NCT01394198

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 27, 2011

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 14, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

September 27, 2018

Status Verified

September 1, 2018

Enrollment Period

2.7 years

First QC Date

June 27, 2011

Last Update Submit

September 26, 2018

Conditions

Keywords

Osteopathic Manipulative Medicine (OMM)Neuromuscular Medicine (NMM)Somatic DysfunctionCorrelational StudyEndoscopy

Outcome Measures

Primary Outcomes (1)

  • 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.

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kirksville College of Osteopathic Medicine Family Practice Clinic

Kirksville, Missouri, 63501, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Pathological Conditions, Signs and Symptoms

Study Officials

  • Karen T Snider, D.O.

    Kirksville College of Osteopathic Medicine; AT Still University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2011

First Posted

July 14, 2011

Study Start

March 1, 2011

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

September 27, 2018

Record last verified: 2018-09

Locations