RECRUITING

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

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Conditions

Chronic Low-back Pain

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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.

Quick Facts

Study Start:2020-12-17
Study Completion:2025-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04730700

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \> 18 years old.
  2. * Patients with pain lasting at least 6 months.
  3. * Patients with history of non-radiating low back pain.
  4. * Patient who had two diagnostic medial branch blocks (MBB) with significant (\>50%) improvement on both injections.
  5. * Patient has signed study-specific informed consent.
  6. * Patient has the necessary mental capacity to participate and is physically able to comply with study protocol requirements.
  1. * Patient with low back pain with radiation or involvement of pain going into their legs below their knees.
  2. * Patient did not receive satisfactory relief from diagnostic MBB (\<50% relief).
  3. * Patient is unable to receive radiation exposure.
  4. * Patient is currently pregnant.
  5. * Patient has a current local overlying low back or systemic infection.
  6. * Patient currently receiving or seeking workers compensation, disability remuneration, and/or involved in injury litigation.
  7. * Known or suspected drug or alcohol abuse.
  8. * Diagnosed psychiatric disease (e.g., schizophrenia, major depression, personality disorders) that could interfere with study participation.
  9. * Patient is participating in an investigational study or has been involved in an investigational study within 3 months prior to evaluation for participation.
  10. * Patient has an implanted intrathecal pump or spinal neuromodulation device.
  11. * Patient currently on daily oral morphine equivalent (OME) of 50.

Contacts and Locations

Study Contact

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

Principal Investigator

Dawood Sayed, MD
PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center

Study Locations (Sites)

University of Kansas Medical Center
Kansas City, Kansas, 66160
United States

Collaborators and Investigators

Sponsor: University of Kansas Medical Center

  • Dawood Sayed, MD, PRINCIPAL_INVESTIGATOR, University of Kansas Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-17
Study Completion Date2025-11

Study Record Updates

Study Start Date2020-12-17
Study Completion Date2025-11

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Low-back Pain