Lumbar Spine AdaptationMattress&SpineNCT04638374
Adaptation of Lumbar Spine to a Mattress: a MRI Evaluation.
An observational study of Lumbar Spine Adaptation, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
People spend almost a third of their life sleeping and understanding how the spine can adapt to a mattress is essential for promoting people's health. The general objective of this study is to study and evaluate the adaptation of the spine to a mattress. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Lumbar Spine Adaptation
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 4 Nov 2020to 31 Oct 2021
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy people between 18 and 45 years of age.
Who may be able to join
- Aged between 18 and 45 years old
- Female or Male sex
- Cognitive integrity
- Absence of usual contraindications to MRI
Who cannot join
- Clinical condition diagnosed by a doctor
- Spinal pathologies
- Pregnant woman
- Claustrophobia
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Istituto Ortopedico Galeazzi
Milan, 20161
Jacopo Antonino Vitale, PhD, 0039 0266214939, jacopo.vitale@grupposandonato.it
About this study
People spend almost a third of their life sleeping and understanding how the spine can adapt to a mattress is essential for promoting people's health. The general objective of this study is to study and evaluate the adaptation of the spine to a mattress. The primary objective is the assessment of the variation in the lumbar lordosis angle (sagittal plane) in the supine position, on a mattress, compared to the value measured in the supine position on a rigid surface.
- Conditions
- Lumbar Spine Adaptation
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of lumbar section of spine in a supine position on a mattress
Magnetic Risonance is used to assess the spine
Measured: 10 minutes
Evaluation of lumbar section of spine in a supine position without mattress
Magnetic Risonance is used to assess the spine
Measured: 10 minutes
Secondary outcomes (1)
Evaluation of lumbar section of spine in a standing position
EOS is used to assess the spine
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start4 Nov 2020
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lumbar Spine AdaptationStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04638374
- Sponsor's protocol ID
- Mattress & Spine
- Acronym
- Mattress&Spine
- Status last verified
- Nov 2020
- First submitted
- 16 Nov 2020
- Last updated
- 30 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vitale JA, Borghi S, Bassani T, Messina C, Sconfienza LM, Galbusera F. Effect of a mattress on lumbar spine alignment in supine position in healthy subjects: an MRI study. Eur Radiol Exp. 2023 Sep 4;7(1):47. doi: 10.1186/s41747-023-00361-w.
PubMed 37661237
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation of Lumbar Spine to a Mattress: a MRI Evaluation.
- ClinicalTrials.gov ID
- NCT04638374
- Acronym / sponsor ID
- Mattress&Spine / Mattress & Spine
- Conditions
- Lumbar Spine Adaptation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 4 Nov 2020 (actual)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 20 Nov 2020 (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.
People spend almost a third of their life sleeping and understanding how the spine can adapt to a mattress is essential for promoting people's health. The general objective of this study is to study and evaluate the adaptation of the spine to a mattress. The primary objective is the assessment of the variation in the lumbar lordosis angle (sagittal plane) in the supine position, on a mattress, compared to the value measured in the supine position on a rigid surface.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy people between 18 and 45 years of age.
Key inclusion criteria (4 listed)
- Aged between 18 and 45 years old
- Female or Male sex
- Cognitive integrity
- Absence of usual contraindications to MRI
Key exclusion criteria (4 listed)
- Clinical condition diagnosed by a doctor
- Spinal pathologies
- Pregnant woman
- Claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of lumbar section of spine in a supine position on a mattress
Time frame: 10 minutes
Magnetic Risonance is used to assess the spine
Evaluation of lumbar section of spine in a supine position without mattress
Time frame: 10 minutes
Magnetic Risonance is used to assess the spine
1 secondary outcome
Evaluation of lumbar section of spine in a standing position
Time frame: 2 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2020.
- Derived from this study: PubMed 37661237Vitale JA, Borghi S, Bassani T, Messina C, Sconfienza LM, Galbusera F. Effect of a mattress on lumbar spine alignment in supine position in healthy subjects: an MRI study. Eur Radiol Exp. 2023 Sep 4;7(1):47. doi: 10.1186/s41747-023-00361-w.
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.
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 Lumbar Spine Adaptation, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 30 Nov 2020. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jacopo A Vitale, PhD (+390266214980, jacopo.vitale@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of lumbar section of spine in a supine position on a mattress (time frame: 10 minutes). The study lists 2 primary outcomes in all. 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 NCT04638374, which also lists 1 linked publication.
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 30 Nov 2020.