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

NCT ID: NCT04492917

Last Updated: 2022-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-10
• Study Completion Date: 2018-10-25

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.

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.

Conditions

Healthy; Osteopathic Manipulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

CV4

Intervention Type: 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.

Sham CV4

Intervention Type: 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

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

Group Type: ACTIVE_COMPARATOR

ST

Intervention Type: 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

Sham ST

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istituto Superiore di Osteopatia di Milano

OTHER

Sponsor Role: lead

Responsible Party

Viviana Pisa

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pisa

Role: PRINCIPAL_INVESTIGATOR

Istituto Superiore di Osteopatia

Locations

Centro di Medicina Osteopatica

Milan, , Italy

Countries

Italy

Other Identifiers

CV4 Alpha Band

Identifier Type: -

Identifier Source: org_study_id