Lumbar SpondylosisLMB-RFANCT06283628
Comparative Effectiveness of Two Different Approaches to Radiofrequency Ablation of Lumbar Medial Branch Nerves
A study testing Radiofrequency ablation of lumbar medial branch nerves. in people with Lumbar Spondylosis, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Spondylosis
- What is being tested?
- Radiofrequency ablation of lumbar medial branch nerves.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2027to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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 -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Penn State Hershey College of Medicine
Hershey, Pennsylvania, 17033
Nancy Ruth Jarbadan, BS, 717-531-6135, njarbadan@pennstatehealth.psu.edu
About this study
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.
Read the 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.
- Conditions
- Lumbar Spondylosis
- Being tested
- Radiofrequency ablation of lumbar medial branch nerves.
- Medical subject headings
- Spondylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency ablation of lumbar medial branch nerves.Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Radiofrequency ablation of lumbar medial branch nerves. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 months post-procedure.
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 6 months post-procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study startAug 2027 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar SpondylosisStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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,
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bunty Shah, Milton S. Hershey Medical Center
- Investigators
- Yakov Vorobeychik, MD PhD, Principal investigator, Professor, Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06283628
- Sponsor's protocol ID
- STUDY00023737
- Acronym
- LMB-RFA
- Status last verified
- Oct 2025
- First submitted
- 21 Feb 2024
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD data that underlie the results reported in this article, after deidentification (text, tables, figures)
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Two Different Approaches to Radiofrequency Ablation of Lumbar Medial Branch Nerves
- ClinicalTrials.gov ID
- NCT06283628
- Acronym / sponsor ID
- LMB-RFA / STUDY00023737
- Conditions
- Lumbar Spondylosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Aug 2027 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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,
| Arm | Type | Receives |
|---|---|---|
| Subjects with traditional approach on the right side and parasagittal approach on the left side. | Active comparator | Procedure: Radiofrequency ablation of lumbar medial branch nerves.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. |
| Subjects with traditional approach on the left side and parasagittal approach on the right side. | Active comparator | Procedure: Radiofrequency ablation of lumbar medial branch nerves.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- Radicular pain below the knee
- Systemic infection or localized infection at the anticipated introducer entry site
- Pregnancy
- Allergy to Lidocaine
- Bleeding dyscrasias
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | 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. |
Primary outcome
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.
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.
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.
3 secondary outcomes
Oswestry Disability index (ODI)
Time frame: Baseline
Oswestry Disability index (ODI)
Time frame: 1 month post-procedure.
Oswestry Disability index (ODI)
Time frame: 6 months post-procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: Yes. IPD data that underlie the results reported in this article, after deidentification (text, tables, figures)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yakov Vorobeychik, MD PhD principal investigator
Professor, Department of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency ablation of lumbar medial branch nerves. in people with Lumbar Spondylosis, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nancy Ruth Jarbadan, BS (717-531-6135, njarbadan@pennstatehealth.psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients whose procedure was successful (gained 50% or more reduction in numeric rating pain (NRS) scores). (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.