Assessment and treatment of low back pain using ultrasound and osteopathic techniques
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
This study is trying to see if using ultrasound and hands-on techniques can help people with low back pain by looking closely at a specific part of the back called the thoracolumbar fascia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Edward Via Virginia College of Osteopathic Medicine Academic / other |
| Locations | 1 site (Blacksburg, Virginia) |
| Trial ID | NCT06818175 on ClinicalTrials.gov |
What this trial studies
This study investigates the role of the thoracolumbar fascia in low back pain through advanced imaging techniques and treatment methods. It involves a multidisciplinary team that will analyze ultrasound images to identify biomarkers associated with low back pain and evaluate the effectiveness of ultrasound-guided hydrodissection and osteopathic manipulative treatment. The study will include both symptomatic and asymptomatic participants to establish a comprehensive understanding of the thoracolumbar fascia's involvement in pain conditions. The findings aim to enhance clinical decision-making for low back pain management.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18-50 with either acute or chronic low back pain, as well as those without any low back pain.
Not a fit: Patients with a history of significant spinal surgery, severe low back pain limiting daily activities, or certain spinal pathologies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and treatment options for patients suffering from low back pain.
How similar studies have performed: While this approach is innovative, similar studies utilizing ultrasound and machine learning for pain assessment have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Blacksburg, Virginia
- Edward Via College of Osteopathic Medicine — Blacksburg, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Albert J Kozar DO, FAOASM, R-MSK — Edward Via College of Osteopathic Medicine
- Study coordinator: Albert J Kozar, DO, FAOASM, R-MSK, =
- Email: TLFstudy@gmail.com
- Phone: 540-232-8405
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.