current study included a significant reduction in pain (defined as ≥40%) in 79% of patients, as measured by score change on the visual analog scale (a mean score of 4.5 from a baseline score of 7.4); significant improvements in function as measured by score change on the Oswestry Disability Index, in 71% of patients (a decrease from a mean score of 48.6 to 36.7); clinically significant improvements for pain and function on the Zuhrich Claudication Questionnaire; and statistically significant improvements in patient satisfaction as measured by score change on the 12-Item Short Form survey.
No serious adverse events related to either the device or procedure were reported.
The study results were presented at the recent annual meeting of the American Academy of Pain Medicine.