Comparing two techniques for treating low back pain with radiofrequency neurotomy
Randomized Trial Comparing Parallel Versus Perpendicular Technique for Lumbar Medial Branch Radiofrequency Neurotomy
This study is testing which of two different needle techniques for treating low back pain works better to help patients feel less pain and move more easily.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 132 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT03912519 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of two different techniques for lumbar medial branch radiofrequency neurotomy (LMBRFN) in patients suffering from low back pain. Participants will be selected based on their response to lumbar medial branch blocks, ensuring they experience significant pain relief before undergoing the procedure. The study will compare the outcomes of using 16 gauge needles with a parallel approach versus 22 gauge needles with a perpendicular approach. The goal is to determine which technique provides better pain relief and functional improvement for patients with z-joint related low back pain.
Who should consider this trial
Good fit: Ideal candidates are individuals over 40 years old with chronic low back pain who have not responded adequately to physical therapy and pain medications.
Not a fit: Patients whose primary complaint is lumbar radiculopathy or those receiving compensation for their pain treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients suffering from chronic low back pain.
How similar studies have performed: While there are conflicting reports on the efficacy of LMBRFN, this study's approach of strict patient selection and technique comparison may provide new insights into its effectiveness.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Byron Schneider, MD — Vanderbilt University Medical Center
- Study coordinator: Byron Schneider, MD
- Email: byron.j.schneider@vumc.org
- Phone: 615-322-0738
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.