Adaptation of Lumbar Spine to a Mattress: a MRI Evaluation. (Mattress&Spine)

November 25, 2020 updated by: Istituto Ortopedico Galeazzi
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 Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy people between 18 and 45 years of age.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
10 minutes
Evaluation of lumbar section of spine in a supine position without mattress
Time Frame: 10 minutes
Magnetic Risonance is used to assess the spine
10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of lumbar section of spine in a standing position
Time Frame: 2 minutes
EOS is used to assess the spine
2 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Ortopedico Galeazzi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2020

Primary Completion (Anticipated)

August 31, 2021

Study Completion (Anticipated)

October 31, 2021

Study Registration Dates

First Submitted

November 16, 2020

First Submitted That Met QC Criteria

November 16, 2020

First Posted (Actual)

November 20, 2020

Study Record Updates

Last Update Posted (Actual)

November 30, 2020

Last Update Submitted That Met QC Criteria

November 25, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • Mattress & Spine

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lumbar Spine Adaptation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe