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AI and ultrasound join forces to crack the code of low back pain

NCT ID NCT06818175

Knowledge-focused Sponsor: Edward Via Virginia College of Osteopathic Medicine 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study uses ultrasound imaging and machine learning to better understand low back pain by looking at the thoracolumbar fascia, a layer of tissue in the back. Researchers will compare images from people with acute pain, chronic pain, and no pain. Some participants with chronic pain will receive either a fluid injection (hydrodissection) or osteopathic manipulative treatment to see if these help. The goal is to develop better ways to diagnose and treat low back pain.

What this could mean

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

Active substance
Hydrodissection (fluid injection) and Osteopathic Manipulative Treatment (OMT)
What this could lead to
If successful, this could lead to better diagnosis and new treatment options for chronic low back pain using ultrasound and machine learning.
What could go wrong
This is an early pilot study with small groups and no control for the treatment arms. The machine learning tools are still being developed, so results may not be conclusive.

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 200 people

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

Started

Sep 2023

Expected to finish

Dec 2026

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

18 to 50 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * ALL 18-50 year olds with No Low Back Pain (LBP); Acute LBP (\< 3 months); or Chronic LBP (\> 3 months) Exclusion Criteria: * Allergy to ultrasound gel - relative, consider alternatives * BMI: \> 30 * Pregnancy or Breastfeeding: current or remote, within the past 6 months * Spinal Surgery: history of lower thoracic or lumbar spine: within the past year, of more than a single level of hardware. (prior single level microdiscectomy, laminectomy, or fusion, that is stable for 1 year or greater is NOT excluded) * Current Low Back Pain (LBP) or Injury: severe enough to 1) limits activities of daily living, 2) limits the ability to work to less than an 8-hour day, 3) unable to lie prone with a pillow under their abdomen/pelvis for 30-45 minute intervals * History of Spinal Pathology: ankylosing spondylitis, rheumatoid arthritis or other rheumatic diseases, spinal tumor, or spinal infection * Corticosteroids: Injections into the low back or systemic medication within the last 3 months. Must be able to cease injections and/or corticosteroid medication during the study * Medication Usage that cannot be discontinued for length study: anticoagulants, muscle relaxants * Physical or Manual Therapy Interventions: in the last 90 days: physical therapy, acupuncture or trigger point therapy, any type of manual medicine or other bodywork treatments

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Conditions

The condition(s) this trial relates to.

Low Back Pain myofascial pain syndrome

As listed by the trial registrant

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

Acute low back pain Chronic low back pain Low back pain

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • Edward Via College of Osteopathic Medicine

    RECRUITING

    Blacksburg, Virginia, 24060, United States

    Contact Email: •••••@•••••

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