What this study is
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.
What's being tested
- Radiofrequency Ablation with MEE
Intervention · PROCEDURE
RFA will be performed in the usual fashion utilizing the MEE instead of the RFA needles routinely used at each institution.
- Conventional Medical Management
Intervention · BEHAVIORAL
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.
Study details
- Sponsor
- University of Kansas Medical Center
- Conditions
- Chronic Low-back Pain
- Enrolling
- 50 people
- Starts
- 2020-12-17
- Est. completion
- 2026-11-30
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Kansas Medical Center
Kansas City, Kansas, United States
- Principal Investigator · Contact
Recruiting
Study team
Sponsor
University of Kansas Medical Center
Study ID STUDY00146448
Principal investigator
Dawood Sayed, MD
University of Kansas Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.