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Sound waves for back pain? new device tested in small trial

NCT ID NCT06611397

Symptom relief Sponsor: Columbia University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a device called Discogen that uses low-intensity ultrasound to treat pain from a herniated disc. About 40 adults with leg or back pain will receive either the real treatment or a sham (fake) treatment. The goal is to see if the device safely reduces pain and improves daily function.

What this could mean

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

Active substance
Low-intensity pulsed ultrasound (LIPUS) device
What this could lead to
If it works, this could offer a non-invasive, drug-free option to reduce pain from herniated discs.
What could go wrong
This is a very small early feasibility study with only 40 people. The device may not prove more effective than sham treatment, and results may not apply to everyone.

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 5 people

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

Started

Mar 2025

Expected to finish

Aug 2027

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

21 to 75 years

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 The subject may be included in the study if the following conditions are met: 1. Adult (\> 21 y.o.) males and females legally able and willing to participate and provide consent in the study and attend follow-up visits 2. Able and willing to complete study forms and communicate with the investigator 3. Presenting with unilateral radicular leg pain with or without axial back pain of \>1 month duration 4. No epidural injections at treatment site within the last three months 5. Leg NPS pain score of 4 - 9 in the last month (on a scale of 0 to 10) 6. Clinical presentation of sensory radiculopathy referable to single-level disc disease/herniation at L3-4, L4-5 or L5-S1 7. MRI lumbar spine negative for extruded disc herniation, tumor, or bleeding, but positive for disc disease/herniation at L3-4, L4-5 or L5-S1 with mild to moderate foraminal or spinal stenosis (less than 50%). Exclusion Criteria: 1. Pregnant or breastfeeding patient 2. Younger than 21 or older than 75 years 3. Presenting with motor deficits 4. Presenting with a baseline Oswestry Disability Index ≥ 41% (severe disability or worse) 5. Presence of metal hardware within the lumbosacral spine 6. History of spine surgery at the level of treatment. 7. Lumbar spine pathology that may increase procedural risk and/or influence symptoms and/or generate unrelated adverse events (per the discretion of the study PI) 8. Severe lumbar central canal stenosis (greater than 50%) 9. Severe lumbar foraminal stenosis (greater than 50%) 10. Severe herniated lumbar disc 4(Grade 2 and above) 11. Lumbar instability on flexion/extension plain films, greater the Grade 1 spondylolisthesis 12. Unable to understand and complete research questionnaires 13. Any severe medical condition preventing the patient from safely and effectively being treated in the study or reporting study outcomes. 14. BMI greater than 30 15. Implanted spinal stimulators 16. Epidural injections at treatment site within the last three months

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Conditions

The condition(s) this trial relates to.

Intervertebral Disc Displacement lumbar disk herniation, susceptibility to

As listed by the trial registrant

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

Disc herniation

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

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

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  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

  • Columbia University Irving Medical Center

    RECRUITING

    New York, New York, 10032, United States

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