Intervertebral Disc CompressionNCT05590754
50% Body Weight Reverses Stature, Lumbar Disc Expansion and Vertebral Compliance by Hyper-Buoyancy Floatation.
An observational study of Intervertebral Disc Compression and Muscle Atrophy, run by Universidad Autonoma de Madrid at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Intervertebral Disc Compression, Muscle Atrophy, Spine Injury
- What is being tested?
- Hyper-buoyancy Floatation (HBF) and Axial Load after 4h of HBF
- Type of treatment
- Medical device
- How many people
- 16 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 12 Jun 2018to 1 Mar 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
- Healthy volunteers accepted
- 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
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official 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
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.
Read the detailed description
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.
- Being tested
- Hyper-buoyancy Floatation (HBF), Axial Load after 4h of HBF
- Medical subject headings
- Muscular Atrophy, Spinal Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 HBFDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | 8 participants (4 males, 25.5±4.4 years, 63.5±10.6 kg, 163.2±5.6 cm) Receives: Device: Hyper-buoyancy Floatation (HBF); Device: Axial Load after 4h of HBF | |
| Observational Group | 8 participants (3 males, 27.0±2.0 years, 68.4±11.8 kg, 176.5±10.9 cm Receives: Device: Hyper-buoyancy Floatation (HBF); Device: Axial Load after 4h of HBF |
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: 2 years
Secondary outcomes (3)
Intervertebral Disc Height
Disc height (L2-S1) measured by ultrasound
Measured: 2 years
Vertebral Stiffness
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.
Measured: 2 years
Self-reported back pain
Pain rating scale (CHAPS) from 0 to 10
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start12 Jun 2018
- Primary completion1 Jul 2018
- Study completion1 Mar 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 CompressionStudies 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Centro Superior de Estudios Universitarios Lasalle, King's College London
- Responsible party
- Principal investigator, David Marcos, Universidad Autonoma de Madrid
- Investigators
- David Green, PhD, Study director, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05590754
- Sponsor's protocol ID
- HR-18/19-11548
- Status last verified
- Dec 2022
- First submitted
- 18 Oct 2022
- Last updated
- 6 Dec 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
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.
PubMed 32982803Green 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 24135505Chang DG, Healey RM, Snyder AJ, Sayson JV, Macias BR, Coughlin DG, Bailey JF, Parazynski SE, Lotz JC, Hargens AR. Lumbar Spine Paraspinal Muscle and Intervertebral Disc Height Changes in Astronauts After Long-Duration Spaceflight on the International Space Station. Spine (Phila Pa 1976). 2016 Dec 15;41(24):1917-1924. doi: 10.1097/BRS.0000000000001873.
PubMed 27779600
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05590754
- Acronym / sponsor ID
- HR-18/19-11548
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Universidad Autonoma de MadridUniversity, hospital or other
- Collaborators
- Centro Superior de Estudios Universitarios Lasalle, King's College London
- Study start
- 12 Jun 2018 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 21 Oct 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 analogue , Hyper-Buoyancy Floatation (HBF) on lumbar column and the effect of a supplementary 50% of an axial load.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | – | Device: Hyper-buoyancy Floatation (HBF), Device: Axial Load after 4h of HBF8 participants (4 males, 25.5±4.4 years, 63.5±10.6 kg, 163.2±5.6 cm) |
| Observational Group | – | Device: Hyper-buoyancy Floatation (HBF), Device: Axial Load after 4h of HBF8 participants (3 males, 27.0±2.0 years, 68.4±11.8 kg, 176.5±10.9 cm |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- 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 |
|---|---|---|
| Hyper-buoyancy Floatation (HBF)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 | Device | Experimental Group, Observational Group |
| Axial Load after 4h of HBFParticipants 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. | Device | Experimental Group, Observational Group |
Primary outcome
Height
Time frame: 2 years
Standing stature measured by a commercial stadiometer (Seca 217, Germany)
3 secondary outcomes
Intervertebral Disc Height
Time frame: 2 years
Vertebral Stiffness
Time frame: 2 years
Self-reported back pain
Time frame: 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 6 Dec 2022.
- Background: 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 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 27779600Chang DG, Healey RM, Snyder AJ, Sayson JV, Macias BR, Coughlin DG, Bailey JF, Parazynski SE, Lotz JC, Hargens AR. Lumbar Spine Paraspinal Muscle and Intervertebral Disc Height Changes in Astronauts After Long-Duration Spaceflight on the International Space Station. Spine (Phila Pa 1976). 2016 Dec 15;41(24):1917-1924. doi: 10.1097/BRS.0000000000001873.
- 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.
David Green, PhD study director
King's College London
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intervertebral Disc Compression and Muscle Atrophy, run by Universidad Autonoma de Madrid at 2 sites in 2 countries.
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 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain, United Kingdom. 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: 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 NCT05590754, 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 6 Dec 2022.