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

NCT05611814 | Completed

• 1 other identifier: 2022-019; M10996
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Motion Sickness

Outcome Measures

Primary Outcomes (6)

• 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)

Study Arms (2)

Sham treatment

SHAM COMPARATOR

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

Other: Sham treatment

Experimental Osteopathic Manipulative Treatment

EXPERIMENTAL

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

Osteopathic Manipulative Treatment OTHER

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.

Experimental Osteopathic Manipulative Treatment

Sham treatment OTHER

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

Sham treatment

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

US Army Aeromedical Research Laboratory

Fort Rucker, Alabama, 36362, United States

Location

MeSH Terms

Conditions

Motion Sickness

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Psychologist

Model Details: Between subjects design with two groups: sham and experimental (osteopathic manipulative treatment \[OMT\])

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 10, 2022
• Study Start: September 24, 2022
• Primary Completion: September 24, 2022
• Study Completion: September 24, 2022
• Last Updated: November 10, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)