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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04863209
Other study ID # RBorges
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 28, 2021
Est. completion date November 19, 2021

Study information

Verified date November 2021
Source Federal University of São Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the effects osteopathic techniques at the upper cervical vertebrae or at the sphenopalatine ganglia on the intraocular pressure.


Description:

The 7 volunteers will be randomized into 3 groups and there will be an experimental group 1 that will receive a technique of manipulation of the upper cervical, an experimental group 2 that will receive a technique of manipulation of the sphenopalatine ganglion and a control group that will not receive any intervention. Each volunteer will participate in the 3 groups. There will be 4 assessments, one before the procedure and one just after each procedure, including the control.


Recruitment information / eligibility

Status Completed
Enrollment 7
Est. completion date November 19, 2021
Est. primary completion date November 9, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Intraocular pressure below 21mmHg Exclusion Criteria: - Positive Klein test - Use of medications that affect the circulatory system in up to one month before the procedures; - Caffeine use 24 hours before procedures; - Presence of ophthalmic diseases; - History of hypertension or diabetes; - Blindness; - Tumor in the head; - Skull or cervical fractures that occurred less than 6 months ago.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Upper cervical manipulation
The patient will receive an upper cervical manipulation as described in the Experimental Group 1.
Sphenopalatine ganglion manipulation
The patient will receive a sphenopalatine ganglion as described in the Experimental Group 2.

Locations

Country Name City State
Brazil Escola Superior de Educação Física Jundiaí São Paulo

Sponsors (1)

Lead Sponsor Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of the intraocular pressure after upper cervical manipulation After this manipulation, it is expected that there will be a sympathetic response increasing the intraocular pressure. Immediately after the intervention and 30 minutes after the intervention
Primary Change of the intraocular pressure after sphenopalatine ganglion manipulation After this manipulation, it is expected that there will be a parasympathetic response decreasing the intraocular pressure. Immediately after the intervention and 30 minutes after the intervention
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