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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Osteopathic Manipulation
• Intervention / Treatment: Other: CV4; Other: Sham CV4; Other: ST; Other: Sham ST

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 Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20126
    • Centro di Medicina Osteopatica

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alpha EEG	Quantitative EEG recording of alpha wave (8-12Hz)	50 minutes

Collaborators and Investigators

• Sponsor: Istituto Superiore di Osteopatia di Milano
• Investigators: Principal Investigator: Pisa, Istituto Superiore di Osteopatia

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2018
• Primary Completion (Actual): October 25, 2018
• Study Completion (Actual): October 25, 2018

Study Registration Dates

• First Submitted: July 27, 2020
• First Submitted That Met QC Criteria: July 27, 2020
• First Posted (Actual): July 30, 2020

Study Record Updates

• Last Update Posted (Actual): April 8, 2022
• Last Update Submitted That Met QC Criteria: March 31, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: EEG; Alpha Rhythm; CV4
• Other Study ID Numbers: CV4 Alpha Band

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No