Effect of Osteopathic Techiniques on Intraocular Pressure

NCT ID: NCT04863209

Last Updated: 2021-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-28
• Study Completion Date: 2021-11-19

Brief 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.

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.

Conditions

Intraocular Pressure; Osteopathic Manipulative Treatment

Keywords

intraocular pressure; sphenopalatine ganglion; superior cervical ganglion; aqueous humour

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Upper cervical manipulation

Intervention Type: OTHER

The patient will receive an upper cervical manipulation as described in the Experimental Group 1.

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.

Group Type: EXPERIMENTAL

Sphenopalatine ganglion manipulation

Intervention Type: OTHER

The patient will receive a sphenopalatine ganglion as described in the Experimental Group 2.

Control Group

The patient will lie down on the bench for 10 minutes.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Upper cervical manipulation

The patient will receive an upper cervical manipulation as described in the Experimental Group 1.

Intervention Type: OTHER

Sphenopalatine ganglion manipulation

The patient will receive a sphenopalatine ganglion as described in the Experimental Group 2.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Rodolfo Amoroso Borges

DO

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Escola Superior de Educação Física

Jundiaí, São Paulo, Brazil

Countries

Brazil

Other Identifiers

RBorges

Identifier Type: -

Identifier Source: org_study_id