Intervertebral Disc HerniationNCT05296200
Cervical Changes by 4h of Hyper-buoyancy Flotation and Followed by 15 Mins 1g Re-loading
An observational study of Intervertebral Disc Herniation and Stiffness; Spine, run by Universidad Autonoma de Madrid at 1 site in Spain.
Trial summary
Study with the aim to see the effect on a space ground anaologue, Hyperbuoyancy Floatation (HBF) on cervical column. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Intervertebral Disc Herniation, Stiffness; Spine
- What is being tested?
- Hyperbuoyancy Floatation
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- 1 siteSpain
- Study dates
- 13 Mar 2020to 10 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: NASA astronaut criteria (1.57-1.90m, 50-95kg)
Who may be able to join
- physical requirements (1.57-1.90m, 50-95kg)
Who cannot join
- current back/neck pain, musculoskeletal disorder, cardiovascular disease, spine surgery and being, or suspected to be pregnant
Trial locations and contacts
1 site in 1 country.
About this study
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
Study with the aim to see the effect on a space ground anaologue, Hyperbuoyancy Floatation (HBF) on cervical column.
Read the 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.
- Conditions
- Intervertebral Disc Herniation, Stiffness; Spine
- Being tested
- Hyperbuoyancy Floatation
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperbuoyancy FloatationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Observacional group | Subjects must remain to the exposure of gravity (1G) after 4h of hyperbuoyancy floatation(spine unloading) Receives: Device: Hyperbuoyancy Floatation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Height
Standing stature measured by a commercial stadiometer (Seca 217, Germany)
Measured: up to 2 years
Secondary outcomes (4)
Height of cervical Intervertebral Discs
Disc height (C3-T1) measured by ultrasound (Samsung HS40, South Korea)
Measured: 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.
Measured: 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.
Measured: up to 2 years
Self-reported neck pain
Pain rating scale (CHAPS) from 0 to 10
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start13 Mar 2020
- Primary completion25 Jul 2020
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Intervertebral Disc HerniationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Superior de Estudios Universitarios Lasalle
- Responsible party
- Principal investigator, David Marcos, Universidad Autonoma de Madrid
- Investigators
- Alfonso Gil Martinez, PhD, Study director, Centro Superior de Estudios Universitarios Lasalle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05296200
- Sponsor's protocol ID
- CSEULS-PI-032/2020
- Status last verified
- Mar 2022
- First submitted
- 23 Feb 2022
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is going to be shared between the investigators authors.
Publications
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.
PubMed 29403389Marshburn 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.
PubMed 24135505Swanenburg 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.
PubMed 32982803McNamara 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.
PubMed 31572205
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05296200
- Acronym / sponsor ID
- CSEULS-PI-032/2020
- Conditions
- Intervertebral Disc Herniation, Stiffness; Spine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Universidad Autonoma de MadridUniversity, hospital or other
- Collaborators
- Centro Superior de Estudios Universitarios Lasalle
- Study start
- 13 Mar 2020 (actual)
- Primary completion
- 25 Jul 2020 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 25 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observacional group | – | Device: Hyperbuoyancy FloatationSubjects must remain to the exposure of gravity (1G) after 4h of hyperbuoyancy floatation(spine unloading) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- NASA astronaut criteria (1.57-1.90m, 50-95kg)
Key inclusion criteria (1 listed)
- physical requirements (1.57-1.90m, 50-95kg)
Key exclusion criteria (1 listed)
- current back/neck pain, musculoskeletal disorder, cardiovascular disease, spine surgery and being, or suspected to be pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperbuoyancy FloatationSubjects 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. | Device | Observacional group |
Primary outcome
Height
Time frame: up to 2 years
Standing stature measured by a commercial stadiometer (Seca 217, Germany)
4 secondary outcomes
Height of cervical Intervertebral Discs
Time frame: up to 2 years
Longus Collis and Semispinalis Cervicis thickness and cross-sectional area.
Time frame: up to 2 years
Vertebral Stiffness
Time frame: up to 2 years
Self-reported neck pain
Time frame: up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
- Background: PubMed 29403389Green 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.
- Results publication: PubMed 24135505Marshburn 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.
- Results publication: PubMed 32982803Swanenburg 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.
- Results publication: PubMed 31572205McNamara 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.
- Individual participant dataSharing planned: No. Data is going to be shared between the investigators authors.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alfonso Gil Martinez, PhD study director
Centro Superior de Estudios Universitarios Lasalle
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intervertebral Disc Herniation and Stiffness; Spine, run by Universidad Autonoma de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Height (time frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05296200, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2022.