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

Motion Sickness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05611814
• Other study ID #: 2022-019; M10996
• Status: Completed
• Phase: N/A
• Start date: September 24, 2022
• Est. completion date: September 24, 2022

Study information

• Verified date: November 2022
• Source: United States Army Aeromedical Research Laboratory
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 24, 2022
• Est. primary completion date: September 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Motion Sickness

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	US Army Aeromedical Research Laboratory	Fort Rucker	Alabama

Sponsors (3)

Lead Sponsor	Collaborator
United States Army Aeromedical Research Laboratory	Alabama College of Osteopathic Medicine, Department of Aviation Medicine, U.S. Army Medical Center of Excellence

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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)