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CompletedNCT04901533Updated Nov 10, 2022

Cervical Manipulation (OAA Technique) in Exophories

An interventional study of O-A-A and cranial listening in Exophoria, sponsored by University of Seville. Completed at 1 site in Spain. Open to participants aged 18 Years to 57 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-10.

Sponsored by University of Seville · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years to 57 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Exophoria

Keywords

  • cervical manipulation
  • disorder ocular motility
  • musculoeskeletal
  • strabismus
03

In context

Exotropia

58 studies on the registry are indexed under Exotropia; 13 are open to participants now.

This study's enrollment of 44 is below the median of 50 across 49 interventional studies indexed under Exotropia.

Browse Exotropia studies →

Lead sponsor

University of Seville is the lead sponsor of 130 studies on the registry; 39 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 57 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Clinical diagnosis of exophoria
  • Being 18 years old.

Exclusion criteria

Exclusion Criteria:

  • Having heterotropia or have been treated for it.
  • Present 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
44 participants (actual)

Study arms

  • 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

  • Active comparator
    Cranial Listening

    Cranial palpation maneuver

    Procedure: cranial listening

Interventions

  • ProcedureO-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.

  • Procedurecranial 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Changes from baseline to moment after intervention

  2. 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.

    Time frame: Changes from baseline to moment after intervention

Secondary outcomes

  1. 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.

    Time frame: Changes from baseline to 1 week after intervention

  2. 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.

    Time frame: Changes from baseline to 1 week after intervention

07

Study locations

1 site
  • Lourdes M Fernández-Seguín
    Sevilla, Spain
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04901533
Responsible party
Lourdes Mª Fernández Seguín (Assistant Professor. Physiotherapy Department, University of Seville) — Principal investigator
First posted
May 25, 2021
Start date
May 20, 2021
Primary completion
Jul 1, 2021
Completion
Sep 1, 2021
Last update
Nov 10, 2022

Study contacts

Lourdes M Fernández-Seguín, PhD
principal investigator · University of Seville

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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