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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Chronic Low-back Pain

Intervention / Treatment
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* Procedure: Radiofrequency Ablation with MEE
* Behavioral: Conventional Medical Management


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Radiofrequency ablation (RFA) with MEE<br>Radiofrequency ablation involves a minimally invasive procedural technique. It uses radiofrequency waves to burn the nerve causing pain. This nerve will no longer be able to send pain signals to your brain. For this study, the multi-tined expandable electrode needle will be used. This needle will result in a larger treatment area. This may result in better pain relief and longer lasting pain relief. If you undergo the radiofrequency ablation procedure you will have pain medication injected where the ablation will be done. The procedure will take about 20 mins to complete. You will be allowed to go home afterward. | Procedure: Radiofrequency Ablation with MEE<br>* RFA will be performed in the usual fashion utilizing the MEE instead of the RFA needles routinely used at each institution.<br>|
| Active Comparator: Conventional Medical Management (CMM) Treatment Only<br>Your current standard of care treatment may already consist of some CMM therapies. Standard of care includes a variety of intervention types such as medication, physical therapy, home exercise programs, back brace, walking aid, and chiropractic care. | Behavioral: Conventional Medical Management<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean visual analog scale (VAS) between the two group | will be compared using an independent samples t-test | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observe the incidence of complications associated with MEE while utilizing this device | Number of complications will be analyzed using Independent samples T-Test if there is a normal distribution of complications. In the event of a binary outcome for complications, Chi-square Test will be used. | 12 months |