Effect of Osteopathic Techiniques on Intraocular Pressure
1 other identifier
interventional
7
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2021
CompletedFirst Posted
Study publicly available on registry
April 28, 2021
CompletedStudy Start
First participant enrolled
September 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 9, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 19, 2021
CompletedDecember 2, 2021
November 1, 2021
1 month
April 20, 2021
November 21, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (3)
Upper cervical manipulation group
EXPERIMENTALThe 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.
Sphenopalatine ganglion group
EXPERIMENTALThe 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.
Control Group
NO INTERVENTIONThe patient will lie down on the bench for 10 minutes.
Interventions
The patient will receive an upper cervical manipulation as described in the Experimental Group 1.
The patient will receive a sphenopalatine ganglion as described in the Experimental Group 2.
Eligibility Criteria
You may qualify if:
- Intraocular pressure below 21mmHg
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Escola Superior de Educação Física
Jundiaí, São Paulo, 13208-120, Brazil
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- DO
Study Record Dates
First Submitted
April 20, 2021
First Posted
April 28, 2021
Study Start
September 28, 2021
Primary Completion
November 9, 2021
Study Completion
November 19, 2021
Last Updated
December 2, 2021
Record last verified: 2021-11