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OpenTrials
Completed

NCT Number: NCT04823637

Evaluating for a Correlation Between Osteopathic Examination and Ultrasonography on Thoracic Spine Asymmetry

Context: Thoracic spine is a common area of focus in osteopathic manipulative medicine (OMM) for a variety of conditions. Thoracic spine somatic dysfunction diagnosis is achieved by palpating for asymmetry at the tips of the transverse processes. Previous studies reveal that, instead of following the rule of threes, the transverse processes of a given thoracic vertebra generally align with the spinous process of the vertebra above. Ultrasonography has been widely used as a diagnostic tool to monitor musculoskeletal conditions. Ultrasound has the advantage of absence of radiation, and has shown comparable results to gold standard modalities like MRI in some areas of the spine. In the case of thoracic somatic dysfunction, ultrasound can be used to determine the location of each vertebral transverse process and its relationship with the spinous process. Previous studies have investigated the correlation between osteopathic manipulative medicine and ultrasonography of the cervical, lumbar, and sacral regions. However, no study has yet compared osteopathic structural examination with ultrasonographic examination of the thoracic vertebral region.

Objective: To determine whether there is a dependable correlation of osteopathic palpatory findings of the thoracic transverse processes with the measurements of ultrasonography.

Methods: Subjects were student volunteers recruited from the Midwestern University - Glendale campus. A non-toxic, non-permanent marker was used to mark bony landmarks on the skin to be used by the osteopathic examiners. Two osteopathic physicians (OMM1, OMM2) separately performed structural exams by palpating T2-T5 transverse processes to determine vertebral rotation. Two trained sonographers (US1, US2) separately scanned and measured the distance from the tip of the spinous process to the adjacent transverse processes of the vertebral segment below. Demographic variables were summarized with mean and standard deviation. Interexaminer reliability was assessed with percent agreement, Cohen's Kappa, and Fleiss' Kappa. Recruitment and protocols were approved by the MWU Institutional Review Board.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Midwestern University

Glendale, Arizona, 85308, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • First- and Second-year osteopathic medical students who received an email notification
  • Masters program students who received an email notification

Exclusion criteria

  • A history of or currently diagnosed with scoliosis, spondylosis, spondylolisthesis, herniated disc, spinal fracture, or surgery to the spine

Treatment and study plan

Ultrasonography vs Osteopathic manipulative medicine structural exam

Diagnostic Test

Structural examination of the thoracic spine using ultrasound and osteopathic palpatory examination on skin.

Primary outcomes

  1. Interexaminer reliability

    Time frame: Through study completion, which was an average of about 1 year

    We looked at the interexaminer reliability between ultrasound and osteopathic structural exam of the thoracic spine.

Sponsors and collaborators

Lead sponsor

Midwestern University

Other

Registry information

Acronym: USOMM

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Apr 1, 2021
Registry last updated
Apr 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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