Kansas City, Kansas 66160

  • back Pain

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.


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.


NCT ID:

NCT04730700


Primary Contact:

Principal Investigator
Dawood Sayed, MD
University of Kansas Medical Center

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


Backup Contact:

N/A


Location Contact:

Kansas City, Kansas 66160
United States

Principal Investigator

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 20, 2021

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