Motion SicknessNCT05611814
Preliminary Evaluation of an Osteopathic Manipulative Treatment (OMT) to Prevent Motion Sickness Symptoms
A study testing Osteopathic Manipulative Treatment in people with Motion Sickness, run by United States Army Aeromedical Research Laboratory at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Motion Sickness
- What is being tested?
- Osteopathic Manipulative Treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Sep 2022to 24 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
US Army Aeromedical Research Laboratory
Fort Rucker, Alabama, 36362
About this study
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
- Being tested
- Osteopathic Manipulative Treatment, Sham treatment
- Medical subject headings
- Motion Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manipulative TreatmentOther
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 treatmentOther
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
| Study group | Role | What they receive |
|---|---|---|
| Sham treatment | Sham comparator | The sham maneuver treatment addressed soft tissue tension, restriction of motion, and tenderness of the lower thoracic and lumbar regions. Receives: 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). Receives: Other: Osteopathic Manipulative Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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: Measured throughout procedure (10 minutes total)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start24 Sep 2022
- Primary completion24 Sep 2022
- Study completion24 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motion SicknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Between subjects design with two groups: sham and experimental (osteopathic manipulative treatment \[OMT\])
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Army Aeromedical Research Laboratory
- Sponsor type
- US federal agency
- Collaborators
- Alabama College of Osteopathic Medicine, Department of Aviation Medicine, U.S. Army Medical Center of Excellence
- Responsible party
- Principal investigator, Amanda Kelley, United States Army Aeromedical Research Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611814
- Sponsor's protocol ID
- 2022-019; M10996
- Status last verified
- Nov 2022
- First submitted
- 1 Nov 2022
- Last updated
- 10 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Evaluation of an Osteopathic Manipulative Treatment (OMT) to Prevent Motion Sickness Symptoms
- ClinicalTrials.gov ID
- NCT05611814
- Acronym / sponsor ID
- 2022-019; M10996
- Conditions
- Motion Sickness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- United States Army Aeromedical Research LaboratoryUS federal agency
- Collaborators
- Alabama College of Osteopathic Medicine, Department of Aviation Medicine, U.S. Army Medical Center of Excellence
- Study start
- 24 Sep 2022 (actual)
- Primary completion
- 24 Sep 2022 (actual)
- Study completion
- 24 Sep 2022 (actual)
- First posted
- 10 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Between subjects design with two groups: sham and experimental (osteopathic manipulative treatment [OMT])
| Arm | Type | Receives |
|---|---|---|
| Sham treatment | Sham comparator | Other: Sham treatmentThe sham maneuver treatment addressed soft tissue tension, restriction of motion, and tenderness of the lower thoracic and lumbar regions. |
| Experimental Osteopathic Manipulative Treatment | Experimental | Other: Osteopathic Manipulative TreatmentThe sham maneuver treatment addressed soft tissue tension, restriction of motion, and tenderness of the cervical region (targeted anatomical structures). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic Manipulative TreatmentTargeted 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. | Other | Experimental Osteopathic Manipulative Treatment |
| Sham treatmentTargeted 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 | Other | Sham treatment |
Primary outcome
Change in Motion sickness assessment questionnaire: gastrointestinal subscore from pre- to post-procedure
Time frame: Administered immediately pre and 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.
Change in Motion sickness assessment questionnaire: central subscore from pre- to post-procedure
Time frame: Administered immediately pre and 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.
Change in Motion sickness assessment questionnaire: peripheral subscore from pre- to post-procedure
Time frame: Administered immediately pre and 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.
Change in Motion sickness assessment questionnaire: sopite-related subscore from pre- to post-procedure
Time frame: Administered immediately pre and 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.
Change in Motion sickness assessment questionnaire: total subscore from pre- to post-procedure
Time frame: Administered immediately pre and 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.
Heart rate variability
Time frame: Measured throughout procedure (10 minutes total)
Heart rate was aggregated in 30-second intervals. Coefficients of variance were then calculated across the twenty 30-second intervals per participant.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Manipulative Treatment in people with Motion Sickness, run by United States Army Aeromedical Research Laboratory at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Motion sickness assessment questionnaire: gastrointestinal subscore from pre- to post-procedure (time frame: Administered immediately pre and post-procedure). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2022.