Correlation of Somatic Dysfunction With Gastrointestinal Endoscopic Findings

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
A.T. Still University of Health Sciences
ClinicalTrials.gov Identifier:
NCT01394198
First received: June 27, 2011
Last updated: January 7, 2014
Last verified: June 2011
  Purpose

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.


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

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Correlation of Somatic Dysfunction With Gastrointestinal Endoscopic Findings

Resource links provided by NLM:


Further study details as provided by A.T. Still University of Health Sciences:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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.


Enrollment: 70
Study Start Date: March 2011
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01394198

Locations
United States, Missouri
Kirksville College of Osteopathic Medicine Family Practice Clinic
Kirksville, Missouri, United States, 63501
Sponsors and Collaborators
A.T. Still University of Health Sciences
Investigators
Principal Investigator: Karen T Snider, D.O. Kirksville College of Osteopathic Medicine; AT Still University
  More Information

No publications provided

Responsible Party: A.T. Still University of Health Sciences
ClinicalTrials.gov Identifier: NCT01394198     History of Changes
Other Study ID Numbers: 101123-001
Study First Received: June 27, 2011
Last Updated: January 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by A.T. Still University of Health Sciences:
Osteopathic Manipulative Medicine (OMM)
Neuromuscular Medicine (NMM)
Somatic Dysfunction
Correlational Study
Endoscopy

Additional relevant MeSH terms:
Signs and Symptoms

ClinicalTrials.gov processed this record on October 20, 2014