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

Study Overview
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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.

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

Conditions
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Motion Sickness

Intervention / Treatment
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* Other: Osteopathic Manipulative Treatment
* Other: Sham treatment


Participation Criteria
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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: 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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Between subjects design with two groups: sham and experimental (osteopathic manipulative treatment [OMT])
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Sham treatment<br>The sham maneuver treatment addressed soft tissue tension, restriction of motion, and tenderness of the lower thoracic and lumbar regions. | Other: Sham treatment<br>* 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<br>|
| Experimental: Experimental Osteopathic Manipulative Treatment<br>The sham maneuver treatment addressed soft tissue tension, restriction of motion, and tenderness of the cervical region (targeted anatomical structures). | Other: Osteopathic Manipulative Treatment<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Administered immediately pre and post-procedure | 
| 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. | Administered immediately pre and post-procedure | 
| 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. | Administered immediately pre and post-procedure | 
| 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. | Administered immediately pre and post-procedure | 
| 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. | Administered immediately pre and post-procedure | 
| 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. | Measured throughout procedure (10 minutes total) |