RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 standard surveys, physical exam, functional tests, and ultrasound imaging to obtain both static images of the TLF at multiple transition zones. It further uses ultrasound to evaluate the dynamic gliding motion, via cine loops, of this fascia in 2 different body movements in subjects with acute low back pain (ALBP), with chronic low back pain (CLBP), and without low back pain (WLBP). All images will be clinically analyzed and further assessed by textural and machine learning analysis. Patients with CLBP (only) will choose to enter one of the two studies (DoD vs AOA) at the time of consent. All images will be clinically analyzed and further assessed by textural and machine learning analysis. Patients with CLBP (only) that are found to have TLF glide impairment or positive physical exam maneuvers suggesting TLF as etiology will enter the treatment arm of the chosen study at the time of consent, either ultrasound guided hydrodissection (USGH), or Osteopathic Manipulative Therapy (OMT). After receiving 3 treatments utilizing one of these modalities, the CLBP participants will have repeat standard surveys, physical exam, functional tests, and ultrasound imaging assessments at 2,4,6,12, and 24 weeks post-treatment. At the conclusion of this project, the investigators expect to have developed, refined, and implemented robust and feasible experimental and computational approaches which can be further expanded in larger-scale studies. The development of our data-driven computer models for the objective analysis of sonographic images of the TLF has high potential impact as it seeks to transform the assessment of TLF integrity, injury and healing via establishment of reliable US imaging biomarkers. The investigators anticipate that the tools developed will have broad utility to assess a variety of clinical treatments for the TLF. The investigators also hope to validate physical exam maneuvers that may predict TLF mediated LBP and have preliminary evidence of the efficacy of hydrodissection and OMT in TLF mediated LBP. In pursuit of these objectives, the investigators will adopt an innovative approach featuring a robust integration of clinical imaging, physical exam, pain and functional outcomes, quantitative image analysis, and machine learning analyses. Specific Aim 1: Compare sonographic TLF imaging characteristics in individuals with acute versus chronic pain to those without low back pain. Specific Aim 2: Develop a machine learning (ML) classification algorithm to reliably distinguish abnormal myofascial tissue in acute versus chronic pain stages from healthy tissue. Specific Aim 3: DoD Study: Assess the preliminary therapeutic efficacy of hydrodissection as a novel treatment for TLF pain using quantitative US imaging and ML tools. AOA Study: Assess the preliminary therapeutic efficacy of OMT as a treatment for CLBP using quantitative US imaging and ML tools.

Official Title

Machine Learning Analysis of Ultrasound Images for the Investigation of Thoracolumbar Myofascial Pain and Therapeutic Efficacy of Hydrodissection (DoD) and Osteopathic Manipulative Treatment (AOA) for Thoracolumbar Fascia Glide Impairment

Quick Facts

Study Start:2023-09-01
Study Completion:2026-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06818175

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * ALL 18-50 year olds with No Low Back Pain (LBP); Acute LBP (\< 3 months); or Chronic LBP (\> 3 months)
  1. * Allergy to ultrasound gel - relative, consider alternatives
  2. * BMI: \> 30
  3. * Pregnancy or Breastfeeding: current or remote, within the past 6 months
  4. * 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)
  5. * 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
  6. * History of Spinal Pathology: ankylosing spondylitis, rheumatoid arthritis or other rheumatic diseases, spinal tumor, or spinal infection
  7. * 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
  8. * Medication Usage that cannot be discontinued for length study: anticoagulants, muscle relaxants
  9. * 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

Contacts and Locations

Study Contact

Albert J Kozar, DO, FAOASM, R-MSK, =
CONTACT
540-232-8405
TLFstudy@gmail.com
Nicole Fremarek, DO
CONTACT
540-232-8405
TLFstudy@gmail.com

Principal Investigator

Gunnar Brolinson DO, FAOASM
STUDY_CHAIR
Edward Via Colege of Osteopathic Medicine
Albert J Kozar DO, FAOASM, R-MSK
PRINCIPAL_INVESTIGATOR
Edward Via College of Osteopathic Medicine

Study Locations (Sites)

Edward Via College of Osteopathic Medicine
Blacksburg, Virginia, 24060
United States

Collaborators and Investigators

Sponsor: Edward Via Virginia College of Osteopathic Medicine

  • Gunnar Brolinson DO, FAOASM, STUDY_CHAIR, Edward Via Colege of Osteopathic Medicine
  • Albert J Kozar DO, FAOASM, R-MSK, PRINCIPAL_INVESTIGATOR, Edward Via College of Osteopathic Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-01
Study Completion Date2026-03-31

Study Record Updates

Study Start Date2023-09-01
Study Completion Date2026-03-31

Terms related to this study

Keywords Provided by Researchers

  • Diagnostic Ultrasound
  • Machine Learning
  • Shear Wave Elastography
  • Osteopathic Manipulative Treatment (OMT)
  • Hydrodissection
  • Physical Exam
  • Fascia
  • Thoracolumbar Fascia

Additional Relevant MeSH Terms

  • Low Back Pain
  • Chronic Low-back Pain
  • Acute Low Back Pain