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Completed

NCT Number: NCT05296200

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

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

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Key information

Conditions

Intervertebral Disc Herniation Bone Diseases Hernia Intervertebral Disc Displacement Musculoskeletal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Spinal Diseases Stiffness; Spine

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CSEU-Lasalle

Madrid, 28029, Spain

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hyperbuoyancy Floatation

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.

Primary outcomes

  1. Height

    Time frame: up to 2 years

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

Secondary outcomes

  1. Height of cervical Intervertebral Discs

    Time frame: up to 2 years

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

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

    Time frame: up to 2 years

    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.

  3. Vertebral Stiffness

    Time frame: up to 2 years

    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.

  4. Self-reported neck pain

    Time frame: up to 2 years

    Pain rating scale (CHAPS) from 0 to 10

Sponsors and collaborators

Lead sponsor

Universidad Autonoma de Madrid

Other

Collaborators

  • Centro Superior de Estudios Universitarios Lasalle

Registry information

Official study title

Cervical Intervertebral Disc Expansion, Vertebral Compliance Reduction and Neck Pain is Induced by 4h of Hyper-buoyancy Flotation That is Only Partially Reversed by 15 Mins 1g Re-loading

Important dates

Study start
2020
Primary completion
2020
Study completion
2022
First posted
Mar 25, 2022
Registry last updated
Mar 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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