Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

University of Kansas Medical Center
Kansas City, Kansas 66160
Contact:
Principal Investigator

More Details

Status
Recruiting
Sponsor
University of Kansas Medical Center

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.