Impact of Osteopathic Manipulative Treatment on Pursuit Eye Movements in Healthy Human Adults

January 2, 2023 updated by: Ecole d'ostéopathie de Paris

Impact of Osteopathic Manipulative Treatment on External Lateral Ocular Pursuit, Measured in Healthy Human Adults: a Randomized, Double-blind, Controlled Study

The idea that osteopathic manipulative treatments (OMTs) should have an impact on the human visual system is not new. Nevertheless, there is a lack of scientific, objective, and experimental evidence. Our goal is to conduct a randomized, double-blind, controlled study to evaluate the effect of OMT on ocular pursuit. Eye movements will be measured by an infra-red video-based eye tracking system with a high spatial and temporal resolution. OMTs will be similar to regular treatments given by osteopaths in their daily practice. We hypothesize that OMT will improve the quality of ocular pursuit.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Our hypothesis is based on the implication of the fascial system (i.e., connective tissues) in the structural continuity that gives form and function to every tissue and organ. Fascial tissue, on which osteopathic manipulations are acting by restoring its elasticity, is also present in the eye cavity. The connection between fascia might explain how osteopathic manipulations, applied on structures which can be far from the original dysfunctional point, might improve oculomotricity.

Before and after OMT, practitioners will estimate the lateral and medial oculomotor muscles' and the fascia's tissue elasticity with a manual test. They will softly mobilize the eyeballs in medial and lateral directions (the amplitude of these passive mobilizations will always be lower than active eye rotations) and give an elasticity score. Before and after these tests, pursuit eye movements will be recorded by an independent technician. Participants will be asked to track a target that will be displaced horizontally on a computer screen. The target will move 30 times from left to right and 30 times from right to left with a constant speed of 20 degrees of visual angle per second.

The study will involve three independent groups (experimental, sham, test-retest) of healthy participants. We expect that pursuit improvement will be larger in the experimental group than in the two other groups. Moreover, as secondary goals, we will evaluate the correlation between pursuit eye movement data (obtained with a technical device, in a standardized situation) and subjective assessments of oculomotor muscles' elasticity made by the practitioners providing OMTs. We will also examine the possible practitioner effect (two exclusive osteopaths will provide OMTs).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
201

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • Ecole d'Osteopathie de Paris

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult between 18 and 35 years of age
  • Affiliated to the French Social Security scheme
  • Ability to understand and sign the written consent form

Exclusion Criteria:

  • Eye movements that cannot be calibrated correctly and therefore measured by the eye-tracker
  • Visual deficit that prevents from performing the ocular task
  • Pregnancy or breastfeeding
  • Neurologic, psychiatric or epileptic disorder, or any other neuromuscular disorder
  • Medical treatment affecting the central, autonomous or peripheral nervous system, or affecting vigilance and/or attention
  • Skull fracture less than 12 months ago, symptomatic whiplash less than 3 months ago, spinal pain, fever, abdominal or pelvic pain, myopathy, ocular pain, or nystagmus
  • Legal protection
  • Major risk to develop severe corona virus disease illness, or living with people presenting such a risk

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: OMT
Osteopathic manipulative treatment : participants will receive low-amplitude tissue mobilizations on peripheral, vertebral, cranial and/or visceral articular systems.
Other: Osteopathic manipulative treatment
Participants will be positioned on an exam table supine, seated, or decubitus. Osteopathic manipulations will consist in corrective micro-movements applied on synovial joints, on the skull, the teeth and/or visceral structures of the abdomen or the thorax. Local pressures won't exceed a few tens of grams/cm². Practitioners will realize between 15 and 25 technical gestures per participant. Treatment will last 30 minutes (plus or minus 5 minutes) on average. The technical gestures are referenced in the Glossary of Osteopathic Terminology published by the American Association of Colleges of Osteopathic Medicine (2017).
Sham Comparator: Sham
Participants will be applied gestures that look like actual osteopathic manipulations but are not therapeutic.
Other: Sham Osteopathic manipulative treatment
Participants will be positioned on an exam table supine, seated, or decubitus. They will receive 20 gestures that will be standardized and different from actual osteopathic manipulations (but not identifiable as sham manipulations by the participants). The duration of the sham treatment will be the same as the actual treatment.
No Intervention: Test-retest
Participants will undergo the two eye movement measurements, but will not receive any (actual or sham) treatment. 30 minutes will elapse between the two measurements.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Duration of external lateral ocular pursuit
Time Frame: immediately before treatment
Time spent to track a moving target, by generating smooth eye movements (as opposed to ocular saccades) with a velocity close to the target velocity. Metric: millisecond.
immediately before treatment
Mean change from baseline in duration of external lateral ocular pursuit
Time Frame: immediately after treatment
Change from baseline in time spent to track a moving target, by generating smooth eye movements (as opposed to ocular saccades) with a velocity close to the target velocity. Metric: millisecond.
immediately after treatment
Reaction time
Time Frame: immediately before treatment
Time elapsed between target displacement initiation and ocular pursuit initiation. Metric: millisecond.
immediately before treatment
Mean change from baseline in reaction time
Time Frame: immediately after treatment
Mean change from baseline in time elapsed between target displacement initiation and ocular pursuit initiation. Metric: millisecond.
immediately after treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Score on the test of eyeball passive manual mobilization
Time Frame: immediately before treatment
Tissue elasticity of an oculomotor muscle will be assessed using a 3-points scale (1 = no resistance to the mobilization, 3 = strong resistance). Four muscles (two per eyeball) will be assessed. Maximal score = 12 points.
immediately before treatment
Score on the test of eyeball passive manual mobilization
Time Frame: immediately after treatment
Tissue elasticity of an oculomotor muscle will be assessed using a 3-points scale (1 = no resistance to the mobilization, 3 = strong resistance). Four muscles (two per eyeball) will be assessed. Maximal score = 12 points.
immediately after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ecole d'ostéopathie de Paris

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Paris 5 - Rene Descartes

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mohamed Gharmaoui, MD, Ecole d'Osteopathie de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 2, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 10, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 10, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 18, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 4, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OSTEOM-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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