Evaluation of Multi-Tined Expandable Electrode (MEE) Efficacy and Safety in Treatment of Lumbar Facet Arthropathy by Radiofrequency Neurotomies Compared to Conservative Medical Management.

Chronic Low-back Pain Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04730700
• Other study ID #: STUDY00146448
• Status: Recruiting
• Phase: N/A
• Start date: December 17, 2020
• Est. completion date: November 2023

Study information

• Verified date: May 2021
• Source: University of Kansas Medical Center
• Contact: Angie Ballew, DC, MS
• Phone: (913) 945-7420
• Email: aballew[@]kumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Low-back Pain
• Joint Diseases
• Low Back Pain

Intervention

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.

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.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The mean visual analog scale (VAS) between the two group	will be compared using an independent samples t-test	12 months
Secondary	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.	12 months