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NCT03888456 Clinical Trial

Effects of OMT on ANS: a Thermography Study

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03888456
Other study ID # COME-02-18
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 26, 2019
Est. completion date July 23, 2019

Study information
Verified date July 2019
Source Come Collaboration
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date July 23, 2019
Est. primary completion date June 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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 Design

Related Conditions & MeSH terms

  • Autonomic Nervous System Imbalance
  • Healthy

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

Locations
Country Name City State
Italy University of Chieti Chieti

Sponsors (3)
Lead Sponsor Collaborator
Come Collaboration Chinesis IFOP, Università degli Studi 'G. d'Annunzio' Chieti e Pescara

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary temperature variability of the autonomic nervous system measured by temperature variability of the face 1 week
Secondary skin conductance pre-post changes of physiological parameter of electrodermal skin response 1 week
Secondary heart rate variability pre-post changes of HRV 1 week
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