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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Low-back Pain
• Intervention / Treatment: Procedure: Radiofrequency Ablation with MEE; Behavioral: Conventional Medical Management

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Angie Ballew, DC, MS; Phone Number: (913) 945-7420; Email: aballew@kumc.edu

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Medical Center
      • Contact: Principal Investigator

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Radiofrequency ablation (RFA) with MEE; Radiofrequency ablation involves a minimally invasive procedural technique. It uses radiofrequency waves to burn the nerve causing pain. This nerve will no longer be able to send pain signals to your brain. For this study, the multi-tined expandable electrode needle will be used. This needle will result in a larger treatment area. This may result in better pain relief and longer lasting pain relief. If you undergo the radiofrequency ablation procedure you will have pain medication injected where the ablation will be done. The procedure will take about 20 mins to complete. You will be allowed to go home afterward.	Procedure: Radiofrequency Ablation with MEE; RFA will be performed in the usual fashion utilizing the MEE instead of the RFA needles routinely used at each institution.
Active Comparator: Conventional Medical Management (CMM) Treatment Only; Your current standard of care treatment may already consist of some CMM therapies. Standard of care includes a variety of intervention types such as medication, physical therapy, home exercise programs, back brace, walking aid, and chiropractic care.	Behavioral: Conventional Medical Management; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The mean visual analog scale (VAS) between the two group	will be compared using an independent samples t-test	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Observe the incidence of complications associated with MEE while utilizing this device	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.	12 months

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Investigators: Principal Investigator: Dawood Sayed, MD, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2020
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: December 22, 2020
• First Submitted That Met QC Criteria: January 28, 2021
• First Posted (Actual): January 29, 2021

Study Record Updates

• Last Update Posted (Estimated): November 13, 2025
• Last Update Submitted That Met QC Criteria: November 11, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Back Pain; Joint Diseases; Low Back Pain; Therapeutics; Surgical Procedures, Operative; Ablation Techniques; Radiofrequency Therapy; Radiofrequency Ablation
• Other Study ID Numbers: STUDY00146448

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No