The effect of cranial osteopathy on optic nerve sheath diameter in healthy volunteers: randomized crossover clinical trial.

Not Applicable

Completed

• Conditions: Increased optic nerve sheath diamether (ONSD); Raised intracranial pressure; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation; Neurological - Other neurological disorders

• Registration Number: ACTRN12622000691741
• Lead Sponsor: ANGEL BURREL BOTAYA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-12
• Study Completion: 2022-08-29
• Last Update Posted: 5 September 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

BMI less than 30

Exclusion Criteria

Any disease that affects the intracranial pressure (ICP), the optic nerve or the intraocular pressure. Such as head trauma, stroke, tumors, glaucoma, diabetes, diagnosis of neurological disease, history of metabolic disease, history of cardiovascular, rheumatic, oncological disease, taking medication that affects cerebrospinal fluid (CSF) or intraocular pressure (IOP), history of increased ICP or IOP, history of dizziness, headache or vertigo in the last 4 weeks. Severe orthostatic intolerance. Taking any medication. Diopters of more than +5 or less than -6. Vulnerable population such as pregnant women, lactating women or people unable to give their consent will also be excluded.
Exclusion criteria will be if the blood pressure measurements show a diastolic pressure greater than 90 mmHg, or less than 50 mmHg; and a systolic greater than 150mmHg, or less than 100mmHg; or a heart rate greater than 100 beats/min, or less than 50 beats/min. as well as an initial optic nerve diameter greater than 6 mm.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
OPTIC NERVE SHEATH DIAMETHER (ONSD) changes. measure in tenths of a millimeter.<br>Optic nerve sheath diamether will be measured with an ultrasound device (Siemens, sonoline, adara)<br>No known adverse effects<br>The ONSD of the right and left eye will be measured.<br>Two measurements will be taken from each eye.[The measures will be taken:<br>T0: After being 5 minutes lying down at 0 degrees<br>T1: After 3.5 hours at -12º tilt head down<br>T2: After applying the technique or the placebo 15 minutes (remaining -12º tilt head down, primary endpoint)<br>]