Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04421898 |
| Other study ID # |
RECHMPL20_0303 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2020 |
| Est. completion date |
December 30, 2023 |
Study information
| Verified date |
June 2020 |
| Source |
University Hospital, Montpellier |
| Contact |
Guillaume CAPTIER, MD.PhD |
| Phone |
4 67 33 95 81 |
| Email |
g-captier[@]chu-montpellier.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The congenital muscular torticollis (CMT) is defined by an abnormal posture of the head and
the neck compared to shoulders' level of the newborn. The mainly affected muscle is the
sternocleidomastoid muscle (SCM) causing a lateral inclination of the head on the side
affected by the CMT and a rotation on the opposite side. CMT comes with
asymmetricalndeformation of the skull or plagiocephaly, facial asymmetry, skull and
cranio-vertebral deformatioes in CMT are the results of a complex mechanism of biomechanical
stresses upon a developing skull. The hypothesis of a traction force on the base of the skull
from the SCM could explain most of all the asymmetrical deformatios encountered in CMT. It
would be associated to a compression force at the occipital level
Description:
The congenital muscular torticollis (CMT) is defined by an abnormal posture of the head and
the neck compared to shoulders' level of the newborn. The mainly affected muscle is the
sternocleidomastoid muscle (SCM) causing a lateral inclination of the head on the side
affected by the CMT and a rotation on the opposite side. It is the third cause of neonatal
deformation and affect nearly one newborn out of six, most of the time transiently.
Three types of CMT exist : CMT secondary to a tonus disorder (postural torticollis), CMT
presenting a tumor on the SCM and CMT caused by a retraction and fibrosis of the SCM.
The exact aetiology of CMT is not well known. However, per partum intrauterine restrictive
stress is very much involved in the genesis of CMT.Treatment is mainly based on
physiotherapy, it needs to be started early and associated with parental education. In the
event of a failure of the physical therapy, a surgical treatment can be considered. CMT is a
risk factor for delayed psychomotor development and can lead to long term sequelae in motor
coordination.
CMT comes with asymmetrical deformation of the skull or plagiocephaly. Skull deformation in
plagiocephaly is a 3D deformation affecting the calvaria, the skull base and the face. The
skull base asymmetry can be found at the mastoid process of the petrous bone, insertion of
the SCM on the base of the skull. The facial asymmetry in CMT can have an aesthetic impact on
the face or a functional impact on the long term occlusion. CMT also come with abnormalities
of the junction between the skull and the vertebrae, they impact the cervical mobility and
foster premature arthrosis. The CMT care will modify the seriousness of the skull and face
deformation, severity is major in neglected or not treated CMT.
Plagiocephly, facial asymmetry, skull and cranio-vertebral deformation in CMT are the results
of a complex mechanism of biomechanical stresses upon a developing skull. These stresses
appear in a context of intrauterine postural distortions and/or during postnatal distorting
sequences. The SCM responsible for CMT is inserted on the mastoid process of the petrous bone
for its base of the skull insertion, the petrous bone is a fundamental component in the
biomechanics of the base of the skull.
The hypothesis of a traction force on the base of the skull from the SCM could explain most
of all the 3D asymmetrical deformation encountered in CMT. It would be associated to a
compression force at the occipital level particularly linked to a sleep position of the
infants on their back, position that is now recommended.
The traction force is different depending on the CMT with no or little force in postural
torticollis and strong and constant forces in torticollis with fibrosis.
