Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000691741
Ethics application status
Approved
Date submitted
15/02/2022
Date registered
12/05/2022
Date last updated
30/08/2022
Date data sharing statement initially provided
12/05/2022
Date results information initially provided
29/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of cranial osteopathy on optic nerve sheath diameter in healthy volunteers: randomized crossover clinical trial.
Scientific title
The effect of cranial osteopathy on optic nerve sheath diameter in healthy volunteers: randomized crossover clinical trial.
Secondary ID [1] 306391 0
none
Universal Trial Number (UTN)
Trial acronym
TEOCOOONSDRCCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Increased optic nerve sheath diamether (ONSD) 325218 0
Raised intracranial pressure
 326081 0
Condition category
Condition code
Physical Medicine / Rehabilitation 322621 322621 0 0
Other physical medicine / rehabilitation
Neurological 322863 322863 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 322826 0
Treatment: Other
Intervention code [2] 323394 0
Prevention
Comparator / control treatment
The placebo technique will be applied one week apart to avoid interference.
The placebo technique will be performed with the same placement of the hands as the intervention, but without applying pressure.
Control group
Placebo

Outcomes
Primary outcome [1] 330413 0
"OPTIC NERVE SHEATH DIAMETHER (ONSD)" changes. measure in tenths of a millimeter.
Optic nerve sheath diamether will be measured with an ultrasound device (Siemens, sonoline, adara)
No known adverse effects
The "ONSD" of the right and left eye will be measured.
Two measurements will be taken from each eye.
Timepoint [1] 330413 0
The measures will be taken:
T0: After being 5 minutes lying down at 0 degrees
T1: After 3.5 hours at -12º tilt head down
T2: After applying the technique or the placebo 15 minutes (remaining -12º tilt head down, primary endpoint)
Secondary outcome [1] 407082 0
BLOOD PRESSURE (mmHg)
bLOOD PRESSURE will be measured with an automated blood pressure cuff over the brachial artery (Microlife, Dunedin, FL).
Timepoint [1] 407082 0
The measures will be taken:
T0: After being 5 minutes lying down at 0 degrees
T1: After 3.5 hours at -12º tilt head down
T2: After applying the technique or the placebo 15 minutes (remaining -12º tilt head down.
Secondary outcome [2] 407499 0
HEART RATE will be measured with an automated blood pressure cuff over the brachial artery (Microlife, Dunedin, FL).
Timepoint [2] 407499 0
The measures will be taken:
T0: After being 5 minutes lying down at 0 degrees
T1: After 3.5 hours at -12º tilt head down
T2: After applying the technique or the placebo 15 minutes (remaining -12º tilt head down,
Secondary outcome [3] 407500 0
JUGULAR SECTION changes. measure in tenths of cm2
Ultrasound device (Mindray DP30)
No known adverse effects
Timepoint [3] 407500 0
The mesaures will be taken:
T0: After being 5 minutes lying down at 0 degrees
T1: After 3.5 hours at -12º tilt head down
T2: After applying the technique or the placebo 15 minutes (remaining -12º tilt head down,

Eligibility
Key inclusion criteria
BMI less than 30
Minimum age
20 Years
Maximum age
53 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be done by sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A descriptive analysis will be carried out, expressing the qualitative variables through the absolute and relative frequencies and the quantitative ones through means and standard deviations, if they follow a
normal distribution, or through the medians and the interquartile range, otherwise.
The inferential analysis will be carried out using the ANOVA test. The association between variables will be made through contingency tables when qualitative variables are related by applying the chi-square test. To assess the association between a dichotomous qualitative variable and a numerical one, the Student's T test will be used if the quantitative variable follows a normal distribution (Kolmogorov-Smirnov test) or, otherwise, the Fisher's test will be used. If the qualitative variable is polytomous, we will use the ANOVA test or the Kruskal-Wallis test depending on the normality or not of the quantitative variable. If the significance of the associations allows it (p<0.05) and taking into account the covariates and once dependency has been ruled out, an attempt will be made to create a multivariate model using binary logistic regression techniques. The OR and their 95% Confidence Intervals will be calculated to measure the association between the variables. A significance level of less than 0.05 will be considered, with a confidence level of 95%. The statistical program SPSS v.22 will be used.
Statistical analysis will be done by intention to treat.

The calculation of the sample size has been carried out based on the results of the Marshall-Goebel K 2017 studies with a methodology similar to this one, with the same slope -12º and the same time of 3.5 hours, the intervention in this case was exert lower negative pressure and ours is to exert higher positive pressure. Considering your results the first calculation (with 0.8 mm standard deviation). Accepting an alpha risk of 0.05 and a beta risk of 0.2 in a bilateral contrast, 14 subjects per group are required to detect a difference equal to or greater than 0.9 mm. The common standard deviation is assumed to be 0.8 mm. A rate of loss to follow-up of 10% has been estimated.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
31/05/2022
Actual
31/05/2022
Date of last participant enrolment
Anticipated
26/07/2022
Actual
26/07/2022
Date of last data collection
Anticipated
15/08/2022
Actual
29/08/2022
Sample size
Target
28
Accrual to date
Final
28
Recruitment outside Australia
Country [1] 24563 0
Spain
State/province [1] 24563 0
GALICIA

Funding & Sponsors
Funding source category [1] 310744 0
Self funded/Unfunded
Name [1] 310744 0
ANGEL BURREL BOTAYA
Country [1] 310744 0
Spain
Primary sponsor type
Individual
Name
ANGEL BURREL BOTAYA
Address
CLINICA BURREL MARTINEZ
c/ Sol 197, bajo
15405 -Ferrol- Spain
Country
Spain
Secondary sponsor category [1] 311968 0
Charities/Societies/Foundations
Name [1] 311968 0
NEUROBURGAS
Address [1] 311968 0
NEUROBURGAS
R. Río Xares, 16, 32001 Ourense
SPAIN
Country [1] 311968 0
Spain
Secondary sponsor category [2] 312210 0
Charities/Societies/Foundations
Name [2] 312210 0
UNIVERSIDAD DE SEVILLA
Address [2] 312210 0
C. San Fernando, 4, 41004 Sevilla
Country [2] 312210 0
Spain
Secondary sponsor category [3] 312211 0
Charities/Societies/Foundations
Name [3] 312211 0
ESCUELA DE OSTEOPATIA DE MADRID
Address [3] 312211 0
C/ Saturnino Calleja, 1 28002 – Madrid
Country [3] 312211 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310319 0
COMITÉ DE ÉTICA DE LA INVESTIGACIÓN DE PONTEVEDRA-VIGO-OURENSE
Ethics committee address [1] 310319 0
Agencia Gallega de Conocimiento en Salud
Avda. Fernando de Casas Novoa, nº 37 | Portal A-B | 1º planta
15707 | Santiago de Compostela
SPAIN
Ethics committee country [1] 310319 0
Spain
Date submitted for ethics approval [1] 310319 0
Approval date [1] 310319 0
20/01/2022
Ethics approval number [1] 310319 0
Código de Registro: 2021/317

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117238 0
Prof ANGEL BURREL BOTAYA
Address 117238 0
CLINICA BURREL MARTINEZ
C/ Sol 197 bajo
15405 - Ferrol
Spain
Country 117238 0
Spain
Phone 117238 0
+34659522551
Fax 117238 0
Email 117238 0
a.burrel@escuelaosteopatiamadrid.com
Contact person for public queries
Name 117239 0
Prof ANGEL BURREL BOTAYA
Address 117239 0
CLINICA BURREL MARTINEZ
C/ Sol 197 bajo
15405 - Ferrol
Spain
Country 117239 0
Spain
Phone 117239 0
+34659522551
Fax 117239 0
Email 117239 0
a.burrel@escuelaosteopatiamadrid.com
Contact person for scientific queries
Name 117240 0
Prof ANGEL BURREL BOTAYA
Address 117240 0
CLINICA BURREL MARTINEZ
C/ Sol 197 bajo
15405 - Ferrol
Spain
Country 117240 0
Spain
Phone 117240 0
+34659522551
Fax 117240 0
Email 117240 0
a.burrel@escuelaosteopatiamadrid.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15043Study protocol    383545-(Uploaded-10-02-2022-21-01-08)-Study-related document.pdf
15045Informed consent form    383545-(Uploaded-10-02-2022-21-00-33)-Study-related document.pdf
15046Ethical approval    383545-(Uploaded-10-02-2022-20-59-36)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.