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Completed

NCT Number: NCT04492917

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

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.

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Key information

Conditions

Healthy Osteopathic Manipulation

Age range

20 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro di Medicina Osteopatica

Milan, 20126, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

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

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

Primary outcomes

  1. Alpha EEG

    Time frame: 50 minutes

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

Sponsors and collaborators

Lead sponsor

Istituto Superiore di Osteopatia di Milano

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 30, 2020
Registry last updated
Apr 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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