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

Sponsor

Istituto Superiore di Osteopatia di Milano (Other)

Overall Status

Completed

CT.gov ID

NCT04492917

Collaborator

(none)

Enrollment

Location

Arms

1.5

Actual Duration (Months)

31.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Osteopathic Manipulation	Other: CV4 Other: ST Other: Sham CV4 Other: Sham ST	N/A

Detailed Description

Forty healthy volunteers will receive a combination of CV4 technique, CV4 sham, sacral technique (ST) and sacral sham technique (sST).

Each session, split by a 4-hour washout, will start with 10 min of no treatment (resting state), followed by two randomized interventions. Alpha EEG will be continuously recorded during each intervention and 10 min after, for a total of approximately 50-60 min per session.

Study Design

Study Type:

Interventional

Actual Enrollment :

46 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Basic Science

Official Title:

The Effect of CV4 and Sacral Technique on the Alpha Bands Power: A Randomized Controlled Trial

Actual Study Start Date :

Sep 10, 2018

Actual Primary Completion Date :

Oct 25, 2018

Actual Study Completion Date :

Oct 25, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cranial Technique CV4 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 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. Other: Sham CV4 the sham intervention was performed by placing the hands in the same position as the corresponding active technique, applying a light touch
Active Comparator: Sacral Technique ST 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 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 Other: Sham ST The sham intervention was performed by placing the hands in the same position as the corresponding active technique, applying a light touch

Arm

Intervention/Treatment

Experimental: Cranial Technique CV4

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

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.

Other: Sham CV4

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

Active Comparator: Sacral Technique ST

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

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

Other: Sham ST

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

Outcome Measures

Primary Outcome Measures

Alpha EEG [50 minutes]
Quantitative EEG recording of alpha wave (8-12Hz)

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centro di Medicina Osteopatica	Milan		Italy	20126

Sponsors and Collaborators

Istituto Superiore di Osteopatia di Milano

Investigators

Principal Investigator: Pisa, Istituto Superiore di Osteopatia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Viviana Pisa, Principal Investigator, Istituto Superiore di Osteopatia di Milano

ClinicalTrials.gov Identifier:

NCT04492917

Other Study ID Numbers:

CV4 Alpha Band

First Posted:

Jul 30, 2020

Last Update Posted:

Apr 8, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Viviana Pisa, Principal Investigator, Istituto Superiore di Osteopatia di Milano

EEG

Alpha Rhythm

CV4

Study Results

No Results Posted as of Apr 8, 2022