Parallel Versus Perpendicular Technique for Lumbar Medial Branch Radiofrequency Neurotomy

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT03912519
Status
Enrolling By Invitation

Conditions

  • Back Pain Without Radiation
  • Low Back Pain
  • Lumbar Radiofrequency Neurotomy

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Parallel placement of 16 gauge electrodes — PROCEDURE
    Parallel technique
  • Perpendicular placement with 22 gauge electrodes — PROCEDURE
    Perpendicular technique

Study Details

Low back pain is a leading cause of disability worldwide. The lumbar zygapophyseal joints (z-joints) are estimated to be the source of low back pain between 10% and 40% of the time. Observational studies have shown that lumbar medial branch radiofrequency neurotomy (LMBRFN) can be an effective treatment for z-joint low back pain. Nonetheless, other publications such as the Cochrane collaboration systematic review and the "Minimal Interventional Treatments for Participants with Chronic Low Back Pain" or "MINT" randomized controlled trial conclude that LMBRFN is not efficacious. These discrepancies in the literature may be due to differences in patient selection and procedural technique. This study aims to employ patient selection via dual medial branch block resulting in at least 80% relief on both occasions. Using this rather strict enrollment criteria, the aim of the study is to then compare LMBRFN utilizing 16 gauge needles via the "parallel" approach as endorsed by Spine Intervention Society guidelines to LMBRFN performed with 22 gauge needles and another commonly employed "perpendicular" technique similar to that approach used for medial branch blocks. The primary outcome of the study will be to determine if there is a difference in the percentage of patients with lumbar facet pain who achieve moderate or good response (improvement of Numeric Pain Rating Scale of at least 50% or 80%) or in the duration of effect (median duration of moderate or good response in those with positive outcome) between these two groups.

Key Dates

Start date
Aug 21, 2019
Status verified
Jun 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
132 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Parallel placement of 16 gauge electrodes
    Parallel Group will undergo radiofrequency ablation via the approach described in Spine Intervention Practice Guidelines via 16 gauge electrodes. Specifically, the target nerve will be targeted with a parallel approach so as the electrode lay parallel to the nerves location within the sulcus formed by the neck of superior articular process and transverse process (or sacral ala for L5) cephalad to the point it is covered by the mamillo-accessory ligament.
  • Active Comparator: Perpendicular placement with 22 gauge electrodes
    Perpendicular Group will undergo radiofrequency ablation via the approach described in Spine Intervention Society Practice Guidelines for medial branch blocks, using a 22 gauge electrode. Specifically, the target nerve will be targeted with a perpendicular approach so as the tip of electrode contact the nerve at some point of it course along the sulcus formed by the neck of superior articular process and transverse process (or sacral ala for L5) cephalad to the point it is covered by the mamillo-accessory ligament.

Primary Outcome Measure

Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), Global Impression of Change [ Time Frame: Baseline to 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37212-

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