Osteopathic Manipulative TreatmentUSOMMNCT04823637
Evaluating for a Correlation Between Osteopathic Examination and Ultrasonography on Thoracic Spine Asymmetry
An observational study of Osteopathic Manipulative Treatment and Ultrasonography, run by Midwestern University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteopathic Manipulative Treatment, Ultrasonography
- What is being tested?
- Ultrasonography vs Osteopathic manipulative medicine structural exam
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2019to 14 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects are Midwestern University students who were recruited via email announcements, with responses recorded via secure Google Form that was accessible only to the Midwestern University network. The overall demographics of participants showed 31 (47.0%) males and 35 (53.0%) females. Race and ethnicity were not collected for the purpose of this study as it was not a variable being evaluated or investigated. The subjects' age range is 22-35 years of age, with the mean age as 26.61 (SD = 3.1) for males and 25.71 (SD = 2.7) for females. The BMI range is 15.9 - 36.9kg/m2, with the mean BMI as 24.13 (SD = 4.2) overall, 25.46 (SD = 3.5) for males and 22.95 (SD = 4.5) for females.
Who may be able to join
- First- and Second-year osteopathic medical students who received an email notification
- Masters program students who received an email notification
Who cannot join
- A history of or currently diagnosed with scoliosis, spondylosis, spondylolisthesis, herniated disc, spinal fracture, or surgery to the spine
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Ultrasonography vs Osteopathic manipulative medicine structural exam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonography vs Osteopathic manipulative medicine structural examDiagnostic test
Structural examination of the thoracic spine using ultrasound and osteopathic palpatory examination on skin.
What is being measured
The primary outcome is the main question the study is designed to answer.
Interexaminer reliability
We looked at the interexaminer reliability between ultrasound and osteopathic structural exam of the thoracic spine.
Measured: Through study completion, which was an average of about 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start10 Oct 2019
- Primary completion13 Jan 2020
- Study completion14 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteopathic Manipulative TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randall Nydam, Midwestern University
- Investigators
- Randall Nydam, PhD, Principal investigator, Midwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04823637
- Sponsor's protocol ID
- AZ 1232
- Acronym
- USOMM
- Status last verified
- Mar 2021
- First submitted
- 25 Mar 2021
- Last updated
- 1 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chang S, Maddox J, Berg E, Kim K, Messier S, Swanson L, Dobrusin R, Stein AB, Nakken GN, Noble J, Nydam R. Evaluating for a correlation between osteopathic examination and ultrasonography on thoracic spine asymmetry. J Osteopath Med. 2021 Oct 13;122(1):31-43. doi: 10.1515/jom-2021-0020.
PubMed 34643344
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating for a Correlation Between Osteopathic Examination and Ultrasonography on Thoracic Spine Asymmetry
- ClinicalTrials.gov ID
- NCT04823637
- Acronym / sponsor ID
- USOMM / AZ 1232
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Midwestern UniversityUniversity, hospital or other
- Study start
- 10 Oct 2019 (actual)
- Primary completion
- 13 Jan 2020 (actual)
- Study completion
- 14 Jan 2021 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects are Midwestern University students who were recruited via email announcements, with responses recorded via secure Google Form that was accessible only to the Midwestern University network. The overall demographics of participants showed 31 (47.0%) males and 35 (53.0%) females. Race and ethnicity were not collected for the purpose of this study as it was not a variable being evaluated or investigated. The subjects' age range is 22-35 years of age, with the mean age as 26.61 (SD = 3.1) for males and 25.71 (SD = 2.7) for females. The BMI range is 15.9 - 36.9kg/m2, with the mean BMI as 24.13 (SD = 4.2) overall, 25.46 (SD = 3.5) for males and 22.95 (SD = 4.5) for females.
Key inclusion criteria (2 listed)
- First- and Second-year osteopathic medical students who received an email notification
- Masters program students who received an email notification
Key exclusion criteria (1 listed)
- A history of or currently diagnosed with scoliosis, spondylosis, spondylolisthesis, herniated disc, spinal fracture, or surgery to the spine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasonography vs Osteopathic manipulative medicine structural examStructural examination of the thoracic spine using ultrasound and osteopathic palpatory examination on skin. | Diagnostic test | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Derived from this study: PubMed 34643344Chang S, Maddox J, Berg E, Kim K, Messier S, Swanson L, Dobrusin R, Stein AB, Nakken GN, Noble J, Nydam R. Evaluating for a correlation between osteopathic examination and ultrasonography on thoracic spine asymmetry. J Osteopath Med. 2021 Oct 13;122(1):31-43. doi: 10.1515/jom-2021-0020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randall Nydam, PhD principal investigator
Midwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteopathic Manipulative Treatment and Ultrasonography, run by Midwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interexaminer reliability (time frame: Through study completion, which was an average of about 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04823637, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.