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

Primary Purpose

Motion Sickness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Osteopathic Manipulative Treatment
Sham treatment
Sponsored by
United States Army Aeromedical Research Laboratory
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Motion Sickness

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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: 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. Must not have a history of vestibular disorders as assessed by self-report.

Sites / Locations

  • US Army Aeromedical Research Laboratory

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Sham treatment

Experimental Osteopathic Manipulative Treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in Motion sickness assessment questionnaire: gastrointestinal subscore from pre- to post-procedure
The Motion Sickness Assessment Questionnaire is a valid and reliable measure of the four dimensions of motion sickness: gastrointestinal, central, peripheral, and sopite-related (Gianaros, et al., 2001). It includes 16 items and response format is a likert scale (1 to 9). The difference in scores from pre- to post-procedure were calculated.
Change in Motion sickness assessment questionnaire: central subscore from pre- to post-procedure
The Motion Sickness Assessment Questionnaire is a valid and reliable measure of the four dimensions of motion sickness: gastrointestinal, central, peripheral, and sopite-related (Gianaros, et al., 2001). It includes 16 items and response format is a likert scale (1 to 9). The difference in scores from pre- to post-procedure were calculated.
Change in Motion sickness assessment questionnaire: peripheral subscore from pre- to post-procedure
The Motion Sickness Assessment Questionnaire is a valid and reliable measure of the four dimensions of motion sickness: gastrointestinal, central, peripheral, and sopite-related (Gianaros, et al., 2001). It includes 16 items and response format is a likert scale (1 to 9). The difference in scores from pre- to post-procedure were calculated.
Change in Motion sickness assessment questionnaire: sopite-related subscore from pre- to post-procedure
The Motion Sickness Assessment Questionnaire is a valid and reliable measure of the four dimensions of motion sickness: gastrointestinal, central, peripheral, and sopite-related (Gianaros, et al., 2001). It includes 16 items and response format is a likert scale (1 to 9). The difference in scores from pre- to post-procedure were calculated.
Change in Motion sickness assessment questionnaire: total subscore from pre- to post-procedure
The Motion Sickness Assessment Questionnaire is a valid and reliable measure of the four dimensions of motion sickness: gastrointestinal, central, peripheral, and sopite-related (Gianaros, et al., 2001). It includes 16 items and response format is a likert scale (1 to 9). The difference in scores from pre- to post-procedure were calculated.
Heart rate variability
Heart rate was aggregated in 30-second intervals. Coefficients of variance were then calculated across the twenty 30-second intervals per participant.

Secondary Outcome Measures

Full Information

First Posted
November 1, 2022
Last Updated
November 7, 2022
Sponsor
United States Army Aeromedical Research Laboratory
Collaborators
Alabama College of Osteopathic Medicine, Department of Aviation Medicine, U.S. Army Medical Center of Excellence
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1. Study Identification

Unique Protocol Identification Number
NCT05611814
Brief Title
Preliminary Evaluation of an Osteopathic Manipulative Treatment (OMT) to Prevent Motion Sickness Symptoms
Official Title
Preliminary Evaluation of an Osteopathic Manipulative Treatment (OMT) to Prevent Motion Sickness Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
September 24, 2022 (Actual)
Primary Completion Date
September 24, 2022 (Actual)
Study Completion Date
September 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
United States Army Aeromedical Research Laboratory
Collaborators
Alabama College of Osteopathic Medicine, Department of Aviation Medicine, U.S. Army Medical Center of Excellence

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Motion Sickness

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Between subjects design with two groups: sham and experimental (osteopathic manipulative treatment [OMT])
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sham treatment
Arm Type
Sham Comparator
Arm Description
The sham maneuver treatment addressed soft tissue tension, restriction of motion, and tenderness of the lower thoracic and lumbar regions.
Arm Title
Experimental Osteopathic Manipulative Treatment
Arm Type
Experimental
Arm Description
The sham maneuver treatment addressed soft tissue tension, restriction of motion, and tenderness of the cervical region (targeted anatomical structures).
Intervention Type
Other
Intervention Name(s)
Osteopathic Manipulative Treatment
Intervention Description
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
Intervention Name(s)
Sham treatment
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Motion sickness assessment questionnaire: gastrointestinal subscore from pre- to post-procedure
Description
The Motion Sickness Assessment Questionnaire is a valid and reliable measure of the four dimensions of motion sickness: gastrointestinal, central, peripheral, and sopite-related (Gianaros, et al., 2001). It includes 16 items and response format is a likert scale (1 to 9). The difference in scores from pre- to post-procedure were calculated.
Time Frame
Administered immediately pre and post-procedure
Title
Change in Motion sickness assessment questionnaire: central subscore from pre- to post-procedure
Description
The Motion Sickness Assessment Questionnaire is a valid and reliable measure of the four dimensions of motion sickness: gastrointestinal, central, peripheral, and sopite-related (Gianaros, et al., 2001). It includes 16 items and response format is a likert scale (1 to 9). The difference in scores from pre- to post-procedure were calculated.
Time Frame
Administered immediately pre and post-procedure
Title
Change in Motion sickness assessment questionnaire: peripheral subscore from pre- to post-procedure
Description
The Motion Sickness Assessment Questionnaire is a valid and reliable measure of the four dimensions of motion sickness: gastrointestinal, central, peripheral, and sopite-related (Gianaros, et al., 2001). It includes 16 items and response format is a likert scale (1 to 9). The difference in scores from pre- to post-procedure were calculated.
Time Frame
Administered immediately pre and post-procedure
Title
Change in Motion sickness assessment questionnaire: sopite-related subscore from pre- to post-procedure
Description
The Motion Sickness Assessment Questionnaire is a valid and reliable measure of the four dimensions of motion sickness: gastrointestinal, central, peripheral, and sopite-related (Gianaros, et al., 2001). It includes 16 items and response format is a likert scale (1 to 9). The difference in scores from pre- to post-procedure were calculated.
Time Frame
Administered immediately pre and post-procedure
Title
Change in Motion sickness assessment questionnaire: total subscore from pre- to post-procedure
Description
The Motion Sickness Assessment Questionnaire is a valid and reliable measure of the four dimensions of motion sickness: gastrointestinal, central, peripheral, and sopite-related (Gianaros, et al., 2001). It includes 16 items and response format is a likert scale (1 to 9). The difference in scores from pre- to post-procedure were calculated.
Time Frame
Administered immediately pre and post-procedure
Title
Heart rate variability
Description
Heart rate was aggregated in 30-second intervals. Coefficients of variance were then calculated across the twenty 30-second intervals per participant.
Time Frame
Measured throughout procedure (10 minutes total)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: 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. Must not have a history of vestibular disorders as assessed by self-report.
Facility Information:
Facility Name
US Army Aeromedical Research Laboratory
City
Fort Rucker
State/Province
Alabama
ZIP/Postal Code
36362
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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