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Completed

NCT Number: NCT05590754

50% Body Weight Reverses Stature, Lumbar Disc Expansion and Vertebral Compliance by Hyper-Buoyancy Floatation.

Study with the aim to see the effect on a space ground analogue , Hyper-Buoyancy Floatation (HBF) on lumbar column and the effect of a supplementary 50% of an axial load.

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Key information

Conditions

Intervertebral Disc Compression Atrophy Back Injuries Muscle Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Injuries Spine Injury Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universidad Autónoma de Madrid, Madrid, Spain

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About this study

the aim of this study was to determine the effect of 15min of 1g reloading following 4h HBF unloading with, and without 30s of seated static 50% BW axial loading upon stature, lumbar Intervertebral Disc height (via ultrasound), vertebral compliance changes, and back pain.

Who can participate

Healthy volunteers accepted: Yes

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

Hyper-buoyancy Floatation (HBF)

Device

Participants remained on a waterbed encased within a wooden frame partially (≈50%) filled with water super-saturated with magnesium sulphate at a temperature between 34-36°C regulated by an ultra-thin underbed heater. Participants remained supine and motionless when lay on the HBF except for temporary passive re-orientation to/and back from the prone position for vertebral compliance assessment

Axial Load after 4h of HBF

Device

Participants from observational sat upright in a chair without back support for 15 min before post testing (1G), whilst experimental group participants performed a 30s seated squat with 50% of their body weight (BW) before returning to the upright seated position.

Primary outcomes

  1. Height

    Time frame: 2 years

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

Secondary outcomes

  1. Intervertebral Disc Height

    Time frame: 2 years

    Disc height (L2-S1) measured by ultrasound

  2. Vertebral Stiffness

    Time frame: 2 years

    Vertebral stiffness from L1 to L5 was assessed passively (in the prone position) with a handheld differential vertebral compliance transducer (PulStar, Sense Technology Inc., USA) in Newtons.

  3. Self-reported back pain

    Time frame: 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
  • King's College London

Registry information

Official study title

Acute 50% Body Weight Static Axial Loading Reverses Stature Increases, Lumbar Disc Expansion and Vertebral Compliance Modulation Induced by 4 Hours of Hyper-buoyancy Floatation

Important dates

Study start
2018
Primary completion
2018
Study completion
2022
First posted
Oct 21, 2022
Registry last updated
Dec 6, 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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