ExophoriaNCT04901533
Cervical Manipulation (OAA Technique) in Exophories
A study testing O-A-A and cranial listening in people with Exophoria, run by University of Seville at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 57 yearsHealthy volunteers can take part
- Conditions the study is for
- Exophoria
- What is being tested?
- O-A-A and cranial listening
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSpain
- Study dates
- 20 May 2021to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 57 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinical diagnosis of exophoria
- Being 18 years old.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Exophoria
- Being tested
- O-A-A, cranial listening
- Keywords
- cervical manipulation, disorder ocular motility, musculoeskeletal, strabismus
- Medical subject headings
- Exotropia, Ocular Motility Disorders, Strabismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
O-A-AProcedure or surgery
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.
cranial listeningProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: O-A-A |
| Cranial Listening | Active comparator | Cranial palpation maneuver Receives: Procedure: cranial listening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Changes from baseline to moment after intervention
Secondary outcomes (2)
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.
Measured: 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.
Measured: Changes from baseline to 1 week after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start20 May 2021
- Primary completion1 Jul 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ExophoriaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lourdes Mª Fernández Seguín, University of Seville
- Investigators
- Lourdes M Fernández-Seguín, PhD, Principal investigator, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04901533
- Sponsor's protocol ID
- EXOFORIAS
- Status last verified
- Nov 2022
- First submitted
- 20 May 2021
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37347984
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Occipito-atlas-axis Manipulation on Oculomotricity in Individuals With Exophories
- ClinicalTrials.gov ID
- NCT04901533
- Acronym / sponsor ID
- EXOFORIAS
- Conditions
- Exophoria
- Keywords
- cervical manipulation, disorder ocular motility, musculoeskeletal, strabismus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 20 May 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 25 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cervical manipulation | Experimental | Procedure: O-A-AThe 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 Listening | Active comparator | Procedure: cranial listeningCranial palpation maneuver |
Who may qualify
- Ages
- 18 to 57 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of exophoria
- Being 18 years old.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| O-A-Apatient 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. | Procedure or surgery | cervical manipulation |
| cranial listeningThe 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. | Procedure or surgery | Cranial Listening |
Primary outcome
exophoria with cover test at 40 cm
Time frame: Changes from baseline to moment after intervention
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
Time frame: Changes from baseline to moment after intervention
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.
2 secondary outcomes
exophoria with cover test at 40 cm (2)
Time frame: Changes from baseline to 1 week after intervention
exophoria with cover test al 4 m (2)
Time frame: Changes from baseline to 1 week after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Derived from this study: PubMed 37347984Fernandez-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.
Related trials for Exophoria
Recruiting
A-eyedrops on Ocular Alignment and Binocular Vision
Exotropia, Exophoria
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lourdes M Fernández-Seguín, PhD principal investigator
University of Seville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing O-A-A and cranial listening in people with Exophoria, run by University of Seville at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
exophoria with cover test at 40 cm (time frame: Changes from baseline to moment after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04901533, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022.