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

NCT05018390 | Completed

• 1 other identifier: OSTEOM-1
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Osteopathic manipulative treatment; Ocular pursuit

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  immediately after treatment

• Reaction time

  Time elapsed between target displacement initiation and ocular pursuit initiation. Metric: millisecond.

  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.

  immediately after treatment

Secondary Outcomes (2)

• Score on the test of eyeball passive manual mobilization

  immediately before treatment

• Score on the test of eyeball passive manual mobilization

  immediately after treatment

Study Arms (3)

OMT

EXPERIMENTAL

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

Other: Osteopathic manipulative treatment

Sham

SHAM COMPARATOR

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

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.

Interventions

Osteopathic manipulative treatment 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).

OMT

Sham Osteopathic manipulative treatment 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.

Sham

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ecole d'ostéopathie de Paris: lead
• University of Paris 5 - Rene Descartes: collaborator

Study Sites (1)

Ecole d'Osteopathie de Paris

Paris, 75015, France

Location

Related Publications (1)

• 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.

  PMID: 25258540 BACKGROUND

MeSH Terms

Interventions

Manipulation, Osteopathic

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Mohamed Gharmaoui, MD

  Ecole d'Osteopathie de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The practitioner providing the actual OMT or sham Treatment will not be involved in collecting eye movement data. The persons collecting eye movement data will not know the group to which participants will have been assigned.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: August 24, 2021
• Study Start: November 2, 2021
• Primary Completion: November 10, 2022
• Study Completion: December 10, 2022
• Last Updated: January 4, 2023

Record last verified: 2023-01

Locations

FR (1)