Effects of OMT on ANS: a Thermography Study

July 23, 2019 updated by: Come Collaboration

Effects of Osteopathic Manipulative Treatment on Autonomic Nervous System: a Thermography Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Chieti, Italy, 66100
        • University of Chieti

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
temperature
Time Frame: 1 week
variability of the autonomic nervous system measured by temperature variability of the face
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
skin conductance
Time Frame: 1 week
pre-post changes of physiological parameter of electrodermal skin response
1 week
heart rate variability
Time Frame: 1 week
pre-post changes of HRV
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Come Collaboration

Collaborators

Università degli Studi 'G. d'Annunzio' Chieti e Pescara
Chinesis IFOP

Investigators

  • Principal Investigator: Francesco Cerritelli, Come Collaboration

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2019

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

July 23, 2019

Study Registration Dates

First Submitted

March 21, 2019

First Submitted That Met QC Criteria

March 22, 2019

First Posted (Actual)

March 25, 2019

Study Record Updates

Last Update Posted (Actual)

July 24, 2019

Last Update Submitted That Met QC Criteria

July 23, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • COME-02-18

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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