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NCT06818175 · ClinicalTrials.gov registry record · NA

Physical Exam, Static & Dynamic Ultrasound Assessment, & Treatment of Thoracolumbar Fascia (TLF) Mediated Low Back Pain

A NA study of Low Back Pain and Chronic Low Back Pain, sponsored by Edward Via Virginia College of Osteopathic Medicine.

Recruiting
Registry status
NA
Development phase
200
Enrollment target
1
Study location

NCT06818175 is a NA study of Low Back Pain and Chronic Low Back Pain that is actively recruiting participants, run by Edward Via Virginia College of Osteopathic Medicine. The registered enrollment target is 200 participants, below the 502-participant average among 122 other Low Back Pain trials with a reported enrollment target (60% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06818175, a NA study of Low Back Pain and Chronic Low Back Pain, is actively recruiting participants, sponsored by Edward Via Virginia College of Osteopathic Medicine.

RECRUITING
Registry status
NA
Development phase
200 participants
Enrollment target
1
Study location

Study Summary

This Study is for our continued study of the Thoracolumbar Fascia (TFL) in patients with and without low back pain by our experienced multidisciplinary team: Vincent Wang PhD, VT Biomedical Engineering \& Mechanics (BEAM). Albert J Kozar DO, FAOASM, R-MSK. P. Gunnar Brolinson, DO, FAOASM, FAOCFP. David T. Redden PhD, VCOM Research Biostatistician. Matthew Chung DO, VCOM and Team Physician at Virginia Tech. Edward Magalhaes, PhD, LPC, Psychiatry and Neuro- Behavioral Sciences, VCOM. This listing is specifically for our renewed efforts via two, Department of Defense (DoD) and American Osteopathic Association (AOA), extramurally, simultaneously funded grants for similar but distinct projects. Both funding sources are aware of each other's funding and have approved their grant study moving forward simultaneously with some integration. DoD: Machine Learning Analysis of Ultrasound Images for the Investigation of Thoracolumbar Myofascial Pain and Therapeutic Efficacy of Hydrodissection. The primary objectives of the proposed project are to: 1. develop reliable, quantitative image analysis approaches to objectively distinguish images from subjects with acute or chronic TLF pain from those without pain and 2. to assess the preliminary clinical efficacy of hydrodissection of the TLF as a novel therapeutic treatment for chronic LBP. AOA: Assessment of the Therapeutic Efficacy of OMT on Chronic Low Back Pain: An Integrated Sonographic and Machine Learning Analysis of Thoracolumbar Fascia Glide Impairment. The primary objectives of the proposed project are to: 1. assess the preliminary clinical efficacy of OMT as a therapeutic treatment for CLBP of TLF origin and 2. develop reliable, quantitative image analysis approaches to objectively distinguish images from subjects with TLF pain from those without pain. These projects will share 50 no LBP subjects as controls. The DOD study will include 50 acute LBP and 50 CLBP. The AOA study will include 50 CLBP. This project uses

Interventions

  • PROCEDURE Osteopathic Manipulative Treatment (OMT)
  • PROCEDURE Ultrsound Guided Hydrodissection of the Thoracolumbar Fascia

Study Locations (1)

Virginia

  • Edward Via College of Osteopathic Medicine - Blacksburg

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2023-09-01
Est. Completion 2026-12-31
Phase NA

What the Registry Record Tells You About NCT06818175

The ClinicalTrials.gov registry entry for NCT06818175 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 502-participant average among 122 other Low Back Pain trials with a reported enrollment target (60% lower). The listed sponsor is Edward Via Virginia College of Osteopathic Medicine, which has 19 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Low Back Pain appearing as the primary indexed condition, and to 2 interventions - of which Osteopathic Manipulative Treatment (OMT) is the first listed.

NCT06818175 reports 1 study location spanning 1 distinct geographic area - top geographies include Virginia.

Frequently Asked Questions

What is clinical trial NCT06818175 about?

NCT06818175 is a clinical study titled "Physical Exam, Static & Dynamic Ultrasound Assessment, & Treatment of Thoracolumbar Fascia (TLF) Mediated Low Back Pain". This Study is for our continued study of the Thoracolumbar Fascia (TFL) in patients with and without low back pain by our experienced multidisciplinary team: Vincent Wang PhD, VT Biomedical Engineering \& Mechanics (BEAM). Albert J Kozar DO, FAOASM, R-MSK. P. Gunnar Brolinson, DO, FAOASM, FAOCFP. D...

What is the current status of trial NCT06818175?

This trial is currently recruiting. It is a NA study. The enrollment target is 200 participants. The study started on 2023-09-01. Estimated completion is 2026-12-31.

What conditions does trial NCT06818175 study?

This clinical trial studies the following conditions: Low Back Pain, Chronic Low Back Pain, Acute Low Back Pain.

What interventions are being tested in trial NCT06818175?

The interventions under investigation include: Osteopathic Manipulative Treatment (OMT) (PROCEDURE), Ultrsound Guided Hydrodissection of the Thoracolumbar Fascia (PROCEDURE).

Who is sponsoring clinical trial NCT06818175?

This trial is sponsored by Edward Via Virginia College of Osteopathic Medicine, which has 19 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06818175 being conducted?

This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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