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

I

Istituto Superiore di Osteopatia di Milano

Status

Completed

Conditions

Healthy
Osteopathic Manipulation

Treatments

Other: CV4
Other: Sham CV4
Other: Sham ST
Other: ST

Study type

Interventional

Funder types

Other

Identifiers

NCT04492917
CV4 Alpha Band

Details and patient eligibility

About

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.

Full 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.

Enrollment

46 patients

Sex

All

Ages

20 to 30 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

46 participants in 2 patient groups

Cranial Technique CV4
Experimental group
Description:
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
Treatment:
Other: Sham CV4
Other: CV4
Sacral Technique ST
Active Comparator group
Description:
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
Treatment:
Other: Sham ST
Other: ST

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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