Preliminary Evaluation of an Osteopathic Manipulative Treatment (OMT) to Prevent Motion Sickness Symptoms

NCT ID: NCT05611814

Last Updated: 2022-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-24

Study Completion Date

2022-09-24

Brief Summary

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Motion sickness directly impacts the readiness of the Army's aviation units. Severe motion sickness results in the dismissal of pilot and air crew candidates during initial training, while minor to moderate symptoms can be distracting during flight. The current medications on the market that target motion sickness symptoms are prohibited for use before flight. Osteopathic Manipulative Techniques are a low to no cost option, which lacks side effects, that allows Doctor of Osteopathic Medicine flight surgeons the opportunity to treat crew members without the use of pharmaceuticals. If effective, these techniques could be used to ensure aircrew readiness. Given the paucity of research on such a technique, a small, pilot study was conducted to demonstrate potential for such an approach.

Detailed Description

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Conditions

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Motion Sickness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Between subjects design with two groups: sham and experimental (osteopathic manipulative treatment \[OMT\])
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Participants received treatment in private room. Study team and participants were blind to group (treatment received). Only the treatment administrator knew which treatment each participant received and was excluded from the remainder of the protocol.

Study Groups

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Sham treatment

The sham maneuver treatment addressed soft tissue tension, restriction of motion, and tenderness of the lower thoracic and lumbar regions.

Group Type SHAM_COMPARATOR

Sham treatment

Intervention Type OTHER

Targeted anatomical structures are Thoracic Paraspinal Muscles, Lumbar Paraspinal Muscles, Lower Trapezius Muscles, Sacrum, Supraspinatus, T5-T12, and Rib 2-12. Techniques include Soft tissue inhibition, Stretching, Kneading, counterstrain, Facilitated Positional Release, and muscle energy technique.

L1-L5

Experimental Osteopathic Manipulative Treatment

The sham maneuver treatment addressed soft tissue tension, restriction of motion, and tenderness of the cervical region (targeted anatomical structures).

Group Type EXPERIMENTAL

Osteopathic Manipulative Treatment

Intervention Type OTHER

Targeted anatomical structures are Scalene Muscles (Anterior/Middle/Posterior), Sternocleidomastoid Muscles (SCM), Suboccipital region, Cervical Paraspinal Muscles, Levator Scapulae Muscles, Upper Thoracic Paraspinal Muscles, Upper Trapezius Muscles, Atlanto-occipital (OA), Atlanto-axial (AA), C2-C7 vertebrae, T1-T4 vertebrae, Rib 1 bilaterally. Techniques include Suboccipital Myofascial Release, Soft tissue inhibition, kneading stretching, Facilitated Positional Release, and muscle energy technique.

Interventions

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Osteopathic Manipulative Treatment

Targeted anatomical structures are Scalene Muscles (Anterior/Middle/Posterior), Sternocleidomastoid Muscles (SCM), Suboccipital region, Cervical Paraspinal Muscles, Levator Scapulae Muscles, Upper Thoracic Paraspinal Muscles, Upper Trapezius Muscles, Atlanto-occipital (OA), Atlanto-axial (AA), C2-C7 vertebrae, T1-T4 vertebrae, Rib 1 bilaterally. Techniques include Suboccipital Myofascial Release, Soft tissue inhibition, kneading stretching, Facilitated Positional Release, and muscle energy technique.

Intervention Type OTHER

Sham treatment

Targeted anatomical structures are Thoracic Paraspinal Muscles, Lumbar Paraspinal Muscles, Lower Trapezius Muscles, Sacrum, Supraspinatus, T5-T12, and Rib 2-12. Techniques include Soft tissue inhibition, Stretching, Kneading, counterstrain, Facilitated Positional Release, and muscle energy technique.

L1-L5

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Must have normal hearing, vision or corrected to normal vision, and cognitive function as determined by self-report and review on demographics and personal history questionnaire.
* Must have obtained at minimum 6 hours of sleep prior to data collection, as assessed by self-report.
* Must have refrained from consumption of alcohol and Medications that impact motion sickness symptoms for a minimum of 16 hours prior to each test session, assessed by self-report.

Exclusion Criteria

1. Must not be currently taking any medications that may affect the vestibular system as assessed by self-report and at the discretion of the study physician.
2. Must not have a history of vestibular disorders as assessed by self-report.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alabama College of Osteopathic Medicine

OTHER

Sponsor Role collaborator

Department of Aviation Medicine, U.S. Army Medical Center of Excellence

UNKNOWN

Sponsor Role collaborator

United States Army Aeromedical Research Laboratory

FED

Sponsor Role lead

Responsible Party

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Amanda Kelley

Research Psychologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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US Army Aeromedical Research Laboratory

Fort Rucker, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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2022-019; M10996

Identifier Type: -

Identifier Source: org_study_id

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