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Ultrasound Evaluation of Changes in Diaphragm Induced by Osteopathic Manipulative Techniques

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02801058
Recruitment Status : Completed
First Posted : June 15, 2016
Last Update Posted : June 17, 2016
Information provided by (Responsible Party):
Simone Scarlata, Scarlata, Simone, M.D.

Brief Summary:

A wide number of osteopathic techniques focusing on diaphragm have been proposed but, although systematically and efficiently used, there is a general lack of evidences able to clarify how and to which extent osteopathic manipulative treatment (OMT) on diaphragm is effective and determines a modification in muscles contractility and motion as well as an objective determination of the benefit on the patients receiving treatment.

This study therefore aims at investigating whether, and how, a single session of selected osteopathic diaphragmatic techniques are able to affect muscle motility and thickness, assessed by ultrasounds, in a sample of healthy subjects and to compare results versus a group receiving a sham therapy and another one of non-treated subjects.

Condition or disease Intervention/treatment Phase
Diaphragm Respiratory Muscles Osteopathic Medicine Ultrasonography Other: Osteopathic manipulative treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ultrasound Evaluation of Changes in Diaphragmatic Motion and Contractility Induced by Osteopathic Manipulative Techniques: a Prospective, Randomized, Double Blinded, Case vs Sham vs Control Clinical Trial.
Study Start Date : September 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
No Intervention: Control
Simple observation
Sham Comparator: Shame
Light touch manipulative simulation
Other: Osteopathic manipulative treatment
Osteopathic manipulative techniques on thoracic diaphragm

Experimental: Treatment
Osteopathic manipulative techniques on the abdominal diaphragm
Other: Osteopathic manipulative treatment
Osteopathic manipulative techniques on thoracic diaphragm

Primary Outcome Measures :
  1. Assessing the change in diaphragm mobility induced by osteopathic treatment [ Time Frame: 15 min ]

Secondary Outcome Measures :
  1. Assessing the correlation between osteopathic manual evaluation of diaphragmatic motion and ultrasound measures of mobility [ Time Frame: 15 min ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • age below 18 years old

Exclusion Criteria:

  • Any current or previous disease, pharmacological treatment or condition contraindicating the manual approach.
  • Absence of signed informed consent

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Responsible Party: Simone Scarlata, Scarlata, Simone, M.D. Identifier: NCT02801058    
Other Study ID Numbers: SS-2016-1
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: June 17, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Simone Scarlata, Scarlata, Simone, M.D.:
Osteopathic manipulative treatment
Abdominal Diaphragm mobility
Thoracic Ultrasounds