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

NCT06283628 | Not Yet Recruiting

• 1 other identifier: STUDY00023737
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lumbar Spondylosis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Oswestry Disability index (ODI)

  Baseline

• Oswestry Disability index (ODI)

  1 month post-procedure.

• Oswestry Disability index (ODI)

  6 months post-procedure.

Other Outcomes (3)

• Number of subjects who ceased requiring analgesia

  Baseline

• Number of subjects who ceased requiring analgesia

  1 month post-procedure

• Number of subjects who ceased requiring analgesia

  6 months post-procedure

Study Arms (2)

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

ACTIVE COMPARATOR

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.

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

ACTIVE COMPARATOR

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.

Interventions

Radiofrequency ablation of lumbar medial branch nerves. PROCEDURE

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.

Subjects with traditional approach on the left side and parasagittal approach on the right side.; Subjects with traditional approach on the right side and parasagittal approach on the left side.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Hershey College of Medicine

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Spondylosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Yakov Vorobeychik, MD PhD

  Professor, Department of Anesthesiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nancy Ruth Jarbadan, BS

CONTACT

717-531-6135; njarbadan@pennstatehealth.psu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: We will do computer randomization for the sides for each approach for all the subjects. The subjects will be assigned numbers, and the particular procedural approach for each side will be concealed in the numbered envelopes. The numbers on the envelopes will correspond to the numbers assigned to the patients. The envelopes will be opened by a treating physician in the procedure room. The patient and the assessor (who will not be the treating physician) will not know which procedural approach was used for the sides.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Anesthesiology and Perioperative Medicine

Model Details: The subjects with bilateral low back pain will undergo radiofrequency ablation of the lumbar medial branch nerves using one approach (traditional) on one side and different approach (parasagittal) on the other side. One arm will use the traditional approach on the left and the parasagittal approach on the right. The other arm will use parasagittal approach on the left and the traditional approach on the right,

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: February 28, 2024
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: March 5, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 1 month and ending 3 years following article publication.
• 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.

Locations

US (1)