Research with human participants

Overview of medical research in the Netherlands

The effect of body positioning on vertebral rotation in the normal spine, measured in an upright weight-bearing MR-scanner.

Published:
Last updated:

To investigate the effect of different spinal mechanical loading conditions on (pre-existent) rotation in the normal nonscoliotic human spine in vivo.

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Musculoskeletal and connective tissue disorders congenital
Study type
Observational invasive

ID

NL-OMON31751

Source

ToetsingOnline

Brief title

Vertebral rotation in upright MRI

Condition

  • Musculoskeletal and connective tissue disorders congenital

Synonym

adolescent scoliosis without a known cause

Research involving

Human

Sponsors and support

Primary sponsor :
Universitair Medisch Centrum Utrecht
Source(s) of monetary or material Support :
Ministerie van OC&W

Intervention

Keyword :
body position, upright MRI, vertebral rotation

Outcome measures

Primary outcome

Vertebral rotation in the transverse plane.

Secondary outcome

Not applicable

Background summary

Rotational instability and vertebral rotation plays an important role in the
onset and progression of AIS. However, dorsal shear loads lead to an impairment
of rotational stability of the spine in vitro. This dorsal shear load only
occurs in the upright human spine, not in the spines of other vertebrates,
quadrupedal or bipedal alike.

A recent CT-studie has shown that the normal nonscoliotic spine has a
preexistent rotation, corresponding to the most prevalent types of thoracic
idiopathic scoliosis. However, the vertebral rotation in these studies was
measured in subjects in a supine position.

By subjecting the spine to a more axial load, dorsally- or ventrally directed
shear load by altering the scanning position of the subject (supine, standing
upright and quadrupedal position), we can study the effect of these forces on
preexistent vertebral rotation in vivo.

Study objective

To investigate the effect of different spinal mechanical loading conditions on
(pre-existent) rotation in the normal nonscoliotic human spine in vivo.

Study design

Prospective cohort MRI pilot study

Study burden and risks

There are no major risks associated with participation in this study.

Public
Universitair Medisch Centrum Utrecht

Postbus 85500
3508GA Utrecht
Nederland
Scientific
Universitair Medisch Centrum Utrecht

Postbus 85500
3508GA Utrecht
Nederland

Listed location countries

Netherlands

Age

Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

Healthy volunteers aged 18-30 years old

Exclusion criteria

All contra indications for MRI
A history of any spinal disorder, spinal trauma or spinal surgery.

Design

Study type :
Observational invasive
Masking :
Open (masking not used)
Control :
Uncontrolled
Primary purpose :
Basic science

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
30
Type :
Actual

Approved WMO
Date :
Application type :
First submission
Review commission :
METC Universitair Medisch Centrum Utrecht (Utrecht)
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC Universitair Medisch Centrum Utrecht (Utrecht)
Approved WMO
Date :
Application type :
Amendment
Review commission :
METC Universitair Medisch Centrum Utrecht (Utrecht)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
CCMO NL21119.041.07