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

Launched by EDWARD VIA VIRGINIA COLLEGE OF OSTEOPATHIC MEDICINE · Feb 4, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating the role of a specific tissue in the lower back called the thoracolumbar fascia (TLF) in people experiencing low back pain. Researchers want to understand how this tissue behaves in individuals with acute (short-term) and chronic (long-term) low back pain compared to those without pain. They aim to develop new imaging techniques to better identify issues in the TLF and assess two potential treatments: hydrodissection (a procedure using ultrasound to separate tissue layers) and osteopathic manipulative therapy (a hands-on approach to improve movement and relieve pain).

To participate, individuals aged 18-50 can include those with no back pain, those with acute pain (lasting less than three months), or chronic pain (lasting over three months). However, some people may not be eligible, such as those with certain medical conditions or recent back surgeries. Participants can expect to undergo physical exams, surveys, and ultrasound imaging, and if they qualify, they may receive one of the two treatments. After treatment, they will have follow-up assessments to see how well the treatment worked. This study aims to gather valuable information that could help improve future treatments for low back pain.

Gender

ALL

Eligibility 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