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.
| NCT ID | NCT04730700 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Kansas Medical Center |
| Condition | Chronic Low-back Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2020-12-17 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2020-12-17 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Dawood Sayed, MD
PRINCIPAL INVESTIGATOR
University of Kansas Medical Center
Frequently Asked Questions
Who can join the NCT04730700 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Low-back Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04730700 currently recruiting?
Yes, NCT04730700 is actively recruiting participants. Contact the research team at aballew@kumc.edu for enrollment information.
Where is the NCT04730700 trial being conducted?
This trial is being conducted at Kansas City, United States.
Who is sponsoring the NCT04730700 clinical trial?
NCT04730700 is sponsored by University of Kansas Medical Center. The principal investigator is Dawood Sayed, MD at University of Kansas Medical Center. The trial plans to enroll 50 participants.