Cervical Manipulation (OAA Technique) in Exophories

Effect of Occipito-atlas-axis Manipulation on Oculomotricity in Individuals With Exophories

Objetive: to assess the efficacy of the occipito-atlas-axis cervical manipulation technique to correct ocular divergence in subjects with exophoria.

Design: quantitative, experimental, longitudinal and prospective study.

Subjects: subjects over 18 years of age, with exophorias, without heterotropies and who do not present a contraindication to cervical manipulation.

Methods:Subjects with this ocular mobility dysfunction are going to be evaluated objectively with the Alternate Cover Test. The ocular deviation will be measured at 40 cm and at 4 meters. The individuals who were part of the experimental group underwent the OAA manipulation technique, and to those who were part of the control group a placebo maneuver. Two measurements were taken from this moment, one immediately after the execution of the technique and another one week later.

Study Overview

• Status: Completed
• Conditions: Exophoria
• Intervention / Treatment: Procedure: O-A-A; Procedure: cranial listening

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Sevilla, Spain
    • Lourdes M Fernández-Seguín

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 57 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical diagnosis of exophoria
• Being 18 years old.

Exclusion Criteria:

• Having heterotropia or have been treated for it.
• Present contraindication to manipulation (recent fractures, sprains, or dislocations, local tumor, rheumatic polyarthritis, Down syndrome, vertebrobasilar insufficiency, basilar impression, refusal to be manipulated).
• Having cervical manipulation before two weeks.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cervical manipulation; The objective of this technique is to restore joint mobility between the joints of the occipital, first (atlas) and second cervical vertebra (axis). It is a technique performed in rotation on a vertical axis that passes through the odontoid process of the axis, without placing flexion or extension, and with very slight sidebending; it is done bilaterally.	Procedure: O-A-A; patient is supine, and the therapist stands on the side to be manipulated. The cranial hand of the therapist globally grasps the patient's skull and turns the patient's neck on that same side. The caudal hand is placed on the patient's face. The technique is performed by an impulse in pure rotation on the side that the cervical region is rotated, with a helical movement.
Active Comparator: Cranial Listening; Cranial palpation maneuver	Procedure: cranial listening; The patient is in the supine position, and the therapist sitting at the head of the patient. The therapist places his hands on the head of the patient, the thumbs touch each other, without touching the vault cranial. A perception of the cranial rhythm is carried out passively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
exophoria with cover test at 40 cm	The exophoria will be evaluated in prismatic diopter. Using the cover alternate test, therapist will measure with a prism ruler the diopters that the subject requires to balance eye movement and that the eye does not move from the outside to the inside when looking at an object at 40 cm.	Changes from baseline to moment after intervention
exophoria with cover test al 4 m	The exophoria will be evaluated in prismatic diopter. Using the cover alternate test, therapist will measure with a prism ruler the diopters that the subject requires to balance eye movement and that the eye does not move from the outside to the inside when looking at an object at 4 meters.	Changes from baseline to moment after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
exophoria with cover test at 40 cm (2)	The exophoria will be evaluated in prismatic diopter. Using the cover alternate test, therapist will measure with a prism ruler the diopters that the subject requires to balance eye movement and that the eye does not move from the outside to the inside when looking at an object at 40 cm.	Changes from baseline to 1 week after intervention
exophoria with cover test al 4 m (2)	The exophoria will be evaluated in prismatic diopter. Using the cover alternate test, therapist will measure with a prism ruler the diopters that the subject requires to balance eye movement and that the eye does not move from the outside to the inside when looking at an object at 4 meters.	Changes from baseline to 1 week after intervention

Collaborators and Investigators

• Sponsor: University of Seville
• Investigators: Principal Investigator: Lourdes M Fernández-Seguín, PhD, University of Seville

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2021
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: May 20, 2021
• First Submitted That Met QC Criteria: May 20, 2021
• First Posted (Actual): May 25, 2021

Study Record Updates

• Last Update Posted (Actual): November 10, 2022
• Last Update Submitted That Met QC Criteria: November 5, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: strabismus; cervical manipulation; disorder ocular motility; musculoeskeletal
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Cranial Nerve Diseases; Ocular Motility Disorders; Strabismus; Exotropia
• Other Study ID Numbers: EXOFORIAS

Drug and device information, study documents

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