NCT02801058

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable

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

September 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 15, 2016

Completed
Last Updated

June 17, 2016

Status Verified

June 1, 2016

Enrollment Period

3 months

First QC Date

June 9, 2016

Last Update Submit

June 16, 2016

Conditions

DiaphragmRespiratory MusclesOsteopathic MedicineUltrasonography

Keywords

Osteopathic manipulative treatmentAbdominal Diaphragm mobilityThoracic Ultrasounds

Outcome Measures

Primary Outcomes (1)

  • Assessing the change in diaphragm mobility induced by osteopathic treatment

    15 min

Secondary Outcomes (1)

  • Assessing the correlation between osteopathic manual evaluation of diaphragmatic motion and ultrasound measures of mobility

    15 min

Study Arms (3)

Control

NO INTERVENTION

Simple observation

Shame

SHAM COMPARATOR

Light touch manipulative simulation

Other: Osteopathic manipulative treatment

Treatment

EXPERIMENTAL

Osteopathic manipulative techniques on the abdominal diaphragm

Other: Osteopathic manipulative treatment

Interventions

Osteopathic manipulative treatmentOTHER

Osteopathic manipulative techniques on thoracic diaphragm

ShameTreatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age below 18 years old

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 23940419BACKGROUND

  • da Silva RC, de Sa CC, Pascual-Vaca AO, 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.

    PMID: 22676647BACKGROUND

  • 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.

    PMID: 20302619BACKGROUND

  • 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.

    PMID: 18519835BACKGROUND

  • 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.

    PMID: 22305244BACKGROUND

  • 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;91(5):403-11. doi: 10.1159/000446518. Epub 2016 May 25.

    PMID: 27216909BACKGROUND

MeSH Terms

Interventions

Manipulation, Osteopathic

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scarlata, Simone, M.D.

Study Record Dates

First Submitted

June 9, 2016

First Posted

June 15, 2016

Study Start

September 1, 2015

Primary Completion

December 1, 2015

Study Completion

March 1, 2016

Last Updated

June 17, 2016

Record last verified: 2016-06