Echotexture in Following Muscle Fibrosis
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02889705|
Recruitment Status : Completed
First Posted : September 5, 2016
Last Update Posted : September 5, 2016
Objective: To document the sternocleidomastoid (SCM) muscle fibrosis in congenital muscular torticollis (CMT) infants with quantified echotexture and measured thickness during the treatment course.
Design: Cohort study. Setting: Rehabilitation department in a tertiary care hospital. Participants: Infants with clinical diagnosis of CMT, without any neurological presentation, cervical spin abnormality, and developmental dysplastic hip problem, were recruited in the study.
Intervention: All subjects had physiotherapy for at least 3 months. They underwent at least two times of clinical assessment and ultrasonographic examination (1) for bilateral SCM muscles during the follow-up period.
End of follow-up: Subjects who still had prominent clinical presentations after physiotherapy for 6 months or were older than 1 year would receive surgery. Subsided presenting clinical features determined by the clinician was the other end-point of this investigation.
Main Outcome Measures: The K value, derived from the difference of echo intensities (2) between the involved and uninvolved SCM muscles on longitudinal sonograms, was used to represent the severity of muscle fibrosis in CMT infants. Bilateral SCM muscle thickness and involved-to-uninvolved thickness ratio (Ratio I/U) were also obtained from longitudinal sonograms. Clinical outcome was also recorded.
|Condition or disease||Intervention/treatment|
|Congenital Muscular Torticollis||Other: Ultrasonographic examination|
- An experienced sonographer performed ultrasonographic examination with the subject in the supine position and heads rotated contralaterally to the examination side. A 5-12 MHz linear-array ultrasound transducer was used to observe both longitudinal and transverse views of bilateral SCM muscles for each subject. The ultrasound system settings, including gain (86%), monitor dynamic range (70 dB), and depth (2 cm), were kept constant throughout the study.
- The echo intensity was determined by computer-assisted gray scale analysis and was calculated in MATLAB 2006b. The mean echo intensity of every pixel in the region of interest and the K value developed to compare sonograms between different individuals or between different times in the same subject were estimated as the previous study (PMID: 22215768)
|Study Type :||Observational|
|Actual Enrollment :||50 participants|
|Official Title:||Longitudinal Follow-up of Muscle Echotextures in Infants With Congenital Muscular Torticollis|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||July 2015|
- K value [ Time Frame: 3 years ]Difference of echo intensities on muscle sonograms between involved and uninvolved sternocleidomastoid muscles in 50 infants with congenital muscular torticollis
- Muscle thickness in cm [ Time Frame: 3 years ]Bilateral sternocleidomastoid muscle thickness in 50 infants with congenital muscular torticollis
- Ratio I/U (involved-to-uninvolved muscle thickness ratio) [ Time Frame: 3 years ]
- Age in month [ Time Frame: 3 years ]The age of first evaluation
- Times of ultrasonographic examinations [ Time Frame: 3 years ]The times of ultrasonographic examination before end follow-up
- Body weight in kg [ Time Frame: 3 years ]Body weight of all subjects during the follow-up period
- Body length in cm [ Time Frame: 3 years ]Body length of all subjects during the follow-up period