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

NCT06818175 | Recruiting

• 1 other identifier: 2023-154
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.to assess the preliminary clinical efficacy of hydrodissection of the TLF as a novel therapeutic treatment for chronic LBP.
3. 3.assess the preliminary clinical efficacy of OMT as a therapeutic treatment for CLBP of TLF origin and
4. 4.develop reliable, quantitative image analysis approaches to objectively distinguish images from subjects with TLF pain from those without pain.

Conditions

Low Back Pain; Chronic Low-back Pain; Acute Low Back Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Passive and Active motion induced TLF glide motion

  Glide motion will be measured in mm. As Pilot Study, the lower 33rd percentile of motion will be considered glide impairment. Dynamic cine loops are obtained with 1. Five cycles of 20 degree prone trunk flexion (PTF) induced by a motorized table were recorded, with probe centered vertically over L3-L4 paraspinal muscles. 2. Five cycles of 12" prone active straight leg raise (pASLR), contralateral \& ipsilateral, were recorded with probe centered vertically over T12-L1 paraspinal muscles. Active glide has never been studied. the investigators will be looking at multiple properties of glide motion. In regards to AIM 3 treatment arms, after all 3 treatments of either hydrodisection or OMT, are completed: 1. Short term improvement will be assessed compared to baseline at 6 weeks. 2. Long Term improvement will be assessed compared to baseline at 24 weeks.

  After AIM 3 treatment arms, after all 3 treatments of either hydrodisection or OMT, are completed: 1) Short term improvement will be assessed compared to baseline at 6 weeks. 2) Long Term improvement will be assessed compared to baseline at 24 weeks

Secondary Outcomes (3)

• Physical Exam Maneuvers to Predict TLF involvement in Subjects with CLBP.

  Positive tests will be determined at baseline. Resolution of positive tests after CLBP subject treatments will be assessed at 2 week followup scans.

• SWE measurements in CLBP vs No LBP

  At Baseline.

• SWE measurements Post Treatments in CLBP Subjects

  After AIM 3 treatment arms, after all 3 treatments of either hydrodisection or OMT, are completed: 1) Short term improvement will be assessed compared to baseline at 6 weeks. 2) Long Term improvement will be assessed compared to baseline at 24 weeks

Study Arms (2)

Ultrasound Guided Hydrodissection of TLF Glide Impairment

EXPERIMENTAL

CLBP Subjects with documented TLF glide impairment will undergo a series of 3 ultrasound-guided hydrodissection treatments of the TLF at 2-3 locations bilaterally, covering T11-S2, using D5w (132 cc total) and 22g 4" needle at 2-3 week intervals, using direct ultrasound guidance using a high frequency probe. Fluid pressure dissection/debridement (a fluid wave) is utilized to create tissue plane separation as opposed to needle mechanical debridement.

Procedure: Ultrsound Guided Hydrodissection of the Thoracolumbar Fascia

Osteopathic Manipulative Treatment (OMT)

EXPERIMENTAL

CLBP Subjects with documented TLF glide impairment will undergo a screening structural examination for somatic dysfunction and then be treated by OMT as based on clinical experience using a principle based protocol. A series of 3 OMT treatment sessions spaced at 2-week intervals. The same procedures will be used in this study as we use in our daily clinical practice. This is a pilot treatment arm, no sham or direct blinding will be utilized. Subjects will be screening using the Area of Greatest Restriction (AGR) protocol as taught by Ed Stiles DO (Textbook of Osteopathic Medicine Ch. 24 by Stiles pp. 265-266). After treating 2-3 areas by this method, the examiner will also screen the Lumbar, Sacrum \& Pelvis by standard Osteopathic Structural Evaluation (standing \& supine/prone). An additional 1-2 areas may be treated. Treatments may include High Velocity, Low Amplitude (HVLA), Low Velocity, High Amplitude, soft tissue, myofascial release and muscle energy manipulation techniques.

Procedure: Osteopathic Manipulative Treatment (OMT)

Interventions

Ultrsound Guided Hydrodissection of the Thoracolumbar Fascia PROCEDURE

The injection of a fluid solution to separate facial or tissue layers in the body. Usually guided by ultrasound.

Ultrasound Guided Hydrodissection of TLF Glide Impairment

Osteopathic Manipulative Treatment (OMT) PROCEDURE

The therapeutic application of manually guided forces by an osteopathic physician (US Usage) to improve physiologic function and/or support homeostasis that has been altered by somatic dysfunction. OMT employs a variety of techniques.

Osteopathic Manipulative Treatment (OMT)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ALL 18-50 year olds with No Low Back Pain (LBP); Acute LBP (\< 3 months); or Chronic LBP (\> 3 months)

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: collaborator
• Edward Via Virginia College of Osteopathic Medicine: lead

Study Sites (1)

Edward Via College of Osteopathic Medicine

Blacksburg, Virginia, 24060, United States

RECRUITING

Related Publications (1)

• Langevin HM, Fox JR, Koptiuch C, Badger GJ, Greenan-Naumann AC, Bouffard NA, Konofagou EE, Lee WN, Triano JJ, Henry SM. Reduced thoracolumbar fascia shear strain in human chronic low back pain. BMC Musculoskelet Disord. 2011 Sep 19;12:203. doi: 10.1186/1471-2474-12-203.

  PMID: 21929806 BACKGROUND

Related Links

• Facebook Advertisement for Interested Subjects

MeSH Terms

Conditions

Low Back Pain

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Gunnar Brolinson DO, FAOASM

  Edward Via Colege of Osteopathic Medicine

  STUDY CHAIR

• Albert J Kozar DO, FAOASM, R-MSK

  Edward Via College of Osteopathic Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Albert J Kozar, DO, FAOASM, R-MSK, =

CONTACT

540-232-8405; TLFstudy@gmail.com

Nicole Fremarek, DO

CONTACT

540-232-8405; TLFstudy@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Osteopathic Manipulative Medicine (OMM), Department of Sports Medicine

Model Details: The investigators will treat CLBP subjects (identified from Aim 1 with TLF glide impairment) with hydrodissection and follow them longitudinally at baseline and five follow-up time points. A series of 3 ultrasound-guided hydrodissection treatments of the TLF at 2-3 locations bilaterally, covering T11-S2, at 2-3 week intervals, using D5W (132 cc total) AOA: Specific Aim 3: Assess the preliminary therapeutic efficacy of OMT as a treatment for CLBP using quantitative US imaging and ML tools. The investigators will treat CLBP subjects (identified from Aim 1 with TLF glide impairment) with OMT and follow them longitudinally at baseline and five follow-up time points. Subjects will undergo a screening structural examination for somatic dysfunction and then be treated by OMT using a principle based protocol (AGR).

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: February 10, 2025
• Study Start: September 1, 2023
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 13, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)