Cervical Changes by 4h of Hyper-buoyancy Flotation and Followed by 15 Mins 1g Re-loading

NCT ID: NCT05296200

Last Updated: 2022-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-13

Study Completion Date

2022-02-10

Brief Summary

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Study with the aim to see the effect on a space ground anaologue, Hyperbuoyancy Floatation (HBF) on cervical column.

Detailed Description

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the aim of the study is to determine the effect of 4h HBF and subsequent passive 1g axial loading upon stature, cervical IVD height) cervical muscle (Longus Collis and Semispinalis Cervicis) thickness and CSA assessed with ultrasound, cervical vertebral compliance, their relationships to induced stature increments and neck pain.

Conditions

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Intervertebral Disc Herniation Stiffness; Spine

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Observacional group

Subjects must remain to the exposure of gravity (1G) after 4h of hyperbuoyancy floatation(spine unloading)

Hyperbuoyancy Floatation

Intervention Type DEVICE

Subjects are laid supine upon a HBF waterbed encased within a wooden frame partially (50%) filled with water (at 36ºC to maintain thermal comfort) super-saturated with magnesium sulphate. Thus, subjects are buoyant, sinking passively into the bed in proportion to their segmental mass.

Interventions

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Hyperbuoyancy Floatation

Subjects are laid supine upon a HBF waterbed encased within a wooden frame partially (50%) filled with water (at 36ºC to maintain thermal comfort) super-saturated with magnesium sulphate. Thus, subjects are buoyant, sinking passively into the bed in proportion to their segmental mass.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* physical requirements (1.57-1.90m, 50-95kg)

Exclusion Criteria

* current back/neck pain, musculoskeletal disorder, cardiovascular disease, spine surgery and being, or suspected to be pregnant
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centro Superior de Estudios Universitarios Lasalle

UNKNOWN

Sponsor Role collaborator

Universidad Autonoma de Madrid

OTHER

Sponsor Role lead

Responsible Party

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David Marcos

Principal Investigador

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alfonso Gil Martinez, PhD

Role: STUDY_DIRECTOR

Centro Superior de Estudios Universitarios Lasalle

Locations

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CSEU-Lasalle

Madrid, , Spain

Site Status

Countries

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Spain

References

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Green DA, Scott JPR. Spinal Health during Unloading and Reloading Associated with Spaceflight. Front Physiol. 2018 Jan 18;8:1126. doi: 10.3389/fphys.2017.01126. eCollection 2017.

Reference Type BACKGROUND
PMID: 29403389 (View on PubMed)

Marshburn TH, Hadfield CA, Sargsyan AE, Garcia K, Ebert D, Dulchavsky SA. New heights in ultrasound: first report of spinal ultrasound from the international space station. J Emerg Med. 2014 Jan;46(1):61-70. doi: 10.1016/j.jemermed.2013.08.001. Epub 2013 Oct 15.

Reference Type RESULT
PMID: 24135505 (View on PubMed)

Swanenburg J, Langenfeld A, Easthope CA, Meier ML, Ullrich O, Schweinhardt P. Microgravity and Hypergravity Induced by Parabolic Flight Differently Affect Lumbar Spinal Stiffness. Front Physiol. 2020 Sep 2;11:562557. doi: 10.3389/fphys.2020.562557. eCollection 2020.

Reference Type RESULT
PMID: 32982803 (View on PubMed)

McNamara KP, Greene KA, Tooze JA, Dang J, Khattab K, Lenchik L, Weaver AA. Neck Muscle Changes Following Long-Duration Spaceflight. Front Physiol. 2019 Sep 13;10:1115. doi: 10.3389/fphys.2019.01115. eCollection 2019.

Reference Type RESULT
PMID: 31572205 (View on PubMed)

Other Identifiers

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CSEULS-PI-032/2020

Identifier Type: -

Identifier Source: org_study_id

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