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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04638374
Recruitment Status : Recruiting
First Posted : November 20, 2020
Last Update Posted : November 30, 2020
Sponsor:
Information provided by (Responsible Party):
Istituto Ortopedico Galeazzi

Study Description
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Brief 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. 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.

Condition or disease
Lumbar Spine Adaptation

Study Design
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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Adaptation of Lumbar Spine to a Mattress: a MRI Evaluation.
Actual Study Start Date : November 4, 2020
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : October 31, 2021
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. Evaluation of lumbar section of spine in a supine position without mattress [ Time Frame: 10 minutes ]
    Magnetic Risonance is used to assess the spine


Secondary Outcome Measures :
  1. Evaluation of lumbar section of spine in a standing position [ Time Frame: 2 minutes ]
    EOS is used to assess the spine


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy people between 18 and 45 years of age.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04638374


Contacts
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Contact: Jacopo A Vitale, PhD +390266214980 jacopo.vitale@grupposandonato.it

Locations
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Italy
IRCCS Istituto Ortopedico Galeazzi Recruiting
Milan, Italy, 20161
Contact: Jacopo Antonino Vitale, PhD    0039 0266214939    jacopo.vitale@grupposandonato.it   
Sponsors and Collaborators
Istituto Ortopedico Galeazzi
More Information
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Responsible Party: Istituto Ortopedico Galeazzi
ClinicalTrials.gov Identifier: NCT04638374    
Other Study ID Numbers: Mattress & Spine
First Posted: November 20, 2020    Key Record Dates
Last Update Posted: November 30, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No