Recruiting

MEE vs. Conservative Management

Sponsor:

University of Kansas Medical Center

Code:

NCT04730700

Conditions

Chronic Low-back Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Radiofrequency Ablation with MEE

Conventional Medical Management

Study Details

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.

Conditions

Chronic Low-back Pain

Study ID

NCT04730700

Start date

Dec 17, 2020

Status verified date

Nov, 2025

Completion date

Nov 30, 2026

Anticipated

Primary completion date

Nov 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

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 measure

  • The mean visual analog scale (VAS) between the two group [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Angie Ballew, DC, MS

(913) 945-7420aballew@kumc.edu

Locations

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

More Information

Sponsor

University of Kansas Medical Center

Last update posted

Nov 13, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2025-11-13.