Effect of Osteopathic Techiniques on Intraocular Pressure

Intraocular Pressure Clinical Trial

Official title:

Effect of Osteopathic Techiniques on Intraocular Pressure: a Randomized Double-blind Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04863209
• Other study ID #: RBorges
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Intraocular Pressure
• Osteopathic Manipulative Treatment

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