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

Completed

• Conditions: Intervertebral Disc Herniation; Stiffness; Spine
• Interventions: Device: Hyperbuoyancy Floatation

• Registration Number: NCT05296200
• Lead Sponsor: Universidad Autonoma de Madrid

Brief Summary

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

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 Timeline

• Study Start: 2020-03-13
• Primary Completion: 2020-07-25
• Study Completion: 2022-02-10
• Study First Submitted: 2022-02-23
• Status Verified: 2022-03
• Study First Submitted QC: 2022-03-24
• Last Update Submitted: 2022-03-24
• Study First Posted: 2022-03-25
• Last Update Posted: 2022-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observacional group	Hyperbuoyancy Floatation	Subjects must remain to the exposure of gravity (1G) after 4h of hyperbuoyancy floatation(spine unloading)

Primary Outcome Measures

Name	Time	Method
Height	up to 2 years	Standing stature measured by a commercial stadiometer (Seca 217, Germany)

Secondary Outcome Measures

Name	Time	Method
Self-reported neck pain	up to 2 years	Pain rating scale (CHAPS) from 0 to 10
Height of cervical Intervertebral Discs	up to 2 years	Disc height (C3-T1) measured by ultrasound (Samsung HS40, South Korea)
Longus Collis and Semispinalis Cervicis thickness and cross-sectional area.	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.
Vertebral Stiffness	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.

Trial Locations

Locations (1)

CSEU-Lasalle; 🇪🇸 Madrid, Spain