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)

• ClinicalTrials.gov Identifier: NCT04730700
• Recruitment Status: Recruiting
• First Posted: January 29, 2021
• Last Update Posted: May 10, 2021
• Sponsor: University of Kansas Medical Center
• Information provided by (Responsible Party): Dawood Sayed, MD, University of Kansas Medical Center

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.

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

Contact: Angie Ballew, DC, MS; (913) 945-7420; aballew@kumc.edu

Locations

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

• Principal Investigator: Dawood Sayed, MD; University of Kansas Medical Center

More 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
• Last Update Posted: May 10, 2021
• Last Verified: May 2021

• 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:

Joint Diseases; Low Back Pain; Back Pain; Pain; Neurologic Manifestations; Musculoskeletal Diseases