Comparative Effectiveness of Two Different Approaches to Radiofrequency Ablation of Lumbar Medial Branch Nerves

Study Purpose

The purpose of this voluntary research study is to determine whether the parasagittal approach to lumbar medial branch (LMB) nerve radio frequency ablation (RFA) will have greater efficacy than the traditional approach to lumbar medial branch nerve radio frequency ablation.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Bilateral equally intense axial low back pain. 2. Pain duration of ≥ 6 months. 3. Three-day average NRS scores of ≥ 3/10. 4. Age greater than 18 years. 5. Failure of conservative treatment, including nonsteroidal anti-inflammatory medications and physical therapy. 6. Positive response to a series of two bilateral diagnostic lumbar medial branch nerve blocks (≥ 80% pain relief). This is the current standard of care.

Exclusion Criteria:

1. Radicular pain below the knee. 2. Systemic infection or localized infection at the anticipated introducer entry site. 3. Pregnancy. 4. Allergy to Lidocaine. 5. Bleeding dyscrasias. 6. Patients unable to give informed consent. 7. History of lumbar spine surgery at the affected levels. 8. History of previous bilateral lumbar RFA of medial branches within the past six months. 9. Significant comorbid somatization or widespread pain with central sensitization. 10. Secondary gain identified due to ongoing legal proceedings or worker's compensation. 11. Cognitive impairment. 12. Any pre-existing condition at the discretion of the provider that may confound interpretation of results -

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06283628
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Milton S. Hershey Medical Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Yakov Vorobeychik, MD PhD
Principal Investigator Affiliation	Professor, Department of Anesthesiology
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Lumbar Spondylosis

Additional Details

To determine whether the parasagittal approach to lumbar medial branch (LMB) nerve radiofrequency ablation (RFA) will have greater efficacy than the traditional approach to lumbar medial branch nerve radiofrequency ablation. This will be accomplished by comparing the results between the newly proposed parasagittal approach and the traditional approach of medial branch RFA done on the same patient (different sites) with bilateral low back pain (LBP). Traditional approach: The electrode is introduced at a 15-20 degrees' ipsilateral oblique angle to the sagittal plane toward the junction of the superior articular process (SAP) and transverse process (TP) of the vertebral body to target the traversing medial branch nerve. The reason for the proposed angle is to avoid the mamillo-accessory ligament (MAL) that may be ossified in up to 10% of the normal spine and, in such cases, potentially prevent proper coagulation of the medial branch nerve during the RFA procedure. Parasagittal (new) approach: Recently, Tran et al. showed that MAL is located more dorsally than it was thought earlier and, therefore, can't interfere with nerve coagulation during the RFA. Consequently, they proposed abandoning the 20-degree angle used for the traditional approach and placing the radiofrequency cannula parasagittally and more dorsally. It is proposed that, in order to achieve maximum nerve coagulation, the electrode should be placed as parallel to the nerve as possible, and placing it parasagittally helps achieve this goal. The remainder of the procedure does not differ from the traditional method.

Arms & Interventions

Arms

Active Comparator: Subjects with traditional approach on the right side and parasagittal approach on the left side.

Patients will undergo bilateral RFA; the right side will be done following the traditional approach, and the left side will be done following the parasagittal approach. Traditional approach is done by placing the electrode at a 20 degrees' ipsilateral oblique angle to the sagittal plane toward the junction of the superior articular process and transverse process of the vertebral body to target the traversing medial branch nerve. The reason for the proposed angle is to avoid the mamillo-accessory ligament that may be ossified in up to 10% of the normal spine and potentially prevent proper coagulation of the medial branch nerve during the RFA procedure. Parasagittal (new) approach: is performed by placing the RF cannula parasagittally and more dorsally. To achieve maximum nerve coagulation, the electrode should be placed as parallel to the nerve as possible, and placing it parasagittally helps achieve this goal. The remainder of the procedure does not differ from the traditional method.

Active Comparator: Subjects with traditional approach on the left side and parasagittal approach on the right side.

Patients will undergo bilateral RFA; the left side will be done following the traditional approach, and the right side will be done following the parasagittal approach. Traditional approach is done by placing the electrode at a 20 degrees' ipsilateral oblique angle to the sagittal plane toward the junction of the superior articular process and transverse process of the vertebral body to target the traversing medial branch nerve. The reason for the proposed angle is to avoid the mamillo-accessory ligament that may be ossified in up to 10% of the normal spine and potentially prevent proper coagulation of the medial branch nerve during the RFA procedure. Parasagittal (new) approach: is performed by placing the RF cannula parasagittally and more dorsally. To achieve maximum nerve coagulation, the electrode should be placed as parallel to the nerve as possible, and placing it parasagittally helps achieve this goal. The remainder of the procedure does not differ from the traditional method.

Interventions

Procedure: - Radiofrequency ablation of lumbar medial branch nerves.

Traditional approach: The electrode is introduced at a 15-20 degrees' ipsilateral oblique angle to the sagittal plane toward the junction of the superior articular process (SAP) and transverse process (TP) of the vertebral body to target the traversing medial branch nerve. Parasagittal (new) approach: The RF cannula is placed parasagittally and more dorsally. The remainder of the procedure does not differ from the traditional method.

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Penn State Hershey College of Medicine, Hershey, Pennsylvania

Status

Address

Penn State Hershey College of Medicine

Hershey, Pennsylvania, 17033

Site Contact

Nancy Ruth Jarbadan, BS

[email protected]

717-531-6135

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