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NCT04730700NARecruiting

Evaluation of Multi-Tined Expandable Electrode (MEE) Efficacy and Safety in Treatment of Lumbar Facet Arthropathy by Radiofrequency Neurotomies Compared to Conservative Medical Management.

University of Kansas Medical Center

Start Date

12/17/2020

Completion Date

11/30/2026

Summary

The purpose of this study is to better understand how people feel after a radiofrequency ablation standard of care surgery using a different type of needle (multi-tined expandable electrode/MEE) in comparison to receiving conventional medical management (CMM) techniques.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Age \> 18 years old. * Patients with pain lasting at least 6 months. * Patients with history of non-radiating low back pain. * Patient who had two diagnostic medial branch blocks (MBB) with significant (\>50%) improvement on both injections. * Patient has signed study-specific informed consent. * Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements. Exclusion Criteria: * Patient with low back pain with radiation or involvement of pain going into their legs below their knees. * Patient did not receive satisfactory relief from diagnostic MBB (\<50% relief). * Patient is unable to receive radiation exposure. * Patient is currently pregnant. * Patient has a current local overlying low back or systemic infection. * Patient currently receiving or seeking workers compensation, disability remuneration, and/or involved in injury litigation. * Known or suspected drug or alcohol abuse. * Diagnosed psychiatric disease (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation. * Patient is participating in an investigational study or has been involved in an investigational study within 3 months prior to evaluation for participation. * Patient has an implanted intrathecal pump or spinal neuromodulation device. * Patient currently on daily oral morphine equivalent (OME) of 50.

Interventions

PROCEDURE

Radiofrequency Ablation with MEE

BEHAVIORAL

Conventional Medical Management

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Conditions

Chronic Low-back Pain

Locations

University of Kansas Medical Center

Kansas City, Kansas 66160

United States