Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04730700
Recruitment Status : Recruiting
First Posted : January 29, 2021
Last Update Posted : May 10, 2021
Sponsor:
Information provided by (Responsible Party):
Dawood Sayed, MD, University of Kansas Medical Center

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.

Condition or disease Intervention/treatment Phase
Chronic Low-back Pain Procedure: Radiofrequency Ablation with MEE Behavioral: Conventional Medical Management Not Applicable

Layout table for study information
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Joint Disorders

Arm Intervention/treatment
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.
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.
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.




Primary Outcome Measures :
  1. The mean visual analog scale (VAS) between the two group [ Time Frame: 12 months ]
    will be compared using an independent samples t-test


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Angie Ballew, DC, MS (913) 945-7420 aballew@kumc.edu

Locations
Layout table for location information
United States, Kansas
University of Kansas Medical Center Recruiting
Kansas City, Kansas, United States, 66160
Contact: Principal Investigator         
Sponsors and Collaborators
University of Kansas Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Dawood Sayed, MD University of Kansas Medical Center
Layout table for additonal information
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

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Joint Diseases
Low Back Pain
Back Pain
Pain
Neurologic Manifestations
Musculoskeletal Diseases