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CompletedNCT05611814Updated Nov 10, 2022

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

An interventional study of Osteopathic Manipulative Treatment and Sham treatment in Motion Sickness, sponsored by United States Army Aeromedical Research Laboratory. Completed at 1 site in United States. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-10.

Sponsored by United States Army Aeromedical Research Laboratory · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
19 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Motion Sickness

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03

In context

Motion Sickness

50 studies on the registry are indexed under Motion Sickness; 9 are open to participants now.

This study's enrollment of 12 is below the median of 59 across 44 interventional studies indexed under Motion Sickness.

Browse Motion Sickness studies →

Lead sponsor

United States Army Aeromedical Research Laboratory is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
12 participants (actual)

Study arms

  • Sham comparator
    Sham treatment

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

    Other: Sham treatment

  • Experimental
    Experimental Osteopathic Manipulative Treatment

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

    Other: Osteopathic Manipulative Treatment

Interventions

  • OtherOsteopathic 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.

  • OtherSham 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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Administered immediately pre and post-procedure

  2. 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.

    Time frame: Administered immediately pre and post-procedure

  3. 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.

    Time frame: Administered immediately pre and post-procedure

  4. 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.

    Time frame: Administered immediately pre and post-procedure

  5. 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.

    Time frame: Administered immediately pre and post-procedure

  6. 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.

    Time frame: Measured throughout procedure (10 minutes total)

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Study locations

1 site
  • US Army Aeromedical Research Laboratory
    Fort Rucker, Alabama 36362, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2022 to primary completion in Sep 2022, 0 months.

Of 15 interventional studies with no phase under Motion Sickness, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 29. This study's 0 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 1, 2022
First posted
Nov 10, 2022
StartActual
Sep 24, 2022
Primary completionActual
Sep 24, 2022
CompletionActual
Sep 24, 2022
Last update
Nov 10, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05611814
Lead sponsor
United States Army Aeromedical Research Laboratory
Collaborators
Alabama College of Osteopathic Medicine, Department of Aviation Medicine, U.S. Army Medical Center of Excellence
Responsible party
Amanda Kelley (Research Psychologist, United States Army Aeromedical Research Laboratory) — Principal investigator
First posted
Nov 10, 2022
Start date
Sep 24, 2022
Primary completion
Sep 24, 2022
Completion
Sep 24, 2022
Last update
Nov 10, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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