Echotexture in Following Muscle Fibrosis

Congenital Muscular Torticollis Clinical Trial

Official title:

Longitudinal Follow-up of Muscle Echotextures in Infants With Congenital Muscular Torticollis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02889705
• Other study ID #: 100-4436B
• Status: Completed
• Phase: N/A
• First received: August 26, 2016
• Last updated: August 31, 2016
• Start date: August 2012

Study information

• Verified date: August 2016
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Chang Gung Memorial Hospital
• Study type: Observational

Clinical Trial Summary

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.

Description:

1. 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.

2. 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Month to 12 Months

Eligibility

Inclusion Criteria:

• infants with congenital muscular torticollis Presenting clinical features of the CMT infants, including head tilt in the upright position, facial asymmetry, limited passive range of motion in neck rotation, palpable neck mass

Exclusion Criteria:

• Subjects with neurological symptoms or signs

• Cervical spine abnormalities

• Developmental dysplastic hip problems

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Congenital Muscular Torticollis
• Torticollis

Intervention

Other:
• Ultrasonographic examination

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	K value	Difference of echo intensities on muscle sonograms between involved and uninvolved sternocleidomastoid muscles in 50 infants with congenital muscular torticollis	3 years	No
Primary	Muscle thickness in cm	Bilateral sternocleidomastoid muscle thickness in 50 infants with congenital muscular torticollis	3 years	No
Primary	Ratio I/U (involved-to-uninvolved muscle thickness ratio)		3 years	No
Primary	Age in month	The age of first evaluation	3 years	No
Primary	Times of ultrasonographic examinations	The times of ultrasonographic examination before end follow-up	3 years	No
Primary	Body weight in kg	Body weight of all subjects during the follow-up period	3 years	No
Primary	Body length in cm	Body length of all subjects during the follow-up period	3 years	No