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

NCT02120625 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 8

Last updated 2017-04-28

Study results available
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Summary

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.

Conditions

  • Low Back Pain

Interventions

DEVICE

Lumbar MB RFN

Patients will be placed in a prone position and prepped. The C-arm will be adjusted to establish a true anteroposterior image of the target vertebra. The C-arm will then be rotated until the target point at the base of the SAP is clearly visualized. The Nimbus probe, with the tines (filaments) in the retracted position, will be inserted and advanced to the bony target site using a down the beam approach. The probe hub will be rotated to accomplish a full deployment of the tines with a medial or lateral angular bias, as dictated by the SAP anatomy and angle of entry of the NMEE probe. Motor stimulation at 2 Hz up to 2 volts will be administered (safety check). The lesion site will be anesthetized before the radiofrequency (RF) generator is set to achieve a temperature of 80°C for 80 seconds, following 30 second temperature ramp up. Impedance and power will be recorded.

Sponsors & Collaborators

  • Nimbus Concepts, LLC

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02120625 on ClinicalTrials.gov