The Effect of CV4 and Sacral Technique on the Alpha Bands Power

NCT04492917 | Completed

• 1 other identifier: CV4 Alpha Band
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Compression of the fourth ventricle (CV4), is the most studied cranial technique, commonly used by Osteopathy in Cranial Field practitioners. Evidence attributed to CV4 some effects on nervous system functions, however, the supporting evidence for CV4 clinical benefits is promising but still poor. The osteopathic tradition considers the sacrum linked to the cranium through anatomical and functional connections. To our knowledge, no studies explored the potential effect of a sacral technique on brain activity as an indicator of a neurophysiological connection between the occiput and sacrum. This study aims to explore this effect by measuring the alpha-band activity during the application of a sacral technique (ST) compared to the CV4 application.

Conditions

Healthy; Osteopathic Manipulation

Keywords

EEG; Alpha Rhythm; CV4

Outcome Measures

Primary Outcomes (1)

• Alpha EEG

  Quantitative EEG recording of alpha wave (8-12Hz)

  50 minutes

Study Arms (2)

Cranial Technique CV4

EXPERIMENTAL

All subjects received a combination of the active technique (CV4) and the corresponding sham technique (shamCV4). CV4: the lateral angles of the occipital squama are manually approximated slightly exaggerating the posterior convexity of the occiput and taking the cranium into sustained extension. The technique ended when the osteopath perceived the still point, a condition in which the balanced membranous or ligamentous tension is achieved. ShamCV4: sham intervention was performed by placing the hands in the same position as the corresponding active technique, applying a light touch

Other: CV4; Other: Sham CV4

Sacral Technique ST

ACTIVE COMPARATOR

All subjects received a combination of the active technique (ST) and the corresponding sham technique (sST). ST: The subject was lying in the supine position, while the osteopath positioned the index and middle fingers of the caudal hand on either side of the subject's sacrum. Then establishes a point of balance between the coccyx and the vertex facilitating the sacral extension until the achievement of the still point. ShamST: sham intervention was performed by placing the hands in the same position of the corresponding active technique, applying a light touch

Other: ST; Other: Sham ST

Interventions

CV4 OTHER

The osteopath was sitting at the head of the examination table, with the subject lying supine. The osteopath approximated with the hands the lateral angles of the occipital squama, taking the cranium into sustained extension. The technique ended when the osteopath perceived the still point, a condition in which the balanced membranous or ligamentous tension is achieved.

Cranial Technique CV4

ST OTHER

The subject was lying in the supine position, while the osteopath positioned the index and middle fingers of the caudal hand on either side of the subject's sacrum. Then establishes a point of balance between the coccyx and the vertex facilitating the sacral extension until the achievement of the still point

Sacral Technique ST

Sham CV4 OTHER

the sham intervention was performed by placing the hands in the same position as the corresponding active technique, applying a light touch

Cranial Technique CV4

Sham ST OTHER

The sham intervention was performed by placing the hands in the same position as the corresponding active technique, applying a light touch

Sacral Technique ST

Eligibility Criteria

• Age: 20 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age
• Subjects had to sleep for at least 6 hours the night before the experiment

You may not qualify if:

• Use of Psychoactive or Psychotropic Substances
• Cerebrovascular diseases
• Recent headaches
• Use of nicotine in the 24 hours prior to the quantitative EEG registration
• Use of alcohol in the previous 12 hours.

Sponsors & Collaborators

• Istituto Superiore di Osteopatia di Milano: lead

Study Sites (1)

Centro di Medicina Osteopatica

Milan, 20126, Italy

Location

Study Officials

• Pisa

  Istituto Superiore di Osteopatia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 27, 2020
• First Posted: July 30, 2020
• Study Start: September 10, 2018
• Primary Completion: October 25, 2018
• Study Completion: October 25, 2018
• Last Updated: April 8, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)