Evaluation of Multi-Tined Expandable Electrode (MEE) Efficacy and Safety in Treatment of Lumbar F… (NCT04730700) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of Multi-Tined Expandable Electrode (MEE) Efficacy and Safety in Treatment of Lumbar Facet Arthropathy by Radiofrequency Neurotomies Compared to Conservative Medical Management.
United States50 participantsStarted 2020-12-17
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The mean visual analog scale (VAS) between the two group