Correlation of Somatic Dysfunction With Gastrointestinal Endoscopic Findings

Pathological Conditions, Signs and Symptoms Clinical Trial

Official title:

Correlation of Somatic Dysfunction With Gastrointestinal Endoscopic Findings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01394198
• Other study ID #: 101123-001
• Status: Completed
• Start date: March 2011
• Est. completion date: November 2013

Study information

• Verified date: September 2018
• Source: A.T. Still University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ectopic Intestinal Mucosa
• Pathological Conditions, Signs and Symptoms
• Segmental and Somatic Dysfunction
• Signs and Symptoms

Locations

Country	Name	City	State
United States	Kirksville College of Osteopathic Medicine Family Practice Clinic	Kirksville	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
A.T. Still University of Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Osteopathic structural exam findings of somatic dysfunction	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.