Cervical Manipulation (OAA Technique) in Exophories
Primary Purpose
Exophoria
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
O-A-A
cranial listening
Sponsored by
About this trial
This is an interventional treatment trial for Exophoria focused on measuring cervical manipulation, disorder ocular motility, musculoeskeletal, strabismus
Eligibility Criteria
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.
Sites / Locations
- Lourdes M Fernández-Seguín
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
cervical manipulation
Cranial Listening
Arm Description
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.
Cranial palpation maneuver
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04901533
Brief Title
Cervical Manipulation (OAA Technique) in Exophories
Official Title
Effect of Occipito-atlas-axis Manipulation on Oculomotricity in Individuals With Exophories
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
May 20, 2021 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
September 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Seville
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exophoria
Keywords
cervical manipulation, disorder ocular motility, musculoeskeletal, strabismus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cervical manipulation
Arm Type
Experimental
Arm Description
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.
Arm Title
Cranial Listening
Arm Type
Active Comparator
Arm Description
Cranial palpation maneuver
Intervention Type
Procedure
Intervention Name(s)
O-A-A
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
cranial listening
Intervention Description
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.
Primary Outcome Measure Information:
Title
exophoria with cover test at 40 cm
Description
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.
Time Frame
Changes from baseline to moment after intervention
Title
exophoria with cover test al 4 m
Description
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.
Time Frame
Changes from baseline to moment after intervention
Secondary Outcome Measure Information:
Title
exophoria with cover test at 40 cm (2)
Description
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.
Time Frame
Changes from baseline to 1 week after intervention
Title
exophoria with cover test al 4 m (2)
Description
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.
Time Frame
Changes from baseline to 1 week after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
57 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lourdes M Fernández-Seguín, PhD
Organizational Affiliation
University of Seville
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lourdes M Fernández-Seguín
City
Sevilla
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Cervical Manipulation (OAA Technique) in Exophories
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