Evaluating a new needle technique for treating chronic low-back pain
Evaluation of Multi-Tined Expandable Electrode (MEE) Efficacy and Safety in Treatment of Lumbar Facet Arthropathy by Radiofrequency Neurotomies Compared to Conservative Medical Management.
This study is testing a new needle technique for treating chronic low-back pain to see if it works better than regular medical care for adults who have been in pain for at least six months.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Kansas Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Kansas City, Kansas) |
| Trial ID | NCT04730700 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the efficacy and safety of a multi-tined expandable electrode (MEE) used in radiofrequency neurotomies against conventional medical management for patients suffering from chronic low-back pain. Participants will be adults over 18 years old who have experienced non-radiating low back pain for at least six months and have shown significant improvement from diagnostic medial branch blocks. The study will assess patient outcomes following the intervention to determine the effectiveness of the MEE technique compared to standard care.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a history of non-radiating low back pain lasting at least six months and who have responded positively to diagnostic medial branch blocks.
Not a fit: Patients with low back pain that radiates into their legs or those who did not experience satisfactory relief from diagnostic medial branch blocks may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from chronic low-back pain.
How similar studies have performed: Other studies have shown promising results with radiofrequency ablation techniques, but the use of the multi-tined expandable electrode is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Kansas City, Kansas
- University of Kansas Medical Center — Kansas City, Kansas, United States (Recruiting)
Study contacts
- Principal investigator: Dawood Sayed, MD — University of Kansas Medical Center
- Study coordinator: Angie Ballew, DC, MS
- Email: aballew@kumc.edu
- Phone: (913) 945-7420
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.