Torticollis Congenital Clinical Trial
Official title:
Digital Analysis of Ultrasonographic Images in Children With Wry Neck
Torticollis is a clinical sign or symptom that could be the result of a variety of underlying
disorders. Among the etiologies, Congenital muscular torticollis (CMT) with impairment of the
sternocleidomastoid (SCM) is the most frequent cause of torticollis in infants. CMT is a
postural deformity detected at birth or shortly after birth, primarily resulting from
unilateral shortening and fibrosis of the SCM. Infants with CMT display head tilt to one
side, which is often combined with rotation of the head to the opposite side. In 2002,
Chih-Chin Hsu et al. reported that CMT could be classified into four types. The majority of
Type I and II fibrosis improved after conservative treatment. However, Type III and Type IV
had more probability in need of surgical correction. However, this categorization lacks of
objective and quantitative measurement and can be different by subjective judgement of
different physicians. The purpose of this study is tried to perform digital analysis of
ultrasonography images to establish an objective, quantitative method and to assess its
relevance with clinical symptoms and prognosis.
This study will collect the children younger than one year-old who were impressed or
suspected to have torticollis in physical medicine and rehabilitation clinic to assess the
relationship between digitalization results of ultrasound image and clinical manifestations
and prognosis. Digital image analysis of ultrasound which contains both sides of the SCM in
transverse and longitudinal view for comparison of lesion side and sound side will be
performed after the initial enrollment and every six months later. Evaluation of clinical
manifestations includes measurement of side difference of angles in bilateral neck lateral
flexion, rotation and habitual head position will performed using an arthrodial protractor by
a trained member at the beginning of physical therapy and one month later, then every 2-3
months. All cases will be followed for 1 and a half years. We expect to find some typical
characteristics of CMT through digital analysis of the SCM. These characteristics include the
muscle thickness and intensity of echogenicity in the region of interest. The Pearson's
correlation will be performed to analyze the relevance of quantitative side differences in
ultrasonography and clinical manifestations including side differences of neck rotation,
lateral flexion and habitual head position between lesion sides and sound sides.
Torticollis is a clinical sign or symptom that could be the result of a variety of underlying
disorders. Among the etiologies, Congenital muscular torticollis (CMT) with impairment of the
sternocleidomastoid (SCM) is the most frequent cause of torticollis in infants. CMT is a
postural deformity detected at birth or shortly after birth, primarily resulting from
unilateral shortening and fibrosis of the SCM muscle. Infants with CMT display head tilt to
one side, which is often combined with rotation of the head to the opposite side. CMT is
estimated to occur in one infant of every 300 live births. Plagiocephaly is reported as a
coexisting impairment in 80% to 90.1% of children with CMT.
The pathophysiology and etiology of SCM impairment in CMT is still unknown. Prominent
theories related to the cause of SCM impairment in CMT include intrauterine crowding, muscle
trauma during a difficult delivery, soft tissue compression leading to compartment syndrome,
and congenital abnormalities of soft tissue differentiation within the SCM muscle.
Children with CMT can be assigned to one of three clinical subgroups: 1) children with a
palpable swelling or pseudotumor of the sternocleidomastoid, 2) children with SCM tightness
but no tumor, and 3) children with all the features of muscular torticollis without muscle
tightness or tumor.
In 2002, Chih-Chin Hsu et al. reported that CMT could be classified into four types. Type I
denoted a heteroechoic mass in the affected muscles; Type II represented diffuse echogenic
dots and lines against the hypoechoic background with no detectable mass. The alignment of
perimysium appeared irregular instead of parallel on longitudinal sonograms; Type III
indicated diffuse hyperechoic echogenicity along the entire muscle and almost no hypoechoic
background could be seen; and Type IV had a hyperechoic band in the involved muscles. The
study also evaluated the histology of each type of fibrosis. Type I and II fibrosis revealed
hyperplastic fibrous tissue mingled with muscle fiber. Mature fibroblasts with complete
absence of normal muscle tissue could be found in Type III fibrosis and the fibrotic bands in
Type IV fibrosis. The majority of Type I and II fibrosis improved after conservative
treatment. However, Type III and Type IV had more probability in need of surgical correction.
However, this categorization lacks of objective and quantitative measurement and can be
different by subjective judgement of different physicians. The purpose of this study is tried
to perform digital analysis of ultrasonography images to establish an objective, quantitative
method and to assess its relevance with clinical symptoms and prognosis.
General Design:
This study is planned to quantify ultrasonography image of wry neck patients by digital
analysis.
Subjects:
This study will collect the children younger than 1 y/o who were impressed or suspected to
have torticollis in physical medicine and rehabilitation clinic. The case number is estimated
around 60 in a 3-year-period enrollment. . Exclusion criteria include torticollis by other
known causes like strabismus, trauma, neurogenic problems, congenital malformation or bony
deformity (e.g. hemivertebrae of cervical spine). Informed consent will be given to the
parents before enrollment.
Investigation Steps:
1. Ultrasonography examination and digital analysis:
Ultrasonography which contains both sides of the sternocleidomastoid muscle in
transverse and longitudinal view for comparison of lesion side and sound side will be
performed by expert physicians using a 14-megahertz linear-array transducer after the
initial enrollment and every six months later. Digital analysis of the images will be
carried by a member expert in computer science.
2. Evaluation of clinical manifestations:
Evaluation of clinical manifestations includes measurement of side difference of angles
in bilateral neck lateral flexion, rotation and habitual head position will performed
using an arthrodial protractor by a trained member at the beginning of physical therapy
and one month later, then every 2-3 months. Each measurement will be repeated 3 times to
get the mean value. All cases will be followed for 1 and a half years, however, if the
symptoms got completely recovery (the neck range of motion and position completely equal
to sound side) or any complications resulting from the evaluation, the evaluation will
be stopped.
3. Evaluation of influence of rehabilitation effect:
The parents will be inquired by a questionnaire one month later and then every 2-3 months to
realize the treatment effect of the wry neck. The duration and frequency of massage and
stretch programs by the therapist or the family or the other methods to treat the problem
like wearing a neck collar, proper positioning… etc will be included in the semi-quantitative
questionnaire.
Data Analysis:
Some representative image features will be expected to be computed from the SCM ultrasonic
images. These features include area, both max and min Feret's diameters, and brightness of
echogenicity in the region of interest. The ultrasonic image of the affected side would be
compared with that of the sound side from their corresponding texture features. The Pearson's
correlation will be performed to analyze the relevance of quantitative side differences of
texture features in ultrasonography and clinical manifestations including side differences of
neck rotation, lateral flexion and habitual head position between lesion sides and sound
sides. Linear regression will be also used to adjust the influence of the treatment effect.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT06015555 -
TAMO Therapy Versus Postural Control Exercise in Children With Congenital Muscular Torticollis
|
N/A |