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 now · Not applicable
Conditions studied: Chronic Low-back Pain
In brief
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.
Key facts
- Study ID
- NCT04730700
- Run by
- University of Kansas Medical Center
- People needed
- 50
- Starts
- 2020-12-17
- Expected to finish
- 2026-11-30
- Last updated by the study team
- 2025-11-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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.
Where it is running
- University of Kansas Medical Center — Kansas City, Kansas, United States (enrolling)
Full record on ClinicalTrials.gov
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