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

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

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

Study Overview

• Status: Completed
• Conditions: Intervertebral Disc Herniation; Stiffness; Spine
• Intervention / Treatment: Device: Hyperbuoyancy Floatation

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.

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28029
    • CSEU-Lasalle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observacional group; Subjects must remain to the exposure of gravity (1G) after 4h of hyperbuoyancy floatation(spine unloading)	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height	Standing stature measured by a commercial stadiometer (Seca 217, Germany)	up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height of cervical Intervertebral Discs	Disc height (C3-T1) measured by ultrasound (Samsung HS40, South Korea)	up to 2 years
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.	up to 2 years
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.	up to 2 years
Self-reported neck pain	Pain rating scale (CHAPS) from 0 to 10	up to 2 years

Collaborators and Investigators

• Sponsor: Universidad Autonoma de Madrid
• Collaborators: Centro Superior de Estudios Universitarios Lasalle
• Investigators: Study Director: Alfonso Gil Martinez, PhD, Centro Superior de Estudios Universitarios Lasalle

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2020
• Primary Completion (Actual): July 25, 2020
• Study Completion (Actual): February 10, 2022

Study Registration Dates

• First Submitted: February 23, 2022
• First Submitted That Met QC Criteria: March 24, 2022
• First Posted (Actual): March 25, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2022
• Last Update Submitted That Met QC Criteria: March 24, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement
• Other Study ID Numbers: CSEULS-PI-032/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data is going to be shared between the investigators authors.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No