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

NCT04730700 | Recruiting FDA Device

• 1 other identifier: STUDY00146448
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Low-back Pain

Outcome Measures

Primary Outcomes (1)

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

  will be compared using an independent samples t-test

  12 months

Secondary Outcomes (1)

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

  12 months

Study Arms (2)

Radiofrequency ablation (RFA) with MEE

ACTIVE COMPARATOR

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

Conventional Medical Management (CMM) Treatment Only

ACTIVE COMPARATOR

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

Interventions

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.

Radiofrequency ablation (RFA) with MEE

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.

Conventional Medical Management (CMM) Treatment Only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

MeSH Terms

Interventions

Radiofrequency Ablation

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Dawood Sayed, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angie Ballew, DC, MS

CONTACT

(913) 945-7420; aballew@kumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: January 29, 2021
• Study Start: December 17, 2020
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: November 13, 2025

Record last verified: 2025-11

Locations

US (1)