NCT04901533

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

May 20, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 25, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

November 10, 2022

Status Verified

November 1, 2022

Enrollment Period

1 month

First QC Date

May 20, 2021

Last Update Submit

November 5, 2022

Conditions

Keywords

cervical manipulationdisorder ocular motilitymusculoeskeletalstrabismus

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • exophoria with cover test at 40 cm (2)

    Changes from baseline to 1 week after intervention

  • exophoria with cover test al 4 m (2)

    Changes from baseline to 1 week after intervention

Study Arms (2)

cervical manipulation

EXPERIMENTAL

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

Cranial Listening

ACTIVE COMPARATOR

Cranial palpation maneuver

Procedure: cranial listening

Interventions

O-A-APROCEDURE

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.

cervical manipulation

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.

Cranial Listening

Eligibility Criteria

Age18 Years - 57 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical diagnosis of exophoria
  • Being 18 years old.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lourdes M Fernández-Seguín

Seville, Spain

Location

Related Publications (1)

  • Fernandez-Seguin LM, Peinado-Asensio M, Diaz-Mancha JA, Cortes-Vega MD, Heredia-Rizo AM. Short-Term Effect of Spinal Manipulation on the Magnitude of Exophoria in Adults Who Are Asymptomatic: A Randomized Controlled Trial. Phys Ther. 2023 Aug 1;103(8):pzad069. doi: 10.1093/ptj/pzad069.

MeSH Terms

Conditions

ExotropiaOcular Motility DisordersStrabismus

Condition Hierarchy (Ancestors)

Cranial Nerve DiseasesNervous System DiseasesEye DiseasesCentral Nervous System Diseases

Study Officials

  • Lourdes M Fernández-Seguín, PhD

    University of Seville

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor. Physiotherapy Department

Study Record Dates

First Submitted

May 20, 2021

First Posted

May 25, 2021

Study Start

May 20, 2021

Primary Completion

July 1, 2021

Study Completion

September 1, 2021

Last Updated

November 10, 2022

Record last verified: 2022-11

Locations