Parallel Versus Perpendicular Technique for Lumbar Medial Branch Radiofrequency Neurotomy

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Apr 9, 2019

Keywords

ClinConnect Summary

This clinical trial is studying two different techniques for a treatment called lumbar medial branch radiofrequency neurotomy (LMBRFN), which is used to help relieve low back pain that comes from specific joints in the lower spine. Researchers want to find out if using different types of needles and approaches (called “parallel” and “perpendicular”) makes a difference in how well patients respond to the treatment. The goal is to see which technique provides better pain relief and for how long.

To participate in the trial, you need to be over 40 years old and have been experiencing low back pain for at least two months that hasn’t improved with physical therapy or pain medication. You also need to show significant improvement (at least 80%) after two specific tests called lumbar medial branch blocks. If you qualify and decide to join, you’ll receive one of the two treatment techniques and will attend follow-up appointments to monitor your progress. It's important to know that this trial has strict criteria for participation to ensure the best results, and it aims to help determine the most effective method for treating low back pain.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • aged \> 40, capable of understanding and providing consent in English, capable of complying with the outcome instruments used, capable of attending all planned follow up visits
• • unilateral or bilateral low back pain of at least 4/10 on Numeric Pain Rating Scale (NPRS) present for at least 2 months that has failed to adequately respond to at least 6 weeks of physical therapy and oral pain medication
• • at least 80% improvement on two consecutive lumbar medial branch blocks of no more than a total of 4 lumbar facet joints
• • beyond the above stated criteria, the decision to initiate the process of a first medial branch block is based on clinical decision making of the treating physician
• • Patient consents to treatment in a shared decision-making process with the treating physician.
• Exclusion Criteria:
• • Those whose primary complain is lumbar radiculopathy
• • Those receiving remuneration for their pain treatment (e.g., disability, worker's compensation).
• • Those involved in active litigation relevant to their pain.
• • Those unable to read English and complete the assessment instruments.
• • Those unable to attend follow up appointments
• • The patient is incarcerated.
• • History of prior lumbar fusion
• • Progressive motor deficit, and/or clinical signs of cauda equina or polyradiculopathy
• • History of lumbar steroid injection (epidural steroid injection, sacroiliac joint steroid injection, lumbar facet steroid injection) within the prior 3 months.
• • Possible pregnancy or other reason that precludes the use of fluoroscopy.
• • Allergy to contrast media or local anesthetics.
• • BMI\>40.
• • Active Systemic inflammatory arthritis (e.g., rheumatoid arthritis, ankylosing spondylitis, lupus).
• • Active infection or treatment of infection with antibiotics within the past 7 days.
• • Medical conditions causing significant functional disability (e.g., stroke, COPD)
• • Chronic widespread pain or somatoform disorder (e.g. fibromyalgia).
• • Addictive behavior, severe clinical depression, or psychotic features.