Back to resultsEvaluation of Multi-Tined Expandable Electrode (MEE) Efficacy and Safety in Treatment of Lumbar Facet Arthropathy by Radiofrequency Neurotomies Compared to Conservative Medical Management. (MEE)
Primary Purpose
Chronic Low-back Pain
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Radiofrequency Ablation with MEE
Conventional Medical Management
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low-back Pain
Eligibility Criteria
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.
Sites / Locations
- University of Kansas Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Radiofrequency ablation (RFA) with MEE
Conventional Medical Management (CMM) Treatment Only
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
The mean visual analog scale (VAS) between the two group
will be compared using an independent samples t-test
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04730700
First Posted
December 22, 2020
Last Updated
May 6, 2021
Sponsor
University of Kansas Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04730700
Brief 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.
Acronym
MEE
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 17, 2020 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kansas Medical Center
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Radiofrequency ablation (RFA) with MEE
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Conventional Medical Management (CMM) Treatment Only
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency Ablation with MEE
Intervention Description
RFA will be performed in the usual fashion utilizing the MEE instead of the RFA needles routinely used at each institution.
Intervention Type
Behavioral
Intervention Name(s)
Conventional Medical Management
Intervention Description
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.
Primary Outcome Measure Information:
Title
The mean visual analog scale (VAS) between the two group
Description
will be compared using an independent samples t-test
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Observe the incidence of complications associated with MEE while utilizing this device
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angie Ballew, DC, MS
Phone
(913) 945-7420
Email
aballew@kumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawood Sayed, MD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Multi-Tined Expandable Electrode (MEE) Efficacy and Safety in Treatment of Lumbar Facet Arthropathy by Radiofrequency Neurotomies Compared to Conservative Medical Management.
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