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

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT04730700
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Kansas Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Dawood Sayed, MD
Principal Investigator Affiliation University of Kansas Medical Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Chronic Low-back Pain
Arms & Interventions

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

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Kansas Medical Center, Kansas City, Kansas

Status

Recruiting

Address

University of Kansas Medical Center

Kansas City, Kansas, 66160

Site Contact

Principal Investigator

[email protected]

(913) 945-7420

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