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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04492917
• Other study ID #: CV4 Alpha Band
• Status: Completed
• Phase: N/A
• Start date: September 10, 2018
• Est. completion date: October 25, 2018

Study information

• Verified date: March 2022
• Source: Istituto Superiore di Osteopatia di Milano
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: October 25, 2018
• Est. primary completion date: October 25, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy
• Osteopathic Manipulation

Intervention

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.
• 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
• Sham CV4
the sham intervention was performed by placing the hands in the same position as the corresponding active technique, applying a light touch
• Sham ST
The sham intervention was performed by placing the hands in the same position as the corresponding active technique, applying a light touch

Locations

Country	Name	City	State
Italy	Centro di Medicina Osteopatica	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Superiore di Osteopatia di Milano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alpha EEG	Quantitative EEG recording of alpha wave (8-12Hz)	50 minutes