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

Intervertebral Disc Herniation Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05296200
• Other study ID #: CSEULS-PI-032/2020
• Status: Completed
• Start date: March 13, 2020
• Est. completion date: February 10, 2022

Study information

• Verified date: March 2022
• Source: Universidad Autonoma de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 10, 2022
• Est. primary completion date: July 25, 2020
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Intervertebral Disc Herniation
• Stiffness; Spine

Intervention

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.

Locations

Country	Name	City	State
Spain	CSEU-Lasalle	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Autonoma de Madrid	Centro Superior de Estudios Universitarios Lasalle

Country where clinical trial is conducted

Spain, 

References & Publications (4)

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. Review. — View Citation

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 — View Citation

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. — View Citation

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. eColle — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Height	Standing stature measured by a commercial stadiometer (Seca 217, Germany)	up to 2 years
Secondary	Height of cervical Intervertebral Discs	Disc height (C3-T1) measured by ultrasound (Samsung HS40, South Korea)	up to 2 years
Secondary	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
Secondary	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
Secondary	Self-reported neck pain	Pain rating scale (CHAPS) from 0 to 10	up to 2 years