Evaluation of Multi-Tined Expandable Electrode (MEE) Efficacy and Safety in Treatment of Lumbar Facet Arthropathy by Radiofrequency Neurotomies Compared to Conservative Medical Management. (MEE)
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ClinicalTrials.gov Identifier: NCT04730700 |
Recruitment Status :
Recruiting
First Posted : January 29, 2021
Last Update Posted : May 10, 2021
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Condition or disease | Intervention/treatment | Phase |
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Chronic Low-back Pain | Procedure: Radiofrequency Ablation with MEE Behavioral: Conventional Medical Management | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Evaluation of Multi-Tined Expandable Electrode (MEE) Efficacy and Safety in Treatment of Lumbar Facet Arthropathy by Radiofrequency Neurotomies Compared to Conservative Medical Management. |
Actual Study Start Date : | December 17, 2020 |
Estimated Primary Completion Date : | November 2023 |
Estimated Study Completion Date : | November 2023 |

Arm | Intervention/treatment |
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Active Comparator: Radiofrequency ablation (RFA) with MEE
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.
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Procedure: Radiofrequency Ablation with MEE
RFA will be performed in the usual fashion utilizing the MEE instead of the RFA needles routinely used at each institution. |
Active Comparator: Conventional Medical Management (CMM) Treatment Only
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.
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Behavioral: Conventional 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. |
- The mean visual analog scale (VAS) between the two group [ Time Frame: 12 months ]will be compared using an independent samples t-test
- Observe the incidence of complications associated with MEE while utilizing this device [ Time Frame: 12 months ]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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04730700
Contact: Angie Ballew, DC, MS | (913) 945-7420 | aballew@kumc.edu |
United States, Kansas | |
University of Kansas Medical Center | Recruiting |
Kansas City, Kansas, United States, 66160 | |
Contact: Principal Investigator |
Principal Investigator: | Dawood Sayed, MD | University of Kansas Medical Center |
Responsible Party: | Dawood Sayed, MD, Study Principal Investigator, University of Kansas Medical Center |
ClinicalTrials.gov Identifier: | NCT04730700 |
Other Study ID Numbers: |
STUDY00146448 |
First Posted: | January 29, 2021 Key Record Dates |
Last Update Posted: | May 10, 2021 |
Last Verified: | May 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | No |
Joint Diseases Low Back Pain Back Pain |
Pain Neurologic Manifestations Musculoskeletal Diseases |