Segmental and Somatic DysfunctionNCT01394198
Correlation of Somatic Dysfunction With Gastrointestinal Endoscopic Findings
An observational study of Segmental and Somatic Dysfunction and Pathological Conditions, Signs and Symptoms, run by A.T. Still University of Health Sciences at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Segmental and Somatic Dysfunction, Pathological Conditions, Signs and Symptoms, Ectopic Intestinal Mucosa
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Kirksville College of Osteopathic Medicine Family Practice Clinic
Kirksville, Missouri, 63501
About this study
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.
Read the 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.
- 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
- Medical subject headings
- Pathological Conditions, Signs and Symptoms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2011 (estimated)
- Study startMar 2011
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Segmental and Somatic DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- A.T. Still University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen T Snider, D.O., Principal investigator, Kirksville College of Osteopathic Medicine; AT Still University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01394198
- Sponsor's protocol ID
- 101123-001
- Status last verified
- Sep 2018
- First submitted
- 27 Jun 2011
- Last updated
- 27 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27214772
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Somatic Dysfunction With Gastrointestinal Endoscopic Findings
- ClinicalTrials.gov ID
- NCT01394198
- Acronym / sponsor ID
- 101123-001
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- A.T. Still University of Health SciencesUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 14 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2018.
- Derived from this study: PubMed 27214772Snider 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen T Snider, D.O. principal investigator
Kirksville College of Osteopathic Medicine; AT Still University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Segmental and Somatic Dysfunction and Pathological Conditions, Signs and Symptoms, run by A.T. Still University of Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01394198, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2018.