NCT04730700RecruitingNot 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.
University of Kansas Medical Center2 sites in 1 country50 target enrollmentStarted: December 17, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- The mean visual analog scale (VAS) between the two group
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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.
Outcomes
Primary Outcomes
The mean visual analog scale (VAS) between the two group
Time Frame: 12 months
will be compared using an independent samples t-test
Secondary Outcomes
- Observe the incidence of complications associated with MEE while utilizing this device(12 months)
Investigators
Dawood Sayed, MD
Study Principal Investigator
University of Kansas Medical Center
Study Sites (2)
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