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)
Loading locations...
Similar Trials
Active, not recruiting
Not Applicable
Excision Followed by Radiofrequency Ablation for Breast CancerBreast CancerNCT01153035University of Arkansas104
Completed
Not Applicable
Multi-electrode Radiofrequency Balloon Catheter Use for the Isolation of the Pulmonary Veins.Paroxysmal Atrial FibrillationNCT03437733Biosense Webster, Inc.98
Unknown
Not Applicable
Radiofrequency Ablation Combined With Chemotherapy for Pulmonary TumorsPulmonary MetastasesNSCLCNCT01105182The First Affiliated Hospital of Guangzhou Medical University48
Completed
Phase 4
Achilles Tendinosis Study; Comparison of Radiofrequency to Surgical MicroDebridementAchilles PainAchilles TendinosisHeel PainNCT00534781ArthroCare Corporation60
Not yet recruiting
Not Applicable
Observation on the Efficacy of Radiofrequency Ablation for Patients With Moderate to Severe Gastric Atrophy With Enterosis With or Without Atrophy of Intraepithelial Neoplasia: An Observational StudyAtrophic GastritisNCT06751212Xiuli Zuo62
