Technical Efficacy of a Direction Specific Radiofrequency Device in the Performance of Lumbar Medial Branch Neurotomies

Completed

Conditions studied: Low Back Pain

In brief

The purpose of this study is to document the effectiveness of the Nimbus Multi-tined Expandable Electrode (MEE) Probe in carrying out the heating and ablation (cutting) of the small medial branch nerves that carry pain information from the facet joints. Subjects will be selected, by way of clinical evaluation and response to medial branch blocks, to undergo this procedure of radiofrequency ablation/neurotomies of the medial branches to the specific painful facet joints of the low back in order to relieve pain. This will be carried out with an FDA-approved device using a standard technique that has been accepted throughout the world. The difference in this study is that we will make use of MRIs to image the lesion that is produced and a special EMG study to look at the muscles in the back to document the effectiveness of the device in creating the intended lesion. No other study of this kind has been produced to look at this or any other radiofrequency device in the treatment of low back pain.

Key facts

Study ID

NCT02120625

Run by

Nimbus Concepts, LLC

People needed

8

Starts

2013-12-01

Expected to finish

2015-12-01

Last updated by the study team

2017-04-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients with a low back pain episode greater than three months in duration, unresponsive to non-interventional care, have had a lumbar MRI which is available for review, who have been selected to undergo lumbar medial branch RF lesioning and who have agreed to undergo pre and post procedure EMG and post procedure lumbar magnetic resonance imaging (LMRI).
• Age 18 or greater
• Appropriately selected patients using at least one set of diagnostic medial branch blocks

You may not qualify if…

• Inability to attend EMG, MRI assessments within the defined assessment time windows
• Radicular pain or evidence of neurological compromise in the lower limbs (see clarification above - Target Population).
• Those unable to read English and complete the informed consent process
• Spondylolysis or lytic spondylolisthesis, degenerative spondylolisthesis which is Grade II+ or unstable.
• Systemic inflammatory, toxic, corticosteroid induced or congenital myopathy, or inflammatory arthritis
• Possible pregnancy or other reason that precludes the use of fluoroscopy, MRI, or EMG
• Significant lumbar scoliosis (Cobb angle > 15 degrees).
• Radicular/neurological deficits or focal disc herniation and/or stenosis, with correlating radicular symptoms (defined as pain or paresthesias below the knee; pain reproduction with straight leg raising; leg > back pain with extension/rotation maneuvers; radicular strength, reflex, or sensory changes consistent with their level of nerve root impingement).
• Immunologically suppressed, or has received steroids at any dose daily for > 1 month within last 12 months
• Currently involved in another study or treatment that may affect the outcome of this study
• Evidence of spontaneous activity (denervation potentials) on baseline EMG

Where it is running

• Denver Back Pain Specialists, LLC — Greenwood Village, Colorado, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.