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Compares treatment options for Chronic Low-back Pain
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.
ClinicalTrials.gov ID: NCT04730700
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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.
You likely 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Kansas City, Kansas, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kansas City, Kansas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.