Chronic Low-back Pain
Conditions
Brief summary
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.
Interventions
PROCEDURERadiofrequency Ablation with MEE
RFA will be performed in the usual fashion utilizing the MEE instead of the RFA needles routinely used at each institution.
BEHAVIORALConventional 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.
Sponsors
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The mean visual analog scale (VAS) between the two group | 12 months | will be compared using an independent samples t-test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Observe the incidence of complications associated with MEE while utilizing this device | 12 months | 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. |
Countries
United States
Contacts
Primary ContactAngie Ballew, DC, MS
Outcome results
None listed