This study aims to develop a technical description of lumbar medial branch ablation using the LumbarCool system. The procedure uses cooled radiofrequency (cooled-RF) technology in treating patients with diagnosed lumbar facet joint pain.
This is a prospective, open-label, single center clinical study to be enrolled at George Washington University Medical Center. This study will consist of 10 patients and each patient will be assessed at pre-treatment, pre-discharge, and at 1 and 3 months post treatment. Outcomes to be evaluated include: pain severity, disability, and the occurrence of adverse events.
Study Type
OBSERVATIONAL
Enrollment
10
MAPS Applied Research Center, Inc.
Edina, Minnesota, United States
RECRUITINGConfirm acute safety of the procedure
The primary outcome is to confirm acute safety of the procedure utilizing the neurological exam. The following outcome measures will also be used to confirm there are no safety concerns at one month and 3 months follow-up visits: * Pain intensity using the Numerical Rating Scale (NRS) * Change in medication usage * Assessment of adverse device effects, including neurological exam (light touch/pin prick, strength, straight leg test, gait, heel to toe/straight-line walking, heel to shin) (immediately post procedure, 1 month and 3 months).
Time frame: Baseline to 3 months post procedure.
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