Scottsdale, Ariz.-based Phoenix Spine will be one of 20 U.S.-based centers to study the effectiveness of Relievant Medsystems' Intracept procedure for chronic lower back pain.
Here's what you should know.
1. Researchers will enroll up to 150 patients into the study, which aims to compare the procedure to conservative care. They'll primarily measure mean change from baseline to three months post-treatment using the Oswestry Disability Index.
2. The study is building on the recently completed level 1 Smart trial, which showed significant improvements in function and pain paired with decreased opioid use associated with the Intracept procedure.
3. The Intracept procedure uses a transpedicular, minimally invasive approach to reach the basivertebral nerve, where radiofrequency energy is used to ablate the nerve, stopping the transmission of pain signals.
4. The procedure is performed in the ambulatory setting through image guidance. It requires neither stitches nor general anesthesia.