💬In plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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