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

NCT ID: NCT05018390

Last Updated: 2023-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 201 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-02
• Study Completion Date: 2022-12-10

Brief 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. 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).

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

OMT

Osteopathic manipulative treatment : participants will receive low-amplitude tissue mobilizations on peripheral, vertebral, cranial and/or visceral articular systems.

Group Type: EXPERIMENTAL

Osteopathic manipulative treatment

Intervention Type: OTHER

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

Participants will be applied gestures that look like actual osteopathic manipulations but are not therapeutic.

Group Type: SHAM_COMPARATOR

Sham Osteopathic manipulative treatment

Intervention Type: OTHER

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Paris 5 - Rene Descartes

OTHER

Sponsor Role: collaborator

Ecole d'ostéopathie de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mohamed Gharmaoui, MD

Role: PRINCIPAL_INVESTIGATOR

Ecole d'Osteopathie de Paris

Locations

Ecole d'Osteopathie de Paris

Paris, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 25258540 (View on PubMed)

Other Identifiers

OSTEOM-1

Identifier Type: -

Identifier Source: org_study_id