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NCT Number: NCT06283628

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Penn State Hershey College of Medicine

Hershey, Pennsylvania, 17033, United States

Location contact

Nancy Ruth Jarbadan, BS

CONTACT

[email protected]

717-531-6135

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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 -

Treatment and study plan

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.

Primary outcomes

  1. The number of patients whose procedure was successful (gained 50% or more reduction in numeric rating pain (NRS) scores).

    Time frame: Baseline

    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.

  2. The number of patients whose procedure was successful (gained 50% or more reduction in numeric rating pain (NRS) scores).

    Time frame: 1 month post-procedure.

    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.

  3. The number of patients whose procedure was successful (gained 50% or more reduction in numeric rating pain (NRS) scores).

    Time frame: 6 months post-procedure.

    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.

Secondary outcomes

  1. Oswestry Disability index (ODI)

    Time frame: Baseline

    10 questions assessing the functional impairment by the pain, using a 50 point scale, with 0 meaning no disability, and 50 meaning complete disability.

  2. Oswestry Disability index (ODI)

    Time frame: 1 month post-procedure.

    10 questions assessing the functional impairment by the pain, using a 50 point scale, with 0 meaning no disability, and 50 meaning complete disability.

  3. Oswestry Disability index (ODI)

    Time frame: 6 months post-procedure.

    10 questions assessing the functional impairment by the pain, using a 50 point scale, with 0 meaning no disability, and 50 meaning complete disability.

Other outcomes

  1. Number of subjects who ceased requiring analgesia

    Time frame: Baseline

    The patients will self-report their analgesic consumption.

  2. Number of subjects who ceased requiring analgesia

    Time frame: 1 month post-procedure

    The patients will self-report their analgesic consumption.

  3. Number of subjects who ceased requiring analgesia

    Time frame: 6 months post-procedure

    The patients will self-report their analgesic consumption.

Study contacts

Contact information is provided by the study sponsor or research team.

Nancy Ruth Jarbadan, BS

CONTACT

[email protected]

717-531-6135

Sponsors and collaborators

Lead sponsor

Milton S. Hershey Medical Center

Other

Registry information

Acronym: LMB-RFA

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 28, 2024
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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