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Study of Multi-Tined Expandable Electrode (MEE) for Chronic Low-back Pain

This study is looking at a new way to treat chronic low-back pain. It compares a procedure called radiofrequency ablation (RFA) using a special needle called a multi-tined expandable electrode (MEE) to standard medical care. RFA uses heat to stop nerves from sending pain signals. Standard medical care can include things like physical therapy, exercise, and pain medicine. You might be able to join if you are over 18, have had low back pain for at least 6 months that doesn't spread to other areas, and have had two specific diagnostic injections that helped your pain by more than 50%. The main goal is to see how much pain relief people experience after 12 months in both groups. The study plans to enroll 50 participants.

Study design
This study is comparing two different treatments for chronic low-back pain. It plans to enroll 50 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months to measure their pain levels.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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.

Recruiting
NAAges 18+InterventionalTreatment
University of Kansas Medical Center
~50 participants
Updated 2025-11-13 on ClinicalTrials.gov
What's tested:Radiofrequency Ablation with MEEConventional Medical Management

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The mean visual analog scale (VAS) between the two group
Measured over 12 months

Conditions

Chronic Low-back Pain

Explore related trials

Chronic low back pain

Where it's being run

1 sites across 1 states
Kansas1

Study leadership

  • Dawood Sayed, MD · PRINCIPAL_INVESTIGATOR · University of Kansas Medical Center

Who to contact

Angie Ballew, DC, MS
[email protected]
(913) 945-7420
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • The mean visual analog scale (VAS) between the two group12 months

    will be compared using an independent samples t-test