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

Last updated: October 18, 2024
Sponsor: University of Kansas Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Conventional Medical Management

Radiofrequency Ablation with MEE

Clinical Study ID

NCT04730700
STUDY00146448
  • Ages > 18
  • All Genders

Study 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

Inclusion

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 tocomply with study protocol requirements.

Exclusion

Exclusion Criteria:

  • Patient with low back pain with radiation or involvement of pain going into theirlegs 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, disabilityremuneration, and/or involved in injury litigation.

  • Known or suspected drug or alcohol abuse.

  • Diagnosed psychiatric disease (e.g., schizophrenia, major depression, personalitydisorders) that could interfere with study participation.

  • Patient is participating in an investigational study or has been involved in aninvestigational 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 Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Conventional Medical Management
Phase:
Study Start date:
December 17, 2020
Estimated Completion Date:
November 30, 2025

Connect with a study center

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

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