- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01394198
Correlation of Somatic Dysfunction With Gastrointestinal Endoscopic Findings
September 26, 2018 updated by: A.T. Still University of Health Sciences
The purpose of this study is to correlate the link between palpatory findings of somatic dysfunction and gastrointestinal endoscopic evidence of changes in mucosa.
The investigators' hypothesis is that there is a direct connection between somatic palpatory changes and intestinal mucosal changes via a somatovisceral/viscerosomatic mechanism.
Study Overview
Status
Completed
Detailed Description
The study protocol is limited to an extra physical examination (the focused structural exam) prior to a scheduled routine or diagnostic endoscopy.
Immediately prior to the scheduled endoscopy, subjects enrolled in the study will be palpated by a Neuromuscular Medicine (NMM)/Osteopathic Manipulative Medicine (OMM) specialist for spinal tenderness, tissue texture changes and asymmetry or restricted range of motion as well as tenderness of Chapman points.
The entire spine from the occipitoatlantal joint to the sacrum will be evaluated along with specific intercostal abdominal and lower extremity areas.
The positive structural examination findings of spinal tenderness, tissue texture changes and asymmetry or restricted range of motion will be compared to the visual and pathological findings recorded in the operative report of the endoscopy procedure and the pathological report of any biopsies obtained during the endoscopic procedure.
Study Type
Observational
Enrollment (Actual)
70
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Missouri
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Kirksville, Missouri, United States, 63501
- Kirksville College of Osteopathic Medicine Family Practice Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who are 21 years of age or older, of the Kirksville College of Osteopathic Family Medicine Clinic, and are scheduled for upper or lower endoscopy based on clinical symptomology or for routine screening based on age or risk factors.
Description
Inclusion Criteria:
- Patients already scheduled for upper or lower endoscopy at Kirksville Family Medicine Clinic
- Must be 21 years of age or older
- Subjects must be able to lie in the prone position for 30 minutes
Exclusion Criteria:
- Subjects cannot have history of spinal fractures or surgical intervention of the spine that could alter the palpatory findings of the spinal and paraspinal regions
- Subjects who are wards of the state or are unable to sign the consent form on their own behalf will be excluded
- Subjects will be excluded if they are unable to lie prone for 30 minutes
- Subjects will be excluded if they are not already scheduled for an endoscopy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Osteopathic structural exam findings of somatic dysfunction
Time Frame: Structural exam will be conducted prior to the scheduled endoscopy on the same day. The results will be recorded on a somatic dysfunction findings worksheet during the exam. This exam will only occur one time on the day of the endoscopy.
|
A musculoskeletal exam will be done by a Neuromuscular Medicine (NMM)/Osteopathic Manipulative Medicine (OMM) specialist for spinal tenderness, tissue texture changes, asymmetry, and restricted range of motion as well as tenderness of Chapman Points.
The entire spine from the occipitoatlantal joint to the sacrum will be evaluated along with specific intercostal abdominal and lower extremity areas.
The exam will identify whether tenderness, tissue texture changes, asymmetry, and range of motion restrictions exist at each of the vertebral segments.
|
Structural exam will be conducted prior to the scheduled endoscopy on the same day. The results will be recorded on a somatic dysfunction findings worksheet during the exam. This exam will only occur one time on the day of the endoscopy.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Karen T Snider, D.O., Kirksville College of Osteopathic Medicine; AT Still University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Actual)
November 1, 2013
Study Completion (Actual)
November 1, 2013
Study Registration Dates
First Submitted
June 27, 2011
First Submitted That Met QC Criteria
July 13, 2011
First Posted (Estimate)
July 14, 2011
Study Record Updates
Last Update Posted (Actual)
September 27, 2018
Last Update Submitted That Met QC Criteria
September 26, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 101123-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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