HealthyNCT05018390
Impact of Osteopathic Manipulative Treatment on Pursuit Eye Movements in Healthy Human Adults
A study testing Osteopathic manipulative treatment in people with Healthy, run by Ecole d'ostéopathie de Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Osteopathic manipulative treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 201 participants
- Where
- 1 siteFrance
- Study dates
- 2 Nov 2021to 10 Dec 2022
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult between 18 and 35 years of age
- Affiliated to the French Social Security scheme
- Ability to understand and sign the written consent form
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Healthy
- Being tested
- Osteopathic manipulative treatment, Sham Osteopathic manipulative treatment
- Keywords
- Osteopathic manipulative treatment, Ocular pursuit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic manipulative treatmentOther
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 Osteopathic manipulative treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| OMT | Experimental | Osteopathic manipulative treatment : participants will receive low-amplitude tissue mobilizations on peripheral, vertebral, cranial and/or visceral articular systems. Receives: Other: Osteopathic manipulative treatment |
| Sham | Sham comparator | Participants will be applied gestures that look like actual osteopathic manipulations but are not therapeutic. Receives: Other: Sham Osteopathic manipulative treatment |
| Test-retest | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Duration of external lateral ocular pursuit
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.
Measured: immediately before treatment
Mean change from baseline in duration of external lateral ocular pursuit
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.
Measured: immediately after treatment
Reaction time
Time elapsed between target displacement initiation and ocular pursuit initiation. Metric: millisecond.
Measured: immediately before treatment
Mean change from baseline in reaction time
Mean change from baseline in time elapsed between target displacement initiation and ocular pursuit initiation. Metric: millisecond.
Measured: immediately after treatment
Secondary outcomes (2)
Score on the test of eyeball passive manual mobilization
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.
Measured: immediately before treatment
Score on the test of eyeball passive manual mobilization
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.
Measured: immediately after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start2 Nov 2021
- Primary completion10 Nov 2022
- Study completion10 Dec 2022
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 HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ecole d'ostéopathie de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- University of Paris 5 - Rene Descartes
- Responsible party
- Sponsor
- Investigators
- Mohamed Gharmaoui, MD, Principal investigator, Ecole d'Osteopathie de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05018390
- Sponsor's protocol ID
- OSTEOM-1
- Status last verified
- Jan 2023
- First submitted
- 18 Aug 2021
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bordoni B, Zanier E. Clinical and symptomatological reflections: the fascial system. J Multidiscip Healthc. 2014 Sep 18;7:401-11. doi: 10.2147/JMDH.S68308. eCollection 2014.
PubMed 25258540
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Osteopathic Manipulative Treatment on External Lateral Ocular Pursuit, Measured in Healthy Human Adults: a Randomized, Double-blind, Controlled Study
- ClinicalTrials.gov ID
- NCT05018390
- Acronym / sponsor ID
- OSTEOM-1
- Conditions
- Healthy
- Keywords
- Osteopathic manipulative treatment, Ocular pursuit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Ecole d'ostéopathie de ParisUniversity, hospital or other
- Collaborators
- University of Paris 5 - Rene Descartes
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 10 Nov 2022 (actual)
- Study completion
- 10 Dec 2022 (actual)
- First posted
- 24 Aug 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.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OMT | Experimental | Other: Osteopathic manipulative treatmentOsteopathic manipulative treatment : participants will receive low-amplitude tissue mobilizations on peripheral, vertebral, cranial and/or visceral articular systems. |
| Sham | Sham comparator | Other: Sham Osteopathic manipulative treatmentParticipants will be applied gestures that look like actual osteopathic manipulations but are not therapeutic. |
| Test-retest | No intervention | –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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult between 18 and 35 years of age
- Affiliated to the French Social Security scheme
- Ability to understand and sign the written consent form
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Osteopathic manipulative treatmentParticipants 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). | Other | OMT |
| Sham Osteopathic manipulative treatmentParticipants 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. | Other | Sham |
Primary outcome
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.
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.
Reaction time
Time frame: immediately before treatment
Time elapsed between target displacement initiation and ocular pursuit initiation. Metric: millisecond.
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.
2 secondary outcomes
Score on the test of eyeball passive manual mobilization
Time frame: immediately before treatment
Score on the test of eyeball passive manual mobilization
Time frame: immediately after treatment
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 4 Jan 2023.
- Background: PubMed 25258540Bordoni B, Zanier E. Clinical and symptomatological reflections: the fascial system. J Multidiscip Healthc. 2014 Sep 18;7:401-11. doi: 10.2147/JMDH.S68308. eCollection 2014.
- Individual participant dataSharing planned: Undecided
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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.
Mohamed Gharmaoui, MD principal investigator
Ecole d'Osteopathie de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic manipulative treatment in people with Healthy, run by Ecole d'ostéopathie de Paris at 1 site in France.
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 3 inclusion and 8 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 4 Jan 2023. 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 France. 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. Some participants in this study may receive a placebo. 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?
Duration of external lateral ocular pursuit (time frame: immediately before treatment). The study lists 4 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 NCT05018390, 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 4 Jan 2023; AzTrials last refreshed its copy on 8 Nov 2026.