Effect of Cranial Manipulation on ANS Activity

NCT02785796 | Completed

• 1 other identifier: 001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

In osteopathy is generally believed that the cranial bones are equipped with an inherent mobility, which like any other joint may face restrictions on movement and then somatic dysfunction. For this reason, different techniques are used with the aim of increasing the mobility of the cranial bones. Some of these have been effective in modifying physiological parameters related to the activity of the autonomic nervous system, such as cardiac function or sleep latency. This study aims to test the effectiveness of a specific craniosacral technique, compression of the fourth ventricle CV4, using the salivary marker alpha amylase, which is sensitive to changes in the activity of the autonomic nervous system. To patients recruited from students of AIMO, we will ask to provide saliva samples before and after CV4 treatment. In particular, saliva will be collected four times per patient: at the initial time, after administration of a stressful event (hand immersion in ice water), immediately after application of the CV4 technique and thirty minutes after the application of the CV4 technique. For each sample of saliva detected, we will proceed to measure the activity of alpha amylase and flow rate, variables sensitive to the activation of the autonomic nervous system.

Conditions

Alpha Amylase; Manipulation, Osteopathic

Outcome Measures

Primary Outcomes (6)

• alpha amylase activity measured by enzymatic assay

  measurement before the technique application

• salivary flow rate

  measurement before the technique application

• alpha amylase activity measured by enzymatic assay

  measurement immediately after the technique application

• alpha amylase activity measured by enzymatic assay

  measurement 30 minutes after the technique application

• salivary flow rate

  measurement immediately after the technique application

• salivary flow rate

  measurement 30 minutes after the technique application

Study Arms (3)

CV4

EXPERIMENTAL

The practitioner will contact the participant's occiput (lateral to the external occipital protuberances, but medial to the occipital-mastoid suture) with his or her thenar eminences. When no cranial mobility will be found, operators will be free to use any kind of technique to enhance the cranial movement before CV4 procedure. Once the practitioner will detect the CRI, the practitioner will resist the flexion phase of the CRI and exaggerate the extension phase. This compressive pressure will be maintained until the CRI stopped, and the still-point is reached. The still-point will be held until the CRI return, at which point the compressive pressure will be slowly release

Other: CV4

sham technique

PLACEBO COMPARATOR

The operator will overlap the hands so that the thumbs formed a "V". The operator's thenar eminences will contact the occiput very lightly well below the positioning used in the CV4 procedure but with no pressure on the occiput between the occipitomastoid sutures. Once placement will be achieved, the operator's hands will remain motionless for 10 min. Finally, the practitioner's hands will be gently removed and the participant's head will be placed on the table for both procedures

Other: SHAM TECHNIQUE

Control

NO INTERVENTION

The control group will not receive ant type of treatment: subject just stay quietly in supine position in ambulatory room for ten minutes

Interventions

CV4 OTHER

CV4

SHAM TECHNIQUE OTHER

sham technique

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• consensus signed

You may not qualify if:

• oral contraceptive
• drugs assumption
• pathology of oral cavity
• failure to comply the directives

Sponsors & Collaborators

• Accademia Italiana Medicina Osteopatica: lead

Study Sites (1)

AIMO

Saronno, Varese, 21047, Italy

Location

Related Publications (2)

• Cutler MJ, Holland BS, Stupski BA, Gamber RG, Smith ML. Cranial manipulation can alter sleep latency and sympathetic nerve activity in humans: a pilot study. J Altern Complement Med. 2005 Feb;11(1):103-8. doi: 10.1089/acm.2005.11.103.

  PMID: 15750368 BACKGROUND

• Nater UM, Rohleder N. Salivary alpha-amylase as a non-invasive biomarker for the sympathetic nervous system: current state of research. Psychoneuroendocrinology. 2009 May;34(4):486-96. doi: 10.1016/j.psyneuen.2009.01.014. Epub 2009 Feb 26.

  PMID: 19249160 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2016
• First Posted: May 30, 2016
• Study Start: May 1, 2016
• Primary Completion: May 1, 2016
• Study Completion: October 1, 2016
• Last Updated: January 26, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)