Correlation of Somatic Dysfunction With Gastrointestinal Endoscopic Findings
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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 |
|---|
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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 |
- 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.
| Estimated Enrollment: | 20 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
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 |
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.
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| Contact: Kenneth L Pamperin, M.S., CCRA | 660-626-2444 | kpamperin@atsu.edu |
| Contact: Celia Hagan, BSN, CCRC | 660-626-2443 | CHagan@atsu.edu |
| United States, Missouri | |
| Kirksville College of Osteopathic Medicine Family Practice Clinic | Recruiting |
| Kirksville, Missouri, United States, 63501 | |
| Contact: Robert P Schneider, D.O., FAAFP 660-626-2537 | |
| Contact: Patricia Lyons 660-626-2304 PLyons@atsu.edu | |
| Principal Investigator: Robert P. Schneider, D.O., FAAFP | |
| Sub-Investigator: Karen Snider, D.O. | |
| Sub-Investigator: Eric Snider, D.O. | |
| Sub-Investigator: Chris Ngo, D.O. | |
| Sub-Investigator: Jane C. Johnson, M.A. | |
| Principal Investigator: | Robert P Schneider, D.O., FAAFP | 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: | February 3, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by A.T. Still University of Health Sciences:
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Osteopathic Manipulative Medicine (OMM) Neuromuscular Medicine (NMM) Somatic Dysfunction Correlational Study Endoscopy |
Additional relevant MeSH terms:
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Signs and Symptoms Cardiac Complexes, Premature Arrhythmias, Cardiac |
Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 23, 2013