Adaptation of Lumbar Spine to a Mattress: a MRI Evaluation.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-04

Study Completion Date

2021-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lumbar Spine Adaptation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Aged between 18 and 45 years old
* Female or Male sex
* Cognitive integrity
* Absence of usual contraindications to MRI

Exclusion Criteria

* Clinical condition diagnosed by a doctor
* Spinal pathologies
* Pregnant woman
* Claustrophobia

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

IRCCS Istituto Ortopedico Galeazzi

Milan, , Italy

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Italy

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jacopo A Vitale, PhD

Role: CONTACT

Phone: +390266214980

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jacopo Antonino Vitale, PhD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED

PMID: 37661237 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Mattress & Spine

Identifier Type: -

Identifier Source: org_study_id