Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of OMT on ANS: a Thermography Study

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.
 
ClinicalTrials.gov Identifier: NCT03888456
Recruitment Status : Completed
First Posted : March 25, 2019
Last Update Posted : July 24, 2019
Sponsor:
Collaborators:
Università degli Studi 'G. d'Annunzio' Chieti e Pescara
Chinesis IFOP
Information provided by (Responsible Party):
Come Collaboration

Brief Summary:
the study will investigate the effect of a specific type of touch intervention on the activity of autonomic nervous system measured using thermography

Condition or disease Intervention/treatment Phase
Autonomic Nervous System Imbalance Healthy Other: osteopathic treatment Other: sham Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: randomised placebo controlled crossover study
Masking: Double (Participant, Outcomes Assessor)
Masking Description: participants will be blindly assigned to study or control arm using a computer-based random sequence generation and seal envelop
Primary Purpose: Basic Science
Official Title: Effects of Osteopathic Manipulative Treatment on Autonomic Nervous System: a Thermography Study
Actual Study Start Date : March 26, 2019
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : July 23, 2019

Arm Intervention/treatment
Experimental: study
participants will receive a single touch intervention based on osteopathic assessment and treatment
Other: osteopathic treatment
the intervention will be based on 2 phases: 1) assessment to identify areas with somatic dysfunction, 2) treatment to improve the function of the area identified

Other: sham
the sham intervention will consists of 2 overlapping phases as the intervention group but without applying any technique

Sham Comparator: Control
participants will receive a single touch sham intervention mimicking the intervention
Other: osteopathic treatment
the intervention will be based on 2 phases: 1) assessment to identify areas with somatic dysfunction, 2) treatment to improve the function of the area identified

Other: sham
the sham intervention will consists of 2 overlapping phases as the intervention group but without applying any technique




Primary Outcome Measures :
  1. temperature [ Time Frame: 1 week ]
    variability of the autonomic nervous system measured by temperature variability of the face


Secondary Outcome Measures :
  1. skin conductance [ Time Frame: 1 week ]
    pre-post changes of physiological parameter of electrodermal skin response

  2. heart rate variability [ Time Frame: 1 week ]
    pre-post changes of HRV



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • adults above 18y and below 35y
  • without any congenital, genetical and chronic disease
  • without any symptomatology

Exclusion Criteria:

  • congenital, genetical and chronic disease
  • neurological, cardiovascular, psychiatric disease
  • acute pain
  • paediatric patients
  • adults over 35 years old

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03888456


Locations
Layout table for location information
Italy
University of Chieti
Chieti, Italy, 66100
Sponsors and Collaborators
Come Collaboration
Università degli Studi 'G. d'Annunzio' Chieti e Pescara
Chinesis IFOP
Investigators
Layout table for investigator information
Principal Investigator: Francesco Cerritelli Come Collaboration
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Come Collaboration
ClinicalTrials.gov Identifier: NCT03888456    
Other Study ID Numbers: COME-02-18
First Posted: March 25, 2019    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No