Comparative Effectiveness of Two Different Approaches to Radiofrequency Ablation of Lumbar Medial Branch Nerves (LMB-RFA)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lumbar Spondylosis
• Intervention / Treatment: Procedure: Radiofrequency ablation of lumbar medial branch nerves.

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nancy Ruth Jarbadan, BS; Phone Number: 717-531-6135; Email: njarbadan@pennstatehealth.psu.edu

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Hershey College of Medicine
      • Contact: Nancy Ruth Jarbadan, BS; Phone Number: 717-531-6135; Email: njarbadan@pennstatehealth.psu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of patients whose procedure was successful (gained 50% or more reduction in numeric rating pain (NRS) scores).	The patients will describe the pain intensity using NRS - 11-point numeric rating scale, with 0 means no pain, and 10 - the worst possible pain intensity.	Baseline
The number of patients whose procedure was successful (gained 50% or more reduction in numeric rating pain (NRS) scores).	The patients will describe the pain intensity using NRS - 11-point numeric rating scale, with 0 means no pain, and 10 - the worst possible pain intensity.	1 month post-procedure.
The number of patients whose procedure was successful (gained 50% or more reduction in numeric rating pain (NRS) scores).	The patients will describe the pain intensity using NRS - 11-point numeric rating scale, with 0 means no pain, and 10 - the worst possible pain intensity.	6 months post-procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability index (ODI)	10 questions assessing the functional impairment by the pain, using a 50 point scale, with 0 meaning no disability, and 50 meaning complete disability.	Baseline
Oswestry Disability index (ODI)	10 questions assessing the functional impairment by the pain, using a 50 point scale, with 0 meaning no disability, and 50 meaning complete disability.	1 month post-procedure.
Oswestry Disability index (ODI)	10 questions assessing the functional impairment by the pain, using a 50 point scale, with 0 meaning no disability, and 50 meaning complete disability.	6 months post-procedure.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects who ceased requiring analgesia	The patients will self-report their analgesic consumption.	Baseline
Number of subjects who ceased requiring analgesia	The patients will self-report their analgesic consumption.	1 month post-procedure
Number of subjects who ceased requiring analgesia	The patients will self-report their analgesic consumption.	6 months post-procedure

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Investigators: Principal Investigator: Yakov Vorobeychik, MD PhD, Professor, Department of Anesthesiology

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Spondylosis
• Other Study ID Numbers: STUDY00023737

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD data that underlie the results reported in this article, after deidentification (text, tables, figures)
• IPD Sharing Time Frame: Beginning 1 month and ending 3 years following article publication.
• IPD Sharing Access Criteria: Researches who provide a methodologically sound proposal to achieve aims in the approved proposal. proposals should be directed to yvorobeychik@pennstatehealth.psu.edu.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No