An interventional study of CV4 and ST in Healthy and Osteopathic Manipulation, sponsored by Istituto Superiore di Osteopatia di Milano. Completed at 1 site in Italy. Open to participants aged 20 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-08.
Sponsored by Istituto Superiore di Osteopatia di Milano · Not applicable, Interventional, and Basic science
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.
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.
Istituto Superiore di Osteopatia di Milano is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 · Other: Sham CV4
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 · Other: Sham ST
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.
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
the sham intervention was performed by placing the hands in the same position as the corresponding active technique, applying a light touch
The sham intervention was performed by placing the hands in the same position as the corresponding active technique, applying a light touch
Alpha EEG
Quantitative EEG recording of alpha wave (8-12Hz)
Time frame: 50 minutes
Plan to share: No
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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Istituto Superiore di Osteopatia di Milano