None listed
Conditions
Brief summary
The hypothesis of the study is that cranial osteopathy (CO) can change the diameter of the optic nerve sheath (ONSD). And since the ONSD is an indirect measure of the intracranial pressure (ICP), CO can also change the ICP. To demonstrate the effect of CO we need to cause variations in the DVNO. Previous studies show that placing the subject for 3.5 hours on an inclined plane at -12º (head down tilt) increases DVNO. We will also test the jugular section area, heart rate and blood pressure, because studies show changes in these variables. PROCEDURE PROTOCOL On the day of the intervention, the subject will first lie down on a stretcher at a 0º incline for 5 minutes. After these 5 minutes, all the measurements of the "T0" variables (ONSD, jugular section, blood pressure and pulse) will be taken. The subject will then be transferred to a stretcher at -12º head down tilt, where they will remain for 3.5 hours. During this time, the variables will be measured twice to verify that the withdrawal criteria are not met (at 1 hour and 2 hours). At 3.5 hours, the “T1” variables (ONSD, jugular section, blood pressure and pulse) will be measured; and then the placebo technique or the CO technique will be done for 15 minutes. At the end, the "T2" variables (ONSD, jugular section, blood pressure and pulse) will be measured.
Interventions
Number of times: The intervention is just one time.
The recruitment of the subjects was face to face between the patients and companions of the Burrel Martinez Center and Neuroburgas.
Subjects will spend 3.5 hours on -12º head down tilt.
Then the intervention will be carried out for 15 minutes. While the subjects remain -12º head down tilt
The intervention consists of the application of 3 cranial osteopathy techniques: the fronto-occipital technique, the bi-temporal technique and the biparietal
Number of times: The intervention is just one time. The recruitment of the subjects was face to face between the patients and companions of the Burrel Martinez Center and Neuroburgas. Subjects will spend 3.5 hours on -12º head down tilt. Then the intervention will be carried out for 15 minutes. While the subjects remain -12º head down tilt The intervention consists of the application of 3 cranial osteopathy techniques: the fronto-occipital technique, the bi-temporal technique and the biparietal technique. The techniques will be done consecutively, 6 seconds each up to a total of 15 minutes. Techniques description: The fronto-occipital technique is performed applying gentle pressure with one hand on the frontal and the other on the occipital The bitemporal technique is performed applying gentle pressure with one hand on the right temporal and the other on the left temporal The biparietal technique is performed by applying gentle pressure with one hand on both parietal bones along the sagittal suture. The osteopath (Angel Burrel Botaya) will deliver the intervention, he has minimum 5 years expertise. The trial refers to a single treatment. Baseline measurements, interventions and post-treatment measurement will be developed with the patients present during the whole time. They will not go out from the investigation room during the perfomance of the study. The completion or withdrawal from the study will be registered in a checklist, and it will be shown in the flow diagram of the sample.
Sponsors
ANGEL BURREL BOTAYA
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
20 Years to 53 Years
Healthy volunteers
Yes
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.
Outcome results
None listed