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

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

    • Missouri
      • Kirksville, Missouri, United States, 63501
        • Kirksville College of Osteopathic Medicine Family Practice Clinic

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

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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