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
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2020-12-17
2026-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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University of Kansas Medical Center
OTHER
Responsible Party
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Dawood Sayed, MD
Study Principal Investigator
Principal Investigators
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Dawood Sayed, MD
Role: PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center
Locations
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University of Kansas Medical Center
Kansas City, Kansas, United States
Countries
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Central Contacts
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Facility Contacts
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Principal Investigator
Role: primary
Other Identifiers
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STUDY00146448
Identifier Type: -
Identifier Source: org_study_id