Effects of OMT on ANS: a Thermography Study
Effects of Osteopathic Manipulative Treatment on Autonomic Nervous System: a Thermography Study
1 other identifier
interventional
40
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2019
Shorter than P25 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
March 21, 2019
CompletedFirst Posted
Study publicly available on registry
March 25, 2019
CompletedStudy Start
First participant enrolled
March 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 23, 2019
CompletedJuly 24, 2019
July 1, 2019
3 months
March 21, 2019
July 23, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
temperature
variability of the autonomic nervous system measured by temperature variability of the face
1 week
Secondary Outcomes (2)
skin conductance
1 week
heart rate variability
1 week
Study Arms (2)
study
EXPERIMENTALparticipants will receive a single touch intervention based on osteopathic assessment and treatment
Control
SHAM COMPARATORparticipants will receive a single touch sham intervention mimicking the intervention
Interventions
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
the sham intervention will consists of 2 overlapping phases as the intervention group but without applying any technique
Eligibility Criteria
You may qualify if:
- adults above 18y and below 35y
- without any congenital, genetical and chronic disease
- without any symptomatology
You may not qualify if:
- congenital, genetical and chronic disease
- neurological, cardiovascular, psychiatric disease
- acute pain
- paediatric patients
- adults over 35 years old
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Come Collaborationlead
- Università degli Studi 'G. d'Annunzio' Chieti e Pescaracollaborator
- Chinesis IFOPcollaborator
Study Sites (1)
University of Chieti
Chieti, 66100, Italy
Related Publications (1)
Cerritelli F, Cardone D, Pirino A, Merla A, Scoppa F. Does Osteopathic Manipulative Treatment Induce Autonomic Changes in Healthy Participants? A Thermal Imaging Study. Front Neurosci. 2020 Aug 18;14:887. doi: 10.3389/fnins.2020.00887. eCollection 2020.
PMID: 33013294DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francesco Cerritelli
Come Collaboration
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- participants will be blindly assigned to study or control arm using a computer-based random sequence generation and seal envelop
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 21, 2019
First Posted
March 25, 2019
Study Start
March 26, 2019
Primary Completion
June 30, 2019
Study Completion
July 23, 2019
Last Updated
July 24, 2019
Record last verified: 2019-07