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Completed

NCT Number: NCT02889705

Echotexture in Following Muscle Fibrosis

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.

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Key information

Conditions

Congenital Muscular Torticollis Congenital torticollis

Age range

1 month–12 month

Sex eligibility

All sexes

Study type

Observational

About this study

  • 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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasonographic examination

Other

Primary outcomes

  1. 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

  2. Muscle thickness in cm

    Time frame: 3 years

    Bilateral sternocleidomastoid muscle thickness in 50 infants with congenital muscular torticollis

  3. Ratio I/U (involved-to-uninvolved muscle thickness ratio)

    Time frame: 3 years

  4. Age in month

    Time frame: 3 years

    The age of first evaluation

  5. Times of ultrasonographic examinations

    Time frame: 3 years

    The times of ultrasonographic examination before end follow-up

  6. Body weight in kg

    Time frame: 3 years

    Body weight of all subjects during the follow-up period

  7. Body length in cm

    Time frame: 3 years

    Body length of all subjects during the follow-up period

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
First posted
Sep 5, 2016
Registry last updated
Sep 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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