Which needle angle wins for back pain? trial tests two techniques Head-to-Head

NCT ID NCT03912519

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time

Summary

This trial compares two ways of performing a procedure called lumbar medial branch radiofrequency neurotomy for chronic low back pain. One method uses a parallel needle placement with larger electrodes, while the other uses a perpendicular placement with smaller needles. The goal is to see which technique provides better and longer-lasting pain relief in people whose pain comes from the facet joints in the lower back.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
radiofrequency neurotomy (nerve heating procedure)
What this could lead to
If one technique proves superior, it could lead to more effective and longer-lasting pain relief for people with chronic low back pain from facet joints.
What could go wrong
This is a small, early-stage comparison study. Even if one technique works better, results may not apply to all back pain patients, and some people may not respond at all.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 132 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2019

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.

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Conditions

The condition(s) this trial relates to.

Back Pain Low Back Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37212, United States

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