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CompletedNCT05296200Updated Mar 25, 2022

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

An observational study in Intervertebral Disc Herniation and Stiffness; Spine, sponsored by Universidad Autonoma de Madrid. Completed at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-03-25.

Sponsored by Universidad Autonoma de Madrid · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
12
Ages
18 Years to 65 Years
Sex
All
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Study summary

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

Read the detailed description

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.

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Conditions studied

  • Intervertebral Disc Herniation
  • Stiffness; Spine
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In context

Intervertebral Disc Displacement

478 studies on the registry are indexed under Intervertebral Disc Displacement; 104 are open to participants now.

This study's enrollment of 12 is below the median of 100 across 121 observational studies indexed under Intervertebral Disc Displacement.

Browse Intervertebral Disc Displacement studies →

Lead sponsor

Universidad Autonoma de Madrid is the lead sponsor of 48 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

NASA astronaut criteria (1.57-1.90m, 50-95kg)

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • current back/neck pain, musculoskeletal disorder, cardiovascular disease, spine surgery and being, or suspected to be pregnant
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
12 participants (actual)
Patient registry
No

Groups and cohorts

  • Observacional group

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

    Device: Hyperbuoyancy Floatation

Interventions

  • DeviceHyperbuoyancy 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.

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What researchers measure

Primary outcomes

  1. Height

    Standing stature measured by a commercial stadiometer (Seca 217, Germany)

    Time frame: up to 2 years

Secondary outcomes

  1. Height of cervical Intervertebral Discs

    Disc height (C3-T1) measured by ultrasound (Samsung HS40, South Korea)

    Time frame: up to 2 years

  2. Longus Collis and Semispinalis Cervicis thickness and cross-sectional area.

    Neck flexor (Longus Collis) and Neck extensor (Semispinalis Cervicis) were assessed by ultrasound (Samsung HS40, South Korea) and their respective muscle thickness and cross-sectional area was calculated.

    Time frame: up to 2 years

  3. Vertebral Stiffness

    Vertebral stiffness from C0 to L5 was assessed passively (in the prone position) with a handheld differential vertebral compliance transducer (PulStar, Sense Technology Inc., USA) in Newtons.

    Time frame: up to 2 years

  4. Self-reported neck pain

    Pain rating scale (CHAPS) from 0 to 10

    Time frame: up to 2 years

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Study locations

1 site
  • CSEU-Lasalle
    Madrid, 28029, Spain
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References and documents

Publications

  • 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. PubMed 29403389 ↗
  • 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. PubMed 24135505 ↗
  • 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. PubMed 32982803 ↗
  • 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. PubMed 31572205 ↗

Individual participant data

Plan to share: No — Data is going to be shared between the investigators authors.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05296200
Lead sponsor
Universidad Autonoma de Madrid
Collaborators
Centro Superior de Estudios Universitarios Lasalle
Responsible party
David Marcos (Principal Investigador, Universidad Autonoma de Madrid) — Principal investigator
First posted
Mar 25, 2022
Start date
Mar 13, 2020
Primary completion
Jul 25, 2020
Completion
Feb 10, 2022
Last update
Mar 25, 2022

Study contacts

Alfonso Gil Martinez, PhD
study director · Centro Superior de Estudios Universitarios Lasalle

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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