Effect of Osteopathic Techiniques on Intraocular Pressure

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

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.

Study Overview

• Status: Completed
• Conditions: Intraocular Pressure; Osteopathic Manipulative Treatment
• Intervention / Treatment: Other: Upper cervical manipulation; Other: Sphenopalatine ganglion manipulation

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Jundiaí, São Paulo, Brazil, 13208-120
      • Escola Superior de Educação Física

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Upper cervical manipulation group; The patient will be in the supine position. The cephalic hand will make contact with one side of the patient's skull, leaving the sternocleidomastoid muscle between the third and fourth fingers. The caudal hand will make global contact with the patient's skull on the opposite side. The therapist should place his torso on the patient's head, leaving the two forearms aligned with the axis of the patient's spine, as this technique is applied to the axis of the odontoid process of the ax. With neutral flexion-extension the therapist will place the rotation parameter to the opposite side (70-80 degrees) and a small contralateral inclination. Then it will search for the driving barrier with a small axial traction movement. When the driving barrier is found, the thrust should be applied in a helical direction, increasing rotation and traction. It will be applied bilaterally.	Other: Upper cervical manipulation; The patient will receive an upper cervical manipulation as described in the Experimental Group 1.
Experimental: Sphenopalatine ganglion group; The patient will be supine on the bench and the therapist with gloves will sit next to the patient contralateral to the manipulated sphenopalatine ganglion (SPG). One of the therapist's hands will be placed flat in contact with the apex of the patient's head to stabilize it. The patient will be instructed to open his mouth and deviate the mandible laterally to the same side of the ganglion to be treated. The therapist will then apply pressure to the SPG with the fifth finger of your other hand in the patient's mouth, moving up along the alveolar process of the maxilla teeth to reach the pterygoid process. The therapist will keep the patient's head elevated until the lateral pterygoid muscle relaxes. Then, the pressure will be applied into the pterygopalatine fossa. The therapist will then apply gentle pressure on the SPG with the pulp of the fifth finger until tissue relaxation. He will then release the contralateral SPG in the same way.	Other: Sphenopalatine ganglion manipulation; The patient will receive a sphenopalatine ganglion as described in the Experimental Group 2.
No Intervention: Control Group; The patient will lie down on the bench for 10 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2021
• Primary Completion (Actual): November 9, 2021
• Study Completion (Actual): November 19, 2021

Study Registration Dates

• First Submitted: April 20, 2021
• First Submitted That Met QC Criteria: April 27, 2021
• First Posted (Actual): April 28, 2021

Study Record Updates

• Last Update Posted (Actual): December 2, 2021
• Last Update Submitted That Met QC Criteria: November 21, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: intraocular pressure; sphenopalatine ganglion; superior cervical ganglion; aqueous humour
• Other Study ID Numbers: RBorges

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No