Clinical trial NCT01394198: Correlation of Somatic Dysfunction With Gastrointestinal Endoscopic Findings
Official title: Correlation of Somatic Dysfunction With Gastrointestinal Endoscopic Findings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Segmental and Somatic Dysfunction
Pathological Conditions, Signs and Symptoms
Ectopic Intestinal Mucosa
Keywords: Osteopathic Manipulative Medicine (OMM)
Neuromuscular Medicine (NMM)
Somatic Dysfunction
Correlational Study
Endoscopy
Lead sponsor: A.T. Still University of Health Sciences
Sponsor class: OTHER
First posted: 2011-07-14
Enrollment: 70
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Osteopathic structural exam findings of somatic dysfunction
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Kirksville
country: United States
facility: Kirksville College of Osteopathic Medicine Family Practice Clinic
state: Missouri
Study officials:
affiliation: Kirksville College of Osteopathic Medicine; AT Still University
name: Karen T Snider, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Snider KT, Schneider RP, Snider EJ, Danto JB, Lehnardt CW, Ngo CS, Johnson JC, Sheneman TA. Correlation of Somatic Dysfunction With Gastrointestinal Endoscopic Findings: An Observational Study. J Am Osteopath Assoc. 2016 Jun 1;116(6):358-69. doi: 10.7556/jaoa.2016.076.