Back Pain Without RadiationNCT03912519
Parallel Versus Perpendicular Technique for Lumbar Medial Branch Radiofrequency Neurotomy
A study testing Parallel placement of 16 gauge electrodes and Perpendicular placement with 22 gauge electrodes in people with Back Pain Without Radiation and Low Back Pain, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Low back pain is a leading cause of disability worldwide. The lumbar zygapophyseal joints (z-joints) are estimated to be the source of low back pain between 10% and 40% of the time. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Back Pain Without Radiation, Low Back Pain, Lumbar Radiofrequency Neurotomy
- What is being tested?
- Parallel placement of 16 gauge electrodes and Perpendicular placement with 22 gauge electrodes
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2019to 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged > 40, capable of understanding and providing consent in English, capable of complying with the outcome instruments used, capable of attending all planned follow up visits
- unilateral or bilateral low back pain of at least 4/10 on Numeric Pain Rating Scale (NPRS) present for at least 2 months that has failed to adequately respond to at least 6 weeks of physical therapy and oral pain medication
- at least 80% improvement on two consecutive lumbar medial branch blocks of no more than a total of 4 lumbar facet joints
- beyond the above stated criteria, the decision to initiate the process of a first medial branch block is based on clinical decision making of the treating physician
- Patient consents to treatment in a shared decision-making process with the treating physician.
Who cannot join
- Those whose primary complain is lumbar radiculopathy
- Those receiving remuneration for their pain treatment (e.g., disability, worker's compensation).
- Those involved in active litigation relevant to their pain.
- Those unable to read English and complete the assessment instruments.
- Those unable to attend follow up appointments
- The patient is incarcerated.
Show all 17Show fewer
- History of prior lumbar fusion
- Progressive motor deficit, and/or clinical signs of cauda equina or polyradiculopathy
- History of lumbar steroid injection (epidural steroid injection, sacroiliac joint steroid injection, lumbar facet steroid injection) within the prior 3 months.
- Possible pregnancy or other reason that precludes the use of fluoroscopy.
- Allergy to contrast media or local anesthetics.
- BMI>40.
- Active Systemic inflammatory arthritis (e.g., rheumatoid arthritis, ankylosing spondylitis, lupus).
- Active infection or treatment of infection with antibiotics within the past 7 days.
- Medical conditions causing significant functional disability (e.g., stroke, COPD)
- Chronic widespread pain or somatoform disorder (e.g. fibromyalgia).
- Addictive behavior, severe clinical depression, or psychotic features.
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
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
Official title: Randomized Trial Comparing Parallel Versus Perpendicular Technique for Lumbar Medial Branch Radiofrequency Neurotomy
Low back pain is a leading cause of disability worldwide. The lumbar zygapophyseal joints (z-joints) are estimated to be the source of low back pain between 10% and 40% of the time. Observational studies have shown that lumbar medial branch radiofrequency neurotomy (LMBRFN) can be an effective treatment for z-joint low back pain. Nonetheless, other publications such as the Cochrane collaboration systematic review and the "Minimal Interventional Treatments for Participants with Chronic Low Back Pain" or "MINT" randomized controlled trial conclude that LMBRFN is not efficacious. These discrepancies in the literature may be due to differences in patient selection and procedural technique. This study aims to employ patient selection via dual medial branch block resulting in at least 80% relief on both occasions. Using this rather strict enrollment criteria, the aim of the study is to then compare LMBRFN utilizing 16 gauge needles via the "parallel" approach as endorsed by Spine Intervention Society guidelines to LMBRFN performed with 22 gauge needles and another commonly employed "perpendicular" technique similar to that approach used for medial branch blocks. The primary outcome of the study will be to determine if there is a difference in the percentage of patients with lumbar facet pain who achieve moderate or good response (improvement of Numeric Pain Rating Scale of at least 50% or 80%) or in the duration of effect (median duration of moderate or good response in those with positive outcome) between these two groups.
- Being tested
- Parallel placement of 16 gauge electrodes, Perpendicular placement with 22 gauge electrodes
- Medical subject headings
- Back Pain, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parallel placement of 16 gauge electrodesProcedure or surgery
Parallel technique
Perpendicular placement with 22 gauge electrodesProcedure or surgery
Perpendicular technique
| Study group | Role | What they receive |
|---|---|---|
| Parallel placement of 16 gauge electrodes | Active comparator | Parallel Group will undergo radiofrequency ablation via the approach described in Spine Intervention Practice Guidelines via 16 gauge electrodes. Specifically, the target nerve will be targeted with a parallel approach so as the electrode lay parallel to the nerves location within the sulcus formed by the neck of superior articular process and transverse process (or sacral ala for L5) cephalad to the point it is covered by the mamillo-accessory ligament. Receives: Procedure: Parallel placement of 16 gauge electrodes |
| Perpendicular placement with 22 gauge electrodes | Active comparator | Perpendicular Group will undergo radiofrequency ablation via the approach described in Spine Intervention Society Practice Guidelines for medial branch blocks, using a 22 gauge electrode. Specifically, the target nerve will be targeted with a perpendicular approach so as the tip of electrode contact the nerve at some point of it course along the sulcus formed by the neck of superior articular process and transverse process (or sacral ala for L5) cephalad to the point it is covered by the mamillo-accessory ligament. Receives: Procedure: Perpendicular placement with 22 gauge electrodes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), Global Impression of Change
Global Impression of Change; Range 0-7 0 = Very much improved 7 = Very much worse
Measured: Baseline to 12 months
Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), Numeric Rating Scale of Pain Intensity
Numeric Rating Scale of Pain Intensity; Range 0-10 0 = No pain 10 = Pain as bad as you can imagine
Measured: Baseline to 12 months
Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), Pain
Pain sub-scale as part of the Pain, Enjoyment, General Activity domain of COMBI; Range 0-10 0 = No Pain 10 = Pain as bad as you can image
Measured: Baseline to 12 months
Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), Enjoyment
Enjoyment sub-scale as part of the Pain, Enjoyment, General Activity domain of COMBI; Range 0-10 0 = Does not interfere 10 = Completely interferes
Measured: Baseline to 12 months
Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), General Activity
General Activity sub-scale as part of the Pain, Enjoyment, General Activity domain of COMBI; Range 0-10 0 = Does not interfere 10 = Completely interferes
Measured: Baseline to 12 months
Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), Number of Participants Not Requiring Other Healthcare
Categorical Outcome; ideal would be that patients no longer require other care for the condition for which they were treated. So, the scoring is simply absolute. The instrument is neither designed nor intended for more granular analysis, on the grounds that partial reduction in doses required, but nevertheless continuation of other treatment, falls short of indicating a worthwhile, successful outcome (PubMed Identifier: 25312899).
Measured: Baseline to 12 months
Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), Number of Participants Returning to Work
Categorical outcome; it is very relevant if return to work is achieved. Failure to return to work is too vexatious an issue, with so many determinants that it is neither efficient nor effective to bother trying to record them (Reference PMID: 25312899).
Measured: Baseline to 12 months
Change in Oswestry Disability Index (ODI)
The questionnaire is designed to give information on how pain is affecting the ability to manage everyday life. The range of scores is 0-100%.
0-20%: "minimal disability": The patient can cope with most living activities. Usually no treatment is indicated apart from advice on lifting sitting and exercise.
21-40%: "moderate disability": The patient experiences more pain and difficulty with sitting, lifting and standing. Travel and social life are more difficult and they may be disabled from work. Personal care, sexual activity and sleeping are not grossly affected and the patient can usually be managed by conservative means.
41-60%: "severe disability": Pain remains the main problem in this group but activities of daily living are affected.
61-80%: "crippled": Back pain impinges on all aspects of the patient's life. 81-100%: These patients are either bed-bound or exaggerating their symptoms.
Measured: Baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start21 Aug 2019
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back Pain Without RadiationStudies of the same condition, open and under way.
- More trials run by Vanderbilt University 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Spine Intervention Society
- Responsible party
- Principal investigator, Byron Schneider, Vanderbilt University Medical Center
- Investigators
- Byron Schneider, MD, Principal investigator, Vanderbilt University Medical CenterBlake Fechtel, MD MSc, Study director, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03912519
- Sponsor's protocol ID
- 190556
- Status last verified
- Jul 2026
- First submitted
- 19 Mar 2019
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Comparing Parallel Versus Perpendicular Technique for Lumbar Medial Branch Radiofrequency Neurotomy
- ClinicalTrials.gov ID
- NCT03912519
- Acronym / sponsor ID
- 190556
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Spine Intervention Society
- Study start
- 21 Aug 2019 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 11 Apr 2019 (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.
Low back pain is a leading cause of disability worldwide. The lumbar zygapophyseal joints (z-joints) are estimated to be the source of low back pain between 10% and 40% of the time. Observational studies have shown that lumbar medial branch radiofrequency neurotomy (LMBRFN) can be an effective treatment for z-joint low back pain. Nonetheless, other publications such as the Cochrane collaboration systematic review and the "Minimal Interventional Treatments for Participants with Chronic Low Back Pain" or "MINT" randomized controlled trial conclude that LMBRFN is not efficacious. These discrepancies in the literature may be due to differences in patient selection and procedural technique. This study aims to employ patient selection via dual medial branch block resulting in at least 80% relief on both occasions. Using this rather strict enrollment criteria, the aim of the study is to then compare LMBRFN utilizing 16 gauge needles via the "parallel" approach as endorsed by Spine Intervention Society guidelines to LMBRFN performed with 22 gauge needles and another commonly employed "perpendicular" technique similar to that approach used for medial branch blocks. The primary outcome of the study will be to determine if there is a difference in the percentage of patients with lumbar facet pain who achieve moderate or good response (improvement of Numeric Pain Rating Scale of at least 50% or 80%) or in the duration of effect (median duration of moderate or good response in those with positive outcome) between these two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parallel placement of 16 gauge electrodes | Active comparator | Procedure: Parallel placement of 16 gauge electrodesParallel Group will undergo radiofrequency ablation via the approach described in Spine Intervention Practice Guidelines via 16 gauge electrodes. Specifically, the target nerve will be targeted with a parallel approach so as the electrode lay parallel to the nerves location within the sulcus formed by the neck of superior articular process and transverse process (or sacral ala for L5) cephalad to the point it is covered by the mamillo-accessory ligament. |
| Perpendicular placement with 22 gauge electrodes | Active comparator | Procedure: Perpendicular placement with 22 gauge electrodesPerpendicular Group will undergo radiofrequency ablation via the approach described in Spine Intervention Society Practice Guidelines for medial branch blocks, using a 22 gauge electrode. Specifically, the target nerve will be targeted with a perpendicular approach so as the tip of electrode contact the nerve at some point of it course along the sulcus formed by the neck of superior articular process and transverse process (or sacral ala for L5) cephalad to the point it is covered by the mamillo-accessory ligament. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- aged > 40, capable of understanding and providing consent in English, capable of complying with the outcome instruments used, capable of attending all planned follow up visits
- unilateral or bilateral low back pain of at least 4/10 on Numeric Pain Rating Scale (NPRS) present for at least 2 months that has failed to adequately respond to at least 6 weeks of physical therapy and oral pain medication
- at least 80% improvement on two consecutive lumbar medial branch blocks of no more than a total of 4 lumbar facet joints
- beyond the above stated criteria, the decision to initiate the process of a first medial branch block is based on clinical decision making of the treating physician
- Patient consents to treatment in a shared decision-making process with the treating physician.
Key exclusion criteria (17 listed)
- Those whose primary complain is lumbar radiculopathy
- Those receiving remuneration for their pain treatment (e.g., disability, worker's compensation).
- Those involved in active litigation relevant to their pain.
- Those unable to read English and complete the assessment instruments.
- Those unable to attend follow up appointments
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 |
|---|---|---|
| Parallel placement of 16 gauge electrodesParallel technique | Procedure or surgery | Parallel placement of 16 gauge electrodes |
| Perpendicular placement with 22 gauge electrodesPerpendicular technique | Procedure or surgery | Perpendicular placement with 22 gauge electrodes |
Primary outcome
Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), Global Impression of Change
Time frame: Baseline to 12 months
Global Impression of Change; Range 0-7 0 = Very much improved 7 = Very much worse
Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), Numeric Rating Scale of Pain Intensity
Time frame: Baseline to 12 months
Numeric Rating Scale of Pain Intensity; Range 0-10 0 = No pain 10 = Pain as bad as you can imagine
Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), Pain
Time frame: Baseline to 12 months
Pain sub-scale as part of the Pain, Enjoyment, General Activity domain of COMBI; Range 0-10 0 = No Pain 10 = Pain as bad as you can image
Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), Enjoyment
Time frame: Baseline to 12 months
Enjoyment sub-scale as part of the Pain, Enjoyment, General Activity domain of COMBI; Range 0-10 0 = Does not interfere 10 = Completely interferes
Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), General Activity
Time frame: Baseline to 12 months
General Activity sub-scale as part of the Pain, Enjoyment, General Activity domain of COMBI; Range 0-10 0 = Does not interfere 10 = Completely interferes
Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), Number of Participants Not Requiring Other Healthcare
Time frame: Baseline to 12 months
Categorical Outcome; ideal would be that patients no longer require other care for the condition for which they were treated. So, the scoring is simply absolute. The instrument is neither designed nor intended for more granular analysis, on the grounds that partial reduction in doses required, but nevertheless continuation of other treatment, falls short of indicating a worthwhile, successful outcome (PubMed Identifier: 25312899).
Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), Number of Participants Returning to Work
Time frame: Baseline to 12 months
Categorical outcome; it is very relevant if return to work is achieved. Failure to return to work is too vexatious an issue, with so many determinants that it is neither efficient nor effective to bother trying to record them (Reference PMID: 25312899).
Change in Oswestry Disability Index (ODI)
Time frame: Baseline to 12 months
The questionnaire is designed to give information on how pain is affecting the ability to manage everyday life. The range of scores is 0-100%. 0-20%: "minimal disability": The patient can cope with most living activities. Usually no treatment is indicated apart from advice on lifting sitting and exercise. 21-40%: "moderate disability": The patient experiences more pain and difficulty with sitting, lifting and standing. Travel and social life are more difficult and they may be disabled from work. Personal care, sexual activity and sleeping are not grossly affected and the patient can usually be managed by conservative means. 41-60%: "severe disability": Pain remains the main problem in this group but activities of daily living are affected. 61-80%: "crippled": Back pain impinges on all aspects of the patient's life. 81-100%: These patients are either bed-bound or exaggerating their symptoms.
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 13 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Back Pain Without Radiation
RecruitingPhase 4
Ibuprofen With or Without Dexamethasone for Acute Radicular Low Back Pain.
Radiculopathy, Lumbosacral Region, Back Pain With Radiation
Recruiting
AuriculoTherapy NeuroImaging
Low Back Pain, Chronic Low-back Pain
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.
Byron Schneider, MD principal investigator
Vanderbilt University Medical Center
Blake Fechtel, MD MSc study director
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parallel placement of 16 gauge electrodes and Perpendicular placement with 22 gauge electrodes in people with Back Pain Without Radiation and Low Back Pain, run by Vanderbilt University 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 5 inclusion and 17 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: enrolling by invitation, as of the sponsor's last update on 13 Jul 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Modified Clinical Outcome Measurement Brief Instrument (COMBI), Global Impression of Change (time frame: Baseline to 12 months). The study lists 8 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 13 Jul 2026.