Technical Description of Cooled Radiofrequency Ablation of Lumbar Medial Branches for the Treatment of Lumbar Facet Pain
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.
Lumbar Facet Joint Pain
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Technical Description of Cooled Radiofrequency Ablation of Lumbar Medial Branches for the Treatment of Lumbar Facet Pain|
- Confirm acute safety of the procedure [ Time Frame: Baseline to 3 months post procedure. ] [ Designated as safety issue: Yes ]
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).
|Study Start Date:||August 2012|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01590004
|United States, Maryland|
|Metro Orthopedics and Sports Therapy|
|Silver Spring, Maryland, United States, 20910|
|Principal Investigator:||Mehul J Desai, MD||International Spine, Pain and Performance Center|