Ultrasonography Clinical Trial
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.
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.
Status | Completed |
Enrollment | 66 |
Est. completion date | March 2016 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Scarlata, Simone, M.D. |
Bordoni B, Zanier E. Anatomic connections of the diaphragm: influence of respiration on the body system. J Multidiscip Healthc. 2013 Jul 25;6:281-91. doi: 10.2147/JMDH.S45443. Print 2013. — View Citation
da Silva RC, de Sá CC, Pascual-Vaca ÁO, de Souza Fontes LH, Herbella Fernandes FA, Dib RA, Blanco CR, Queiroz RA, Navarro-Rodriguez T. Increase of lower esophageal sphincter pressure after osteopathic intervention on the diaphragm in patients with gastroesophageal reflux. Dis Esophagus. 2013 Jul;26(5):451-6. doi: 10.1111/j.1442-2050.2012.01372.x. Epub 2012 Jun 7. — View Citation
Noll DR, Degenhardt BF, Johnson JC, Burt SA. Immediate effects of osteopathic manipulative treatment in elderly patients with chronic obstructive pulmonary disease. J Am Osteopath Assoc. 2008 May;108(5):251-9. — View Citation
Noll DR, Degenhardt BF, Morley TF, Blais FX, Hortos KA, Hensel K, Johnson JC, Pasta DJ, Stoll ST. Efficacy of osteopathic manipulation as an adjunctive treatment for hospitalized patients with pneumonia: a randomized controlled trial. Osteopath Med Prim Care. 2010 Mar 19;4:2. doi: 10.1186/1750-4732-4-2. — View Citation
Sferrazza Papa GF, Pellegrino GM, Di Marco F, Imeri G, Brochard L, Goligher E, Centanni S. A Review of the Ultrasound Assessment of Diaphragmatic Function in Clinical Practice. Respiration. 2016 May 25;91(5). [Epub ahead of print] — View Citation
Zanotti E, Berardinelli P, Bizzarri C, Civardi A, Manstretta A, Rossetti S, Fracchia C. Osteopathic manipulative treatment effectiveness in severe chronic obstructive pulmonary disease: a pilot study. Complement Ther Med. 2012 Feb-Apr;20(1-2):16-22. doi: 10.1016/j.ctim.2011.10.008. Epub 2011 Nov 27. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessing the change in diaphragm mobility induced by osteopathic treatment | 15 min | Yes | |
Secondary | Assessing the correlation between osteopathic manual evaluation of diaphragmatic motion and ultrasound measures of mobility | 15 min | Yes |
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