RecruitingNot ApplicableNCT04730700

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

Sponsor

University of Kansas Medical Center

Enrollment

50 participants

Start Date

Dec 17, 2020

Study Type

INTERVENTIONAL

Conditions

Chronic Low-back Pain

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria6

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 Criteria11

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.

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Interventions

PROCEDURERadiofrequency Ablation with MEE

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

BEHAVIORALConventional 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.