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Recruiting

NCT Number: NCT04730700

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location status: Recruiting

Location contact

Principal Investigator

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Radiofrequency Ablation with MEE

Procedure

RFA will be performed in the usual fashion utilizing the MEE instead of the RFA needles routinely used at each institution.

Conventional Medical Management

Behavioral

Conventional medical management (CMM), which may include physical therapy, home exercise programs, pain medication, and other conservative therapies such as back brace, walking aid, and chiropractic care.

Primary outcomes

  1. The mean visual analog scale (VAS) between the two group

    Time frame: 12 months

    will be compared using an independent samples t-test

Secondary outcomes

  1. Observe the incidence of complications associated with MEE while utilizing this device

    Time frame: 12 months

    Number of complications will be analyzed using Independent samples T-Test if there is a normal distribution of complications. In the event of a binary outcome for complications, Chi-square Test will be used.

Study contacts

Contact information is provided by the study sponsor or research team.

Angie Ballew, DC, MS

CONTACT

[email protected]

(913) 945-7420

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Acronym: MEE

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Jan 29, 2021
Registry last updated
Nov 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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