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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 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-11-13

No results posted yet for this 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.

Conditions

  • Chronic Low-back Pain

Interventions

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.

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.

Sponsors & Collaborators

  • University of Kansas Medical Center

    lead OTHER

Principal Investigators

  • Dawood Sayed, MD · University of Kansas Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-17
Primary Completion
2026-11-30
Completion
2026-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04730700 on ClinicalTrials.gov