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

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.

Study Overview

• Status: Completed
• Conditions: Motion Sickness
• Intervention / Treatment: Other: Sham treatment; Other: Osteopathic Manipulative Treatment

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Fort Rucker, Alabama, United States, 36362
      • US Army Aeromedical Research Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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: 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; 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: United States Army Aeromedical Research Laboratory
• Collaborators: Alabama College of Osteopathic Medicine; Department of Aviation Medicine, U.S. Army Medical Center of Excellence

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2022
• Primary Completion (Actual): September 24, 2022
• Study Completion (Actual): September 24, 2022

Study Registration Dates

• First Submitted: November 1, 2022
• First Submitted That Met QC Criteria: November 7, 2022
• First Posted (Actual): November 10, 2022

Study Record Updates

• Last Update Posted (Actual): November 10, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Motion Sickness
• Other Study ID Numbers: 2022-019; M10996

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No