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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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

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.

Study details
    Chronic Low-back Pain

NCT04730700

University of Kansas Medical Center

25 August 2025

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