About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Radiofrequency Ablation with MEE
Procedure/SurgeryRFA will be performed in the usual fashion utilizing the MEE instead of the RFA needles routinely used at each institution.
Conventional Medical Management
BehavioralConventional 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.
Treatment groups
Trial outcomes
Primary outcomes
The mean visual analog scale (VAS) between the two group
will be compared using an independent samples t-test
Secondary outcomes
Observe the incidence of complications associated with MEE while utilizing this device
Number of complications will be analyzed using Independent samples T-Test if there is a normal distribution of complications. In the event of a binary outcome for complications, Chi-square Test will be used.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.